National Health (Listing of Pharmaceutical Benefits) Instrument 2024

Contents

Part 1 · Preliminary

1Name#

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Instrument 2024.

(2)This instrument may also be cited as PB 26 of 2024.

3Authority#

This instrument is made under sections 84AF, 84AK, 85, 85A and 88 of the National Health Act 1953.

4Simplified outline#

This instrument deals with a number of different matters concerning pharmaceutical benefits.

Part 2 defines pharmaceutical benefits, by identifying the drugs and medicinal preparations to which Part VII of the Act applies, and the forms, manners of administration and brands for those drugs and medicinal preparations. It also identifies the responsible person for brands and which brands are treated as equivalent to each other.

Part 3 deals with the rules for prescribing pharmaceutical benefits, including who can write prescriptions and the maximum quantities and number of repeats that can be prescribed.

Part 4 defines quantities of pharmaceutical benefits that are used for pricing purposes.

Part 5 identifies drugs and pharmaceutical benefits that can only be supplied in particular ways.

5Definitions#

Note 1: A number of expressions used in this instrument are defined in the Act, including the following:

(a) Chief Executive Medicare;

(b) hospital.

Note 2: Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:

(a) medical practitioner;

(b) medicare benefit.

In this instrument:

ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.

Act means the National Health Act 1953.

authorised midwife has the same meaning as in Part VII of the Act.

authorised nurse practitioner has the same meaning as in Part VII of the Act.

authorised optometrist has the same meaning as in Part VII of the Act.

authorised prescriber, of a pharmaceutical benefit, means a PBS prescriber (within the meaning of Part VII of the Act) who is authorised under section 12 of this instrument to write a prescription for the supply of the benefit.

brand, of a pharmaceutical item, has the same meaning as in Part VII of the Act.

CFC is short for chlorofluorocarbon.

CFU is short for colony forming unit.

circumstances code means the letter “C” followed by a number.

conditions code means the letters “CN” followed by a number.

extemporaneously-prepared pharmaceutical benefit means a pharmaceutical benefit that:

(a)is a listed drug mentioned in column 1 of the table in Part 1 of Schedule 2; or

(b)contains such a listed drug.

General statement for drugs for the treatment of hepatitis C means the statement set out in Schedule 6.

GP Management Plan means a comprehensive written plan for the treatment of a patient:

(a)that is prepared by a medical practitioner; and

(b)for the preparation of which a medicare benefit is payable; and

(c)that includes a description of the patient’s health care needs, management goals, actions to be taken by the patient, and treatment and services the patient is likely to need.

I.M. is short for intramuscular.

I.U. is short for international unit.

I.V. is short for intravenous.

listed drug has the same meaning as in Part VII of the Act.

Medicare Benefits Schedule means:

(a)the table, within the meaning of subsection 3(1) of the Health Insurance Act 1973; or

(b)any determination made under subsection 3C(1) of that Act.

palliative care patient means a patient with an active, progressive, far-advanced disease for whom the prognosis is limited and the focus of care is the quality of life.

participating dental practitioner has the same meaning as in Part VII of the Act.

pharmaceutical benefit has the same meaning as in Part VII of the Act.

pharmaceutical item has the same meaning as in Part VII of the Act.

purposes code means the letter “P” followed by a number.

ready-prepared pharmaceutical benefit means a pharmaceutical benefit that is mentioned in a table in Schedule 1.

streamlined authority code means the words “Streamlined Authority Code” followed by a number.

Team Care Arrangements means arrangements:

(a)that are coordinated by a medical practitioner; and

(b)for the coordination of which a medicare benefit is payable; and

(c)that, following consultation with collaborating providers, are documented in a plan that includes a description of the treatment and service goals for the patient, the treatment and services that all collaborating providers will provide, and the actions to be taken by the patient.

variation code means the letter “V” followed by a number.

Part 2 · Pharmaceutical benefits

6Drugs and medicinal preparations to which Part VII of the Act applies (Act s 85(2))#

Drugs and medicinal preparations—Schedule 1

(1)For the purposes of paragraph 85(2)(a) of the Act, Part VII of the Act applies to a drug or medicinal preparation mentioned in the column of a table in Schedule 1 to this instrument headed “Listed Drug”.

Drugs and medicinal preparations—Schedule 2

(2)For the purposes of paragraph 85(2)(a) of the Act, Part VII of the Act applies to:

(a)a drug or medicinal preparation mentioned in column 1 of the table in Part 1 of Schedule 2 to this instrument; and

(b)a medicinal preparation composed of one or more drugs or medicinal preparations mentioned in that column.

(3)For the purposes of paragraph 85(2)(b) of the Act, that paragraph applies to:

(a)the class of drugs and medicinal preparations consisting of the drugs and medicinal preparations mentioned in column 1 of the table in Part 1 of Schedule 2 to this instrument; and

(b)additives mentioned in the table in Part 2 of that Schedule.

Note: Part VII of the Act applies to medicinal preparations composed of one or more of the drugs and medicinal preparations included in the class mentioned in paragraph (a) of this subsection and one or more additives mentioned in paragraph (b) of this subsection—see paragraph 85(2)(b) of the Act.

7Form or forms of a listed drug (Act s 85(3))#

For the purposes of subsection 85(3) of the Act, the form or forms of a listed drug mentioned in a table in Schedule 1 to this instrument are the form or forms mentioned in relation to the listed drug in the column of the table headed “Form”.

8Manner of administration of a form of a listed drug (Act s 85(5))#

For the purposes of subsection 85(5) of the Act, the manner of administration of a form of a listed drug mentioned in a table in Schedule 1 to this instrument is the manner of administration mentioned in relation to the form of the drug in the column of the table headed “Manner of Administration”.

9Brand of a pharmaceutical item (Act s 85(6))#

For the purposes of subsection 85(6) of the Act, each brand mentioned in the column of a table in Schedule 1 to this instrument headed “Brand” in relation to a pharmaceutical item is a brand of the pharmaceutical item.

10Responsible person for a brand of a pharmaceutical item (Act s 84AF(1))#

For the purposes of subsection 84AF(1) of the Act, the responsible person for a brand of a pharmaceutical item mentioned in a table in Schedule 1 to this instrument is the person represented, in accordance with the table in Schedule 3, by the code mentioned in relation to the brand in the column of the table in Schedule 1 headed “Responsible Person”.

11Schedule equivalents of brands of pharmaceutical items (Act s 85(6A))#

For the purposes of subsection 85(6A) of the Act, a brand of a pharmaceutical item included in a schedule equivalent group in the table in Schedule 5 to this instrument is, for the purposes of paragraph 103(2A)(b) of the Act, to be treated as equivalent to each other brand of a pharmaceutical item that is included in that schedule equivalent group.

Part 3 · Prescription of pharmaceutical benefits

Division 1 · Authorised prescribers and prescription circumstances

12Authorised prescribers (Act s 88)#

Ready-prepared pharmaceutical benefits

(1)The following table has effect.

Authorised prescribers—ready-prepared pharmaceutical benefits
	Column 1	Column 2	Column 3
Item	For the purposes of the following Act provision …	the following kind of person …	is authorised to write a prescription for the supply of a ready-prepared pharmaceutical benefit in relation to which the following initials are mentioned in the column of the table in Part 1 of Schedule 1 to this instrument headed “Authorised Prescriber” …
1	subsection 88(1)	a medical practitioner	MP
2	subsection 88(1A)	a participating dental practitioner	PDP
3	subsection 88(1C)	an authorised optometrist	AO
4	subsection 88(1D)	an authorised midwife	MW
5	subsection 88(1E)	an authorised nurse practitioner	NP

Extemporaneously-prepared pharmaceutical benefits

(2)For the purposes of subsection 88(1) of the Act, a medical practitioner is authorised to write a prescription for the supply of an extemporaneously-prepared pharmaceutical benefit.

13Prescription of ready-prepared pharmaceutical benefits in certain circumstances (Act s 85(7))#

For the purposes of paragraphs 85(7)(a) and (b) of the Act, if a circumstances code is mentioned in the column of the table in Part 1 of Schedule 1 to this instrument headed “Circumstances” in relation to a pharmaceutical benefit:

(a)the pharmaceutical benefit is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and

(b)the circumstances mentioned in the column of the table in Part 1 of Schedule 4 to this instrument headed “Circumstances and Purposes” in relation to the circumstances code are circumstances in which a prescription for the supply of the pharmaceutical benefit may be written; and

(c)if the column of the table in Part 1 of Schedule 4 to this instrument headed “Authority Requirements” in relation to the circumstances code is not blank—it is part of the circumstances that writing the prescription must be authorised by the Chief Executive Medicare in accordance with section 19 of this instrument.

14Prescription of extemporaneously-prepared pharmaceutical benefits in certain circumstances (Act s 85(7))#

(1)If circumstances are mentioned in column 2 of an item in the table in Part 1 of Schedule 2, then:

(a)for the purposes of paragraph 85(7)(a) of the Act:

(i)the listed drug mentioned in column 1 of the item is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and

(ii)an extemporaneously-prepared pharmaceutical benefit that contains the listed drug is a relevant pharmaceutical benefit for the purposes of section 88A of the Act; and

(b)for the purposes of paragraph 85(7)(b) of the Act, the circumstances are circumstances in which a prescription may be written:

(i)for the supply of the listed drug; or

(ii)for the supply of a pharmaceutical benefit that is a relevant pharmaceutical benefit under subparagraph (a)(ii) of this subsection only because it contains the listed drug.

(2)If a pharmaceutical benefit contains 2 or more listed drugs that are relevant pharmaceutical benefits under subparagraph (1)(a)(i) (the component drugs), then, for the purposes of paragraph 85(7)(b) of the Act, a prescription for the supply of the pharmaceutical benefit may be written only if the circumstances mentioned in column 2 of the table in Part 1 of Schedule 2 to this instrument for every component drug exist.

Division 2 · Maximum quantities and repeats

15Maximum quantity (number of units)—ready-prepared pharmaceutical benefits (Act s 85A(2)(a), (2A) and (3A))#

Purpose of section

(1)This section determines, with respect to the writing of prescriptions for the supply of a ready-prepared pharmaceutical benefit having a pharmaceutical item by authorised prescribers of the benefit:

(a)for the purposes of paragraph 85A(2)(a) of the Act—the maximum number of units of the pharmaceutical item that may, in one prescription, be directed to be supplied on any one occasion; and

(b)for the purposes of subsection 85A(2A) of the Act—conditions that must be satisfied when writing a prescription; and

(c)for the purposes of subsection 85A(3A) of the Act—rules that must be applied when deciding whether to authorise a variation of the application of a determination referred to in paragraph (a) of this subsection.

Determination of maximum number of units

(2)If only one number of units is mentioned in the column of the table in Part 1 of Schedule 1 to this instrument headed “Maximum Quantity” in relation to brands of the pharmaceutical item and a kind of authorised prescriber, that number of units is the maximum number of units of the pharmaceutical item for that kind of authorised prescriber for all purposes.

(3)If more than one number of units is mentioned in the column of the table in Part 1 of Schedule 1 headed “Maximum Quantity” in relation to brands of the pharmaceutical item and a kind of authorised prescriber, then:

(a)if a purposes code is mentioned in the column of the table headed “Purposes” in relation to a number of units—that number is the maximum number of units of the pharmaceutical item for that kind of authorised prescriber for the purposes mentioned in the table in Part 1 of Schedule 4 for that purposes code; and

(b)if no purposes code is mentioned in that column in relation to a number of units—that number is the maximum number of units of the pharmaceutical item for that kind of authorised prescriber for all purposes other than purposes to which paragraph (a) applies.

Conditions for writing prescription

(4)If the column of the table in Part 1 of Schedule 1 headed “Maximum Quantity” includes a conditions code together with a maximum number of units, it is a condition when writing a prescription to which that maximum applies that writing the prescription must be authorised by the Chief Executive Medicare in accordance with section 19 of this instrument.

Rules for authorising variation of maximum number of units

(5)If the column of the table in Part 1 of Schedule 1 headed “Variations” includes a variation code in relation to a maximum number of units, the rules mentioned in the column of the table in Part 2 of Schedule 4 headed “Variation Rules” in relation to the variation code must be applied when deciding whether to authorise a variation of that maximum (to the extent that those rules relate to the number of units).

Note: Rules may also relate to the maximum number of repeats.

16Maximum number of repeats—ready-prepared pharmaceutical benefits (Act s 85A(2)(b), (2A) and (3A))#

Purpose of section

(1)This section determines, with respect to the writing of prescriptions for the supply of a ready-prepared pharmaceutical benefit by authorised prescribers of the benefit:

(a)for the purposes of paragraph 85A(2)(b) of the Act—the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated; and

(b)for the purposes of subsection 85A(2A) of the Act—conditions that must be satisfied when writing a prescription; and

Determination of maximum number of repeats

(2)If only one number is mentioned in the column of the table in Part 1 of Schedule 1 to this instrument headed “Number of Repeats” in relation to the pharmaceutical benefit and a kind of authorised prescriber, that number is the maximum number of occasions for that kind of authorised prescriber for all purposes.

(3)If more than one number is mentioned in the column of the table in Part 1 of Schedule 1 headed “Number of Repeats” in relation to the pharmaceutical benefit and a kind of authorised prescriber, then:

(a)if a purposes code is mentioned in the column of the table headed “Purposes” in relation to a number—that number is the maximum number of occasions for that kind of authorised prescriber for the purposes mentioned in the table in Part 1 of Schedule 4 for that purposes code; and

(b)if no purposes code is mentioned in that column in relation to a number—that number is the maximum number of occasions for that kind of authorised prescriber for all purposes other than purposes to which paragraph (a) applies.

Conditions for writing prescription

(4)If the column of the table in Part 1 of Schedule 1 headed “Number of Repeats” includes a conditions code together with a maximum number of occasions that supply may be directed to be repeated, it is a condition when writing a prescription to which that maximum applies that writing the prescription must be authorised by the Chief Executive Medicare in accordance with section 19 of this instrument.

Rules for authorising variation of maximum number of repeats

(5)If the column of the table in Part 1 of Schedule 1 headed “Variations” includes a variation code in relation to a maximum number of repeats, the rules mentioned in the column of the table in Part 2 of Schedule 4 headed “Variation Rules” in relation to the variation code must be applied when deciding whether to authorise a variation of that maximum (to the extent that those rules relate to the number of repeats).

Note: Rules may also relate to the maximum number of units.

17Maximum quantity—extemporaneously-prepared pharmaceutical benefits (Act s 85A(2)(a))#

For the purposes of paragraph 85A(2)(a) of the Act, the maximum quantity of an extemporaneously-prepared pharmaceutical benefit, of a type mentioned in column 1 of an item in the table in Part 3 of Schedule 2 to this instrument, that a medical practitioner may, in one prescription, direct to be supplied on any one occasion is the quantity mentioned in column 2 of the item.

18Maximum number of repeats—extemporaneously-prepared pharmaceutical benefits (Act s 85A(2)(b))#

For the purposes of paragraph 85A(2)(b) of the Act, the maximum number of occasions that a medical practitioner may, in one prescription, direct that the supply of an extemporaneously-prepared pharmaceutical benefit, of a type mentioned in column 1 of an item in the table in Part 3 of Schedule 2 to this instrument, be repeated is the number mentioned in column 3 of the item.

Division 3 · Authorisation of prescriptions

19Authority required procedures#

(1)This section applies if:

(a)the circumstances under paragraph 85(7)(b) of the Act in which a prescription for the supply of a pharmaceutical benefit may be written; or

(b)the conditions under subsection 85A(2A) of the Act for writing a prescription for the supply of a pharmaceutical benefit;

include a requirement that writing the prescription must be authorised by the Chief Executive Medicare.

Obtaining authority

(2)When requesting authority to write a prescription, an authorised prescriber must provide details of the proposed prescription to the Chief Executive Medicare.

(3)If the column of the table in Part 1 of Schedule 4 to this instrument headed “Authority Requirements” contains the statement “Compliance with Written Authority Required procedures”, the details must be provided in writing.

(4)If the Chief Executive Medicare gives authority to write the prescription, the Chief Executive Medicare must allot a number to the prescription and tell the authorised prescriber that number.

Note: For requirements to write the allotted number on the prescription, see sections 40 and 41 of the National Health (Pharmaceutical Benefits) Regulations 2017.

Deemed authority

(5)If the column of the table in Part 1 of Schedule 4 headed “Authority Requirements” includes a streamlined authority code, writing the prescription is taken to have been authorised by the Chief Executive Medicare.

Note: For requirements to write the streamlined authority code on the prescription, see sections 40 and 41 of the National Health (Pharmaceutical Benefits) Regulations 2017.

Part 4 · Quantities of pharmaceutical items

20Pack quantity (Act s 84AK(2))#

For the purposes of subsection 84AK(2) of the Act, a number of units of a pharmaceutical item mentioned in the column of a table in Schedule 1 to this instrument headed “Pack Quantity” in relation to a brand of the pharmaceutical item is a pack quantity of the brand.

21Determined quantity (Act s 84AK(3))#

For the purposes of subsection 84AK(3) of the Act, a number of units of a pharmaceutical item mentioned in the column of a table in Schedule 1 to this instrument headed “Determined Quantity” in relation to a brand of the pharmaceutical item is a determined quantity of the brand.

Part 5 · Supply of pharmaceutical benefits

22Listed drugs and pharmaceutical benefits that can only be supplied under the prescriber bag provisions (Act s 85(2AA) and (7A))#

Listed drugs

(1)For the purposes of subsection 85(2AA) of the Act, if one or more of the codes “D(MP)”, “D(MW)” and “D(NP)” are mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to a listed drug, then the listed drug can only be supplied under:

(a)if the code D(MP) is mentioned—section 93 of the Act (prescriber bag supplies—medical practitioners); and

(b)if the code D(MW) is mentioned—section 93AA of the Act (prescriber bag supplies—authorised midwives); and

(c)if the code D(NP) is mentioned—section 93AB of the Act (prescriber bag supplies—authorised nurse practitioners).

Pharmaceutical benefits

(2)For the purposes of subsection 85(7A) of the Act, if one or more of the codes “PB(MP)”, “PB(MW)” and “PB(NP)” are mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to a pharmaceutical benefit, then the pharmaceutical benefit can only be supplied in accordance with the following:

(a)if the code PB(MP) is mentioned—section 93 of the Act (prescriber bag supplies—medical practitioners);

(b)if the code PB(MW) is mentioned—section 93AA of the Act (prescriber bag supplies—authorised midwives);

(c)if the code PB(NP) is mentioned—section 93AB of the Act (prescriber bag supplies—authorised nurse practitioners).

Note: For the interaction between a declaration under subsection 85(2AA) of the Act in relation to a drug and a declaration under subsection 85(7A) of the Act in relation to a pharmaceutical benefit that has the drug, see subsection 85AAA(3) of the Act.

23Listed drugs and pharmaceutical benefits that can be supplied only under special arrangements (Act s 85(2A) and (8))#

Listed drugs

(1)For the purposes of subsection 85(2A) of the Act, a listed drug can be supplied only under special arrangements under section 100 of the Act if the code “D(100)” is mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to the drug.

Pharmaceutical benefits

(2)For the purposes of paragraph 85(8)(a) of the Act, a ready-prepared pharmaceutical benefit can be supplied only under special arrangements under section 100 of the Act if the code “PB(100)” is mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to the pharmaceutical benefit.

Circumstances

(3)For the purposes of paragraph 85(8)(b) of the Act, if the code “C(100)” is mentioned in the column of a table in Schedule 1 to this instrument headed “Section 100/Prescriber Bag only” in relation to a pharmaceutical benefit and a circumstances code, the circumstances mentioned in the table in Part 1 of Schedule 4 for the circumstances code are circumstances in which the pharmaceutical benefit can be supplied only under special arrangements under section 100 of the Act.

Part 6 · Application, saving and transitional provisions

24Transitional provision—authorisation of prescriptions#

(1)This section applies in relation to prescriptions for the supply of pharmaceutical benefits written before 1 July 2024.

(2)Despite the repeal of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012:

(a)an authorised prescriber may submit a prescription to the Chief Executive Medicare in accordance with section 12 of that instrument as in force immediately before 1 April 2024; and

(b)the Chief Executive Medicare may authorise the prescription in accordance with section 13 of that instrument as in force immediately before 1 April 2024; and

(c)if the prescription is so authorised, writing the prescription is taken to have been authorised in accordance with section 19 of this instrument.

(3)If the Chief Executive Medicare authorises a prescription under subsection 13(1), (1A) or (1B) of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 as in force immediately before 1 April 2024, the authorised prescriber is not required to comply with the following provisions of the National Health (Pharmaceutical Benefits) Regulations 2017 in relation to the prescription:

(a)paragraph 40(1)(i);

(b)paragraph 41(3)(a).

Schedule 5 · Schedule equivalent groups of brands of pharmaceutical items

Note: See section 11.

1Schedule equivalent groups of brands of pharmaceutical items#

The following table sets out schedule equivalent groups and the brands of pharmaceutical items included in the groups, for the purposes of section 11.

Listed Drug	Schedule Equivalent Group	Form	Manner of Administration	Brand
Abiraterone	GRP-29232	Tablet containing abiraterone acetate 250 mg	Oral	Abiraterone Dr.Reddy'sAbiraterone MedTasAbiraterone SandozAbiraterone-TevaABIRATERONE VIATRISARX-ABIRATERONEZYRONZytiga
Abiraterone	GRP-29234	Tablet containing abiraterone acetate 500 mg	Oral	Abiraterone Dr.Reddy'sAbiraterone MedTasAbiraterone SandozAbiraterone-TevaABIRATERONE VIATRISARX-ABIRATERONEZYRONZytiga
Acamprosate	GRP-22217	Tablet (enteric coated) containing acamprosate calcium 333 mg	Oral	ACAMPROSATE VIATRISACAMPROSATE-WGRAPO-AcamprosateCampral
Acarbose	GRP-20667	Tablet 100 mg	Oral	Acarbose ViatrisGLYBOSAY
Acarbose	GRP-20669	Tablet 50 mg	Oral	Acarbose ViatrisGLYBOSAY
Aciclovir	GRP-913	Tablet 200 mg	Oral	Aciclovir SandozAPO-AciclovirARX-ACICLOVIR
Aciclovir	GRP-914	Tablet 200 mg	Oral	Aciclovir GHAciclovir SandozACICLOVIR-WGRAPO-AciclovirARX-ACICLOVIR
Aciclovir	GRP-916	Tablet 800 mg	Oral	Aciclovir SandozACICLOVIR-WGRAPO-AciclovirARX-ACICLOVIR
Aciclovir	GRP-22911	Eye ointment 30 mg per g, 4.5 g	Application to the eye	ViruPOSXOROX
Acitretin	GRP-14341	Capsule 10 mg	Oral	NeotigasonZETIN
Acitretin	GRP-14344	Capsule 25 mg	Oral	NeotigasonZETIN
Adalimumab	GRP-24872	Injection 40 mg in 0.4 mL pre-filled pen	Injection	HadlimaHumiraHyrimozYuflyma
Adalimumab	GRP-24872	Injection 40 mg in 0.8 mL pre-filled pen	Injection	AbriladaAmgevitaHadlimaHyrimoz
Adalimumab	GRP-24874	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	HumiraYuflyma
Adalimumab	GRP-24874	Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita
Adalimumab	GRP-24876	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	HadlimaHumiraHyrimozYuflyma
Adalimumab	GRP-24876	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	AmgevitaHadlimaHyrimoz
Adalimumab	GRP-29112	Injection 80 mg in 0.8 mL pre-filled syringe	Injection	HumiraYuflyma
Adalimumab	GRP-29113	Injection 80 mg in 0.8 mL pre-filled pen	Injection	HumiraHyrimozYuflyma
Adrenaline (epinephrine)	GRP-22287	I.M. injection 300 micrograms in 0.3 mL (as acid tartrate) single dose syringe auto-injector	Injection	Jext
Adrenaline (epinephrine)	GRP-22287	I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector	Injection	Adrenaline ViatrisAnapen 300EpiPen
Adrenaline (epinephrine)	GRP-22289	I.M. injection 150 micrograms in 0.15 mL (as acid tartrate) single dose syringe auto-injector	Injection	Jext Jnr
Adrenaline (epinephrine)	GRP-22289	I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector	Injection	Adrenaline Jr ViatrisAnapen Junior 150EpiPen Jr.
Aflibercept	GRP-16279	Solution for intravitreal injection 3.6 mg in 90 microlitres (40 mg per mL) pre-filled syringe	Injection	Eylea
Aflibercept	GRP-16279	Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL)	Injection	Eylea
Aflibercept	GRP-16279	Solution for intravitreal injection 6.6 mg in 165 microlitres (40 mg per mL) pre-filled syringe	Injection	Afqlir
Aflibercept	GRP-30410	Solution for intravitreal injection 11.43 mg in 100 microlitres (114.3 mg per mL)	Injection	Eylea
Aflibercept	GRP-30410	Solution for intravitreal injection 11.43 mg in 100 microlitres (114.3 mg per mL) pre-filled syringe	Injection	Eylea
Alendronic acid	GRP-1155	Tablet 70 mg (as alendronate sodium)	Oral	Alendronate SandozALENDRONATE-WGRAPO-AlendronateFonat
Allopurinol	GRP-979	Tablet 100 mg	Oral	Allopurinol SandozALLOPURINOL-WGRAllosigAPO-ALLOPURINOLProgout 100Progout ViatrisZyloprim
Allopurinol	GRP-980	Tablet 300 mg	Oral	Allopurinol SandozALLOPURINOL-WGRAllosigAPO-ALLOPURINOLProgout 300Progout ViatrisZyloprim
Alprazolam	GRP-1055	Tablet 1 mg	Oral	Alprax 1Kalma 1
Alprazolam	GRP-1058	Tablet 500 micrograms	Oral	Alprax 0.5Kalma 0.5
Amantadine	GRP-28249	Capsule containing amantadine hydrochloride 100 mg	Oral	AMANTAMEDSymmetrel 100
Ambrisentan	GRP-24350	Tablet 10 mg	Oral	Ambrisentan ViatrisCipla AmbrisentanPULMORISVolibris
Ambrisentan	GRP-24370	Tablet 5 mg	Oral	Ambrisentan ViatrisPULMORISVolibris
Amiodarone	GRP-798	Tablet containing amiodarone hydrochloride 100 mg	Oral	Aratac 100Cordarone X 100
Amiodarone	GRP-799	Tablet containing amiodarone hydrochloride 200 mg	Oral	AmdaroneAmiodarone SandozAratac 200Cordarone X 200
Amisulpride	GRP-677	Tablet 100 mg	Oral	Amisulpride Sandoz PharmaAPO-AmisulprideSolian 100Sulprix
Amisulpride	GRP-678	Tablet 200 mg	Oral	Amisulpride Sandoz PharmaAMISULPRIDE-WGRAPO-AmisulprideSolian 200Sulprix
Amisulpride	GRP-679	Tablet 400 mg	Oral	Amisulpride Sandoz PharmaAMISULPRIDE-WGRAPO-AmisulprideSolian 400Sulprix
Amitriptyline	GRP-15192	Tablet containing amitriptyline hydrochloride 10 mg	Oral	Amitriptyline LupinAmitriptyline Viatris 10AMITRIPTYLINE-WGRAPX-AmitriptylineEndep 10ENTRIP
Amitriptyline	GRP-15194	Tablet containing amitriptyline hydrochloride 25 mg	Oral	Amitriptyline LupinAmitriptyline Viatris 25AMITRIPTYLINE-WGRAPX-AmitriptylineEndep 25ENTRIP
Amitriptyline	GRP-15196	Tablet containing amitriptyline hydrochloride 50 mg	Oral	Amitriptyline LupinAmitriptyline Viatris 50APX-AmitriptylineEndep 50ENTRIP
Amlodipine	GRP-1041	Tablet 10 mg (as besilate)	Oral	Amlo 10Amlodipine GHAmlodipine SandozAMLODIPINE-WGRAPO-AmlodipineAPX-AMLODIPINEBlooms AmlodipineNordipNorvascPharmacor Amlodipine
Amlodipine	GRP-1043	Tablet 5 mg (as besilate)	Oral	Amlo 5Amlodipine GHAmlodipine SandozAMLODIPINE-WGRAPO-AmlodipineAPX-AMLODIPINEBlooms AmlodipineNordipNorvascPharmacor Amlodipine
Amlodipine with atorvastatin	GRP-707	Tablet 10 mg amlodipine (as besilate) with 10 mg atorvastatin (as calcium)	Oral	Cadivast 10/10Caduet 10/10
Amlodipine with atorvastatin	GRP-708	Tablet 10 mg amlodipine (as besilate) with 20 mg atorvastatin (as calcium)	Oral	Cadivast 10/20Caduet 10/20
Amlodipine with atorvastatin	GRP-709	Tablet 10 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)	Oral	Cadivast 10/40Caduet 10/40
Amlodipine with atorvastatin	GRP-710	Tablet 10 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)	Oral	Cadivast 10/80Caduet 10/80
Amlodipine with atorvastatin	GRP-713	Tablet 5 mg amlodipine (as besilate) with 40 mg atorvastatin (as calcium)	Oral	Cadivast 5/40Caduet 5/40
Amlodipine with atorvastatin	GRP-714	Tablet 5 mg amlodipine (as besilate) with 80 mg atorvastatin (as calcium)	Oral	Cadivast 5/80Caduet 5/80
Amlodipine with valsartan	GRP-6765	Tablet 5 mg (as besilate)-80 mg	Oral	Amlodipine/Valsartan Novartis 5/80Exforge 5/80
Amlodipine with valsartan	GRP-22178	Tablet 10 mg (as besilate)-160 mg	Oral	Amlodipine/Valsartan Novartis 10/160Exforge 10/160
Amlodipine with valsartan	GRP-22180	Tablet 5 mg (as besilate)-160 mg	Oral	Amlodipine/Valsartan Novartis 5/160Exforge 5/160
Amlodipine with valsartan	GRP-22182	Tablet 10 mg (as besilate)-320 mg	Oral	Amlodipine/Valsartan Novartis 10/320Exforge 10/320
Amlodipine with valsartan	GRP-22184	Tablet 5 mg (as besilate)-320 mg	Oral	Amlodipine/Valsartan Novartis 5/320Exforge 5/320
Amlodipine with valsartan and hydrochlorothiazide	GRP-6767	Tablet 5 mg (as besilate)-160 mg-12.5 mg	Oral	Amlodipine/Valsartan/HCT Novartis 5/160/12.5Exforge HCT 5/160/12.5
Amlodipine with valsartan and hydrochlorothiazide	GRP-22186	Tablet 10 mg (as besilate)-160 mg-12.5 mg	Oral	Amlodipine/Valsartan/HCT Novartis 10/160/12.5Exforge HCT 10/160/12.5
Amlodipine with valsartan and hydrochlorothiazide	GRP-22188	Tablet 10 mg (as besilate)-160 mg-25 mg	Oral	Amlodipine/Valsartan/HCT Novartis 10/160/25Exforge HCT 10/160/25
Amlodipine with valsartan and hydrochlorothiazide	GRP-22190	Tablet 5 mg (as besilate)-160 mg-25 mg	Oral	Amlodipine/Valsartan/HCT Novartis 5/160/25Exforge HCT 5/160/25
Amlodipine with valsartan and hydrochlorothiazide	GRP-22192	Tablet 10 mg (as besilate)-320 mg-25 mg	Oral	Amlodipine/Valsartan/HCT Novartis 10/320/25Exforge HCT 10/320/25
Amoxicillin	GRP-815	Capsule 250 mg (as trihydrate)	Oral	Alphamox 250AMILOXYNAPO-AmoxycillinCilamox
Amoxicillin	GRP-816	Capsule 500 mg (as trihydrate)	Oral	Alphamox 500AMILOXYNAMOXICILLIN-WGRAmoxilAmoxycillin generichealth 500Amoxycillin SandozAPO-AmoxycillinBlooms The Chemist AmoxicillinCilamox
Amoxicillin	GRP-817	Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL	Oral	AMOXICILLIN MEDSURGEAmoxilAmoxycillin SandozAPO-Amoxycillin
Amoxicillin	GRP-818	Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL	Oral	AMOXICILLIN MEDSURGEAMOXICILLIN-WGRAmoxil ForteAmoxycillin SandozAPO-Amoxycillin
Amoxicillin	GRP-819	Tablet 1 g (as trihydrate)	Oral	Amoxycillin SandozMaxamox
Amoxicillin with clavulanic acid	GRP-828	Powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL	Oral	Augmentin Duo 400Curam Duo
Amoxicillin with clavulanic acid	GRP-829	Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	Alphaclav Duo ViatrisAMCLAVOX DUO 500/125AMOXICILLIN/CLAVULANIC ACID-WGR 500/125APO-AMOXY/CLAV 500/125APO-Amoxycillin/ Clavulanic Acid 500/125APX-Amoxicillin/Clavulanic AcidAugmentin DuoCOMOXCuram Duo 500/125
Amoxicillin with clavulanic acid	GRP-830	Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	Alphaclav Duo Forte ViatrisAMCLAVOX DUO FORTE 875/125AMOXICILLIN/CLAVULANIC ACID-WGR 875/125AmoxyClav generichealth 875/125APO-AMOXY/CLAV 875/125APO-Amoxycillin and Clavulanic AcidAPX-Amoxicillin/Clavulanic AcidAugmentin Duo forteBlooms The Chemist Amoxicillin/Clavulanic Acid 875/125COMOXCuram Duo Forte 875/125
Anastrozole	GRP-1187	Tablet 1 mg	Oral	Anastrozole GHAnastrozole SandozANASTROZOLE-WGRAPO-AnastrozoleArianna 1
Apixaban	GRP-31009	Tablet 2.5 mg	Oral	ApexaApixaban-APXApixaban Dr.Reddy'sCip Apixaban 2.5EliquisMSN-APIXABAN
Apixaban	GRP-31011	Tablet 2.5 mg	Oral	ApexaApixaban Dr.Reddy'sCip Apixaban 2.5EliquisMSN-APIXABAN
Apixaban	GRP-31028	Tablet 5 mg	Oral	ApexaApixaban-APXApixaban Dr.Reddy'sApixaban LupinApixaban SandozApixaban ViatrisAPIXABAN-WGRAPO-ApixabanCip Apixaban 5EliquisMSN-APIXABAN
Apixaban	GRP-31030	Tablet 2.5 mg	Oral	ApexaApixaban-APXApixaban Dr.Reddy'sApixaban LupinApixaban SandozApixaban ViatrisAPIXABAN-WGRAPO-ApixabanCip Apixaban 2.5EliquisMSN-APIXABAN
Apomorphine	GRP-22687	Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen	Injection	Apomine IntermittentMovapo Pen
Aprepitant	GRP-23349	Capsule 165 mg	Oral	Aprepitant APOTEXAPREPITANT SCP
Aripiprazole	GRP-20653	Tablet 10 mg	Oral	AbilifyAbyrazAPO-AripiprazoleAripiprazole GHAripiprazole SandozARIPIPRAZOLE-WGRARIZOLE
Aripiprazole	GRP-20655	Tablet 15 mg	Oral	AbilifyAbyrazAPO-AripiprazoleAripiprazole GHAripiprazole SandozARIPIPRAZOLE-WGRARIZOLE
Aripiprazole	GRP-20657	Tablet 20 mg	Oral	AbilifyAbyrazAPO-AripiprazoleAripiprazole GHAripiprazole SandozARIZOLE
Aripiprazole	GRP-20659	Tablet 30 mg	Oral	AbilifyAbyrazAPO-AripiprazoleAripiprazole GHAripiprazole SandozARIPIPRAZOLE-WGRARIZOLE
Aripiprazole	GRP-29736	Powder for injection 400 mg (as monohydrate) with diluent	Injection	Abilify MaintenaARIPENA
Atenolol	GRP-881	Tablet 50 mg	Oral	APX-AtenololAtenolol GHAtenolol SandozATENOLOL-WGRBlooms The Chemist AtenololNotenTenorminTensig
Atomoxetine	GRP-20842	Capsule 10 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atomoxetine	GRP-20845	Capsule 18 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atomoxetine	GRP-20847	Capsule 25 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atomoxetine	GRP-20849	Capsule 40 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atomoxetine	GRP-20852	Capsule 60 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atomoxetine	GRP-20853	Capsule 80 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atomoxetine	GRP-20855	Capsule 100 mg (as hydrochloride)	Oral	APO-AtomoxetineAtomoxetine Sandoz
Atorvastatin	GRP-1196	Tablet 10 mg (as calcium)	Oral	APO-AtorvastatinATOMEDAtorvacholAtorvastatin SZATORVASTATIN-WGRBTC AtorvastatinLipitorLorstat 10Pharmacor AtorvastatinTrovas
Atorvastatin	GRP-1197	Tablet 20 mg (as calcium)	Oral	APO-AtorvastatinATOMEDAtorvacholAtorvastatin SZATORVASTATIN-WGRBTC AtorvastatinLipitorLorstat 20Pharmacor AtorvastatinTrovas
Atorvastatin	GRP-1198	Tablet 40 mg (as calcium)	Oral	APO-AtorvastatinATOMEDAtorvacholAtorvastatin SZATORVASTATIN-WGRBTC AtorvastatinLipitorLorstat 40Pharmacor AtorvastatinTrovas
Atorvastatin	GRP-1199	Tablet 80 mg (as calcium)	Oral	APO-AtorvastatinATOMEDAtorvacholAtorvastatin SZATORVASTATIN-WGRBTC AtorvastatinLipitorLorstat 80Pharmacor AtorvastatinTrovas
Atovaquone	GRP-29252	Oral suspension 750 mg per 5 mL, 210 mL	Oral	ATOVACUEWellvone
Atovaquone with proguanil	GRP-27387	Tablet containing atovaquone 250 mg with proguanil hydrochloride 100 mg	Oral	AtovaquoPro Lupin 250/100Malarone
Azacitidine	GRP-20647	Powder for injection 100 mg	Injection	Azacitidine AccordAzacitidine Dr.Reddy'sAzacitidine JunoAzacitidine MSNAzacitidine SXP
Azathioprine	GRP-894	Tablet 25 mg	Oral	APO-AzathioprineAzathioprine SandozAZATHIOPRINE-WGRImuran
Azathioprine	GRP-895	Tablet 50 mg	Oral	APO-AzathioprineAzapinAzathioprine SandozAZATHIOPRINE-WGRImazanImuranThioprine 50
Azithromycin	GRP-1101	Tablet 500 mg (as dihydrate)	Oral	APO-AzithromycinAzithromycin SandozAzithromycin ViatrisAZITHROMYCIN-WGRZITHROZithromax
Baclofen	GRP-902	Tablet 10 mg	Oral	APO-BaclofenClofen 10Lioresal 10Stelax 10
Baclofen	GRP-903	Tablet 25 mg	Oral	APO-BaclofenClofen 25Lioresal 25Stelax 25
Baclofen	GRP-20578	Intrathecal injection 10 mg in 5 mL	Injection	BacthecalLioresal IntrathecalSintetica Baclofen Intrathecal
Beclometasone with formoterol	GRP-30494	Pressurised inhalation containing beclometasone dipropionate 100 micrograms and formoterol fumarate dihydrate 6 micrograms per dose,120 dose	Inhalation by mouth	Cipla Beclometasone/Formoterol 100/6Fostair
Beclometasone with formoterol	GRP-30496	Pressurised inhalation containing beclometasone dipropionate 200 micrograms and formoterol fumarate dihydrate 6 micrograms per dose, 120 doses	Inhalation by mouth	Cipla Beclometasone/Formoterol 200/6Fostair 200/6
Benzathine benzylpenicillin	GRP-28195	Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe	Injection	Bicillin L-A
Benzathine benzylpenicillin	GRP-28195	Powder for injection 1,200,000 units (s19A)	Injection	Benzylpenicillin benzathine (Brancaster Pharma, UK)
Benzathine benzylpenicillin	GRP-28195	Powder for injection 1,200,000 units with diluent 4 mL (S19A)	Injection	Lentocilin S 1200 (Portugal)
Benzathine benzylpenicillin	GRP-28195	Powder for injection 1,200,000 units with diluent 4 mL (Spain) (s19A)	Injection	Benzetacil (Spain)
Benzylpenicillin	GRP-31062	Powder for injection 600 mg (as sodium)	Injection	BenPenPEN G Sandoz
Betamethasone	GRP-965	Cream 500 micrograms (as dipropionate) per g, 15 g	Application	DiprosoneDIPROVANTEleuphrat
Betamethasone	GRP-966	Ointment 500 micrograms (as dipropionate) per g, 15 g	Application	DiprosoneDIPROVANTEleuphrat
Betamethasone	GRP-967	Cream 200 micrograms (as valerate) per g, 100 g	Application	Betnovate 1/5Cortival 1/5
Betamethasone	GRP-968	Cream 200 micrograms (as valerate) per g, 100 g	Application	AntroquorilCelestone-M
Betamethasone	GRP-969	Cream 500 micrograms (as valerate) per g, 15 g	Application	Betnovate 1/2Cortival 1/2
Bicalutamide	GRP-1156	Tablet 50 mg	Oral	APO-BicalutamideBicaloxCalutexCosamide 50Cosudex
Bimatoprost	GRP-21700	Eye drops 300 micrograms per mL, 3 mL	Application to the eye	Bimatoprost SandozBIMATOPROST-WGRBimproztLumigan
Bisacodyl	GRP-974	Suppositories 10 mg, 10	Rectal	DulcolaxPetrus Bisacodyl Suppositories
Bisoprolol	GRP-680	Tablet containing bisoprolol fumarate 10 mg	Oral	APO-BisoprololBicard 10BicorBisoprolol generichealthBisoprolol SandozBISOPROLOL-WGRBispro 10
Bisoprolol	GRP-681	Tablet containing bisoprolol fumarate 2.5 mg	Oral	APO-BisoprololBicard 2.5BicorBisoprolol generichealthBisoprolol SandozBISOPROLOL-WGRBispro 2.5
Bisoprolol	GRP-682	Tablet containing bisoprolol fumarate 5 mg	Oral	APO-BisoprololBicard 5BicorBisoprolol generichealthBisoprolol SandozBISOPROLOL-WGRBispro 5
Bivalirudin	GRP-21104	Powder for I.V. injection 250 mg (as trifluoroacetate)	Injection	BIVALIRUDIN ARXBIVALIRUDIN MEDSURGE
Bosentan	GRP-21580	Tablet 62.5 mg (as monohydrate)	Oral	Bosentan APOBOSENTAN DR.REDDY'SBosentan RBX
Bosentan	GRP-21582	Tablet 125 mg (as monohydrate)	Oral	Bosentan APOBOSENTAN DR.REDDY'SBosentan GHBosentan RBXBosentan Viatris
Brimonidine	GRP-1241	Eye drops containing brimonidine tartrate 2 mg per mL, 5 mL	Application to the eye	AlphaganEnidin
Brinzolamide	GRP-1291	Eye drops 10 mg per mL, 5 mL	Application to the eye	AzoptBrinzoQuin
Budesonide with formoterol	GRP-22099	Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses	Inhalation by mouth	Bufomix EASYHALER 200/6DuoResp SpiromaxRilast TURBUHALER 200/6Symbicort Turbuhaler 200/6
Budesonide with formoterol	GRP-22100	Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses	Inhalation by mouth	Bufomix Easyhaler 400/12DuoResp SpiromaxRilast TURBUHALER 400/12Symbicort TURBUHALER 400/12
Budesonide with formoterol	GRP-27468	Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses	Inhalation by mouth	Rilast RAPIHALER 100/3Symbicort Rapihaler 100/3
Budesonide with formoterol	GRP-27470	Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses	Inhalation by mouth	Cipla Budesonide + Formoterol 200/6Rilast RAPIHALER 200/6Symbicort Rapihaler 200/6
Buprenorphine	GRP-22238	Transdermal patch 10 mg	Transdermal	B-PatchBupredermalBuprenorphine SandozNorspan
Buprenorphine	GRP-22240	Transdermal patch 20 mg	Transdermal	B-PatchBupredermalBuprenorphine SandozNorspan
Buprenorphine	GRP-22242	Transdermal patch 5 mg	Transdermal	B-PatchBupredermalBuprenorphine SandozNorspan
Buprenorphine	GRP-22416	Transdermal patch 15 mg	Transdermal	B-PatchBupredermalBuprenorphine SandozNorspan
Buprenorphine	GRP-24240	Transdermal patch 25 mg	Transdermal	BupredermalBuprenorphine SandozNorspan
Buprenorphine	GRP-24242	Transdermal patch 30 mg	Transdermal	BupredermalBuprenorphine SandozNorspan
Buprenorphine	GRP-24244	Transdermal patch 40 mg	Transdermal	BupredermalBuprenorphine SandozNorspan
Cabergoline	GRP-1160	Tablet 500 micrograms	Oral	DostamineDostinex
Calcipotriol with betamethasone	GRP-21226	Ointment containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 30 g	Application	Calcipotriol/Betamethasone Sandoz 50/500Daivobet
Calcipotriol with betamethasone	GRP-28854	Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g	Application	EnstilarKlarvanta
Calcitriol	GRP-1016	Capsule 0.25 microgram	Oral	CalciproxCALITROLRocaltrolSical
Candesartan	GRP-13697	Tablet containing candesartan cilexetil 4 mg	Oral	AdesanAPO-CandesartanAtacandBTC CandesartanCANDESANCandesartan SandozCANDESARTAN-WGR
Candesartan	GRP-13700	Tablet containing candesartan cilexetil 8 mg	Oral	AdesanAPO-CandesartanAtacandBTC CandesartanCANDESANCandesartan SandozCANDESARTAN-WGR
Candesartan	GRP-13708	Tablet containing candesartan cilexetil 16 mg	Oral	AdesanAPO-CandesartanAtacandBTC CandesartanCANDESANCandesartan SandozCANDESARTAN-WGR
Candesartan	GRP-13710	Tablet containing candesartan cilexetil 32 mg	Oral	AdesanAPO-CandesartanAtacandBTC CandesartanCANDESANCandesartan SandozCANDESARTAN-WGR
Candesartan with hydrochlorothiazide	GRP-13507	Tablet containing candesartan cilexetil 16 mg with hydrochlorothiazide 12.5 mg	Oral	Adesan HCT 16/12.5APO-Candesartan HCTZ 16/12.5Atacand Plus 16/12.5BTC Candesartan HCTCANDESAN COMBI 16/12.5Candesartan/HCT SandozCANDESARTAN HCTZ-WGR 16/12.5
Candesartan with hydrochlorothiazide	GRP-13547	Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg	Oral	Adesan HCT 32/12.5APO-Candesartan HCTZ 32/12.5Atacand Plus 32/12.5BTC Candesartan HCTCANDESAN COMBI 32/12.5Candesartan/HCT SandozCANDESARTAN HCTZ-WGR 32/12.5
Candesartan with hydrochlorothiazide	GRP-13549	Tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg	Oral	Adesan HCT 32/25APO-Candesartan HCTZ 32/25Atacand Plus 32/25BTC Candesartan HCTCANDESAN COMBI 32/25Candesartan/HCT SandozCANDESARTAN HCTZ-WGR 32/25
Carbamazepine	GRP-1053	Tablet 100 mg	Oral	AVLOIRETegretol 100
Carbamazepine	GRP-1054	Tablet 200 mg	Oral	AVLOIRETegretol 200
Carbimazole	GRP-24049	Tablet 5 mg	Oral	Neo-MercazoleTHIRAZOLWP Carbimazole
Carbomer	GRP-1253	Eye gel 2 mg per g, 10 g	Application to the eye	Optifresh eye gelPAAViscotears
Carvedilol	GRP-1213	Tablet 12.5 mg	Oral	APO-CarvedilolCarvedilol SandozCARVEDILOL-WGRCarvidolDicarzDilatrend 12.5Vedilol 12.5Volirop 12.5
Carvedilol	GRP-1214	Tablet 25 mg	Oral	APO-CarvedilolCarvedilol SandozCARVEDILOL-WGRCarvidolDicarzDilatrend 25Vedilol 25Volirop 25
Carvedilol	GRP-1215	Tablet 3.125 mg	Oral	APO-CarvedilolCarvidolVedilol 3.125Volirop 3.125
Carvedilol	GRP-1216	Tablet 6.25 mg	Oral	APO-CarvedilolCarvedilol SandozCARVEDILOL-WGRCarvidolDicarzDilatrend 6.25Vedilol 6.25Volirop 6.25
Cefaclor	GRP-1070	Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL	Oral	CeclorCefaclor SUNKeflor
Cefaclor	GRP-1071	Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL	Oral	CeclorCefaclor SUNKeflor
Cefaclor	GRP-1072	Tablet (sustained release) 375 mg (as monohydrate)	Oral	Ceclor CDKeflor CD
Cefalexin	GRP-1111	Capsule 250 mg (as monohydrate)	Oral	APO-CephalexinCefalexin ViatrisIbilex 250Keflex
Cefalexin	GRP-1112	Capsule 500 mg (as monohydrate)	Oral	APO-CephalexinBlooms The Chemist CefalexinCefalexin SandozCephalex 500Cephalexin generichealthCEPHALEXIN-WGRIbilex 500Keflex
Cefalexin	GRP-1113	Granules for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL	Oral	Cefalexin SandozIbilex 125
Cefalexin	GRP-1114	Granules for oral suspension 250 mg (as monohydrate) per 5 mL, 100 mL	Oral	Cefalexin SandozIbilex 250Keflex
Ceftriaxone	GRP-1095	Powder for injection 2 g (as sodium)	Injection	Ceftriaxone Viatris
Cefuroxime	GRP-22619	Tablet 250 mg (as axetil)	Oral	ARX-CefuroximePharmacor CefuroximeZinnat
Celecoxib	GRP-15173	Capsule 100 mg	Oral	APX-CelecoxibBlooms CelecoxibCelaxibCelebrexCelecoxib GHCelecoxib SandozCELECOXIB-WGRCelexi
Celecoxib	GRP-15175	Capsule 200 mg	Oral	APX-CelecoxibBlooms CelecoxibCelaxibCelebrexCelecoxib GHCelecoxib SandozCELECOXIB-WGRCelexi
Choriogonadotropin alfa	GRP-29198	Solution for injection 250 micrograms in 0.5 mL pre-filled pen	Injection	Ovidrel
Choriogonadotropin alfa	GRP-29198	Solution for injection 250 micrograms in 0.5 mL pre-filled syringe (S19A)	Injection	Ovidrel (USA)
Ciclosporin	GRP-1048	Capsule 100 mg	Oral	APO-CiclosporinCICLOSPORIN-WGRNeoral 100
Ciclosporin	GRP-1049	Capsule 25 mg	Oral	APO-CiclosporinCICLOSPORIN-WGRNeoral 25
Ciclosporin	GRP-1050	Capsule 50 mg	Oral	APO-CiclosporinCICLOSPORIN-WGRNeoral 50
Cinacalcet	GRP-24610	Tablet 30 mg (as hydrochloride)	Oral	Cinacalcet ViatrisPharmacor Cinacalcet
Cinacalcet	GRP-24612	Tablet 60 mg (as hydrochloride)	Oral	Cinacalcet ViatrisPharmacor Cinacalcet
Cinacalcet	GRP-24614	Tablet 90 mg (as hydrochloride)	Oral	Cinacalcet ViatrisPharmacor Cinacalcet
Ciprofloxacin	GRP-1271	Eye drops 3 mg (as hydrochloride) per mL, 5 mL	Application to the eye	CiloQuinCiloxan
Ciprofloxacin	GRP-1272	Tablet 250 mg (as hydrochloride)	Oral	APO-CiprofloxacinC-Flox 250Ciprofloxacin SandozCIPROFLOXACIN-WGRCiprol 250
Ciprofloxacin	GRP-1273	Tablet 500 mg (as hydrochloride)	Oral	APO-CiprofloxacinC-Flox 500Ciprofloxacin SandozCIPROFLOXACIN-WGRCiprol 500
Ciprofloxacin	GRP-1274	Tablet 750 mg (as hydrochloride)	Oral	APO-CiprofloxacinC-Flox 750Ciprofloxacin SandozCIPROFLOXACIN-WGRCiprol 750
Citalopram	GRP-1200	Tablet 20 mg (as hydrobromide)	Oral	APO-CitalopramAPX-CitalopramCelapramCipramilCitalopram SandozCITALOPRAM-WGRTalam
Citalopram	GRP-1201	Tablet 40 mg (as hydrobromide)	Oral	APO-CitalopramCelapramCitalopram SandozCITALOPRAM-WGRTalam
Citalopram	GRP-12767	Tablet 10 mg (as hydrobromide)	Oral	CelapramCITALOPRAM-WGRTalam
Cladribine	GRP-30338	Tablet 10 mg	Oral	CLADRITABMavenclad
Cladribine	GRP-30340	Tablet 10 mg	Oral	CLADRITABMavenclad
Cladribine	GRP-30342	Tablet 10 mg	Oral	CLADRITABMavenclad
Clarithromycin	GRP-1122	Tablet 250 mg	Oral	Clarithro 250Clarithromycin SandozKalixocinKlacid
Clindamycin	GRP-671	Capsule 150 mg (as hydrochloride)	Oral	APO-ClindamycinCalindaminClindamycin LUCLINDAMYCIN-WGRClindamykDalacin C
Clomipramine	GRP-685	Tablet containing clomipramine hydrochloride 25 mg	Oral	Anafranil 25APO-ClomipramineCLOMIPRAMINE-WGRPlacil
Clonazepam	GRP-690	Tablet 500 micrograms	Oral	Paxam 0.5Rivotril
Clonidine	GRP-21272	Tablet containing clonidine hydrochloride 100 micrograms	Oral	APO-ClonidineCatapres 100Clonidine Lupin
Clopidogrel	GRP-1244	Tablet 75 mg (as besilate)	Oral	CLOPIDOGREL-WGRClovix 75Plidogrel
Clopidogrel	GRP-1244	Tablet 75 mg (as hydrogen sulfate)	Oral	Blooms ClopidogrelClopidogrel LupinClopidogrel Sandoz PharmaClopidogrel WinthropIscoverPiaxPlavicor 75
Clopidogrel with aspirin	GRP-724	Tablet 75 mg (as hydrogen sulfate)-100 mg	Oral	APX-Clopidogrel/Aspirin 75/100DuoCoverDuoPlidogrelPiax Plus Aspirin
Codeine with paracetamol	GRP-697	Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg	Oral	APO- Paracetamol/Codeine 500/30APX-Paracetamol/CodeineCodalgin ForteCodapane Forte 500/30Comfarol FortePanadeine ForteParacetamol/Codeine GH 500/30Prodeine Forte
Colchicine	GRP-699	Tablet 500 micrograms	Oral	ARX-ColchicineCOLCHICINE-WGRColcineColgoutLengout
Cyproterone	GRP-721	Tablet containing cyproterone acetate 100 mg	Oral	Androcur-100ANTERONE 100Cyproterone Sandoz
Cyproterone	GRP-722	Tablet containing cyproterone acetate 50 mg	Oral	ANTERONE 50Cyproterone Sandoz
Cyproterone	GRP-723	Tablet containing cyproterone acetate 50 mg	Oral	AndrocurANTERONE 50Cyproterone Sandoz
Dabigatran etexilate	GRP-27945	Capsule 110 mg (as mesilate)	Oral	ARX-DabigatranDabigatran SandozDabigatran ViatrisPHARMACOR DABIGATRANPradaxa
Dabigatran etexilate	GRP-27948	Capsule 150 mg (as mesilate)	Oral	ARX-DabigatranDabigatran SandozDabigatran ViatrisPHARMACOR DABIGATRANPradaxa
Dabigatran etexilate	GRP-27952	Capsule 75 mg (as mesilate)	Oral	ARX-DabigatranDabigatran ViatrisPHARMACOR DABIGATRANPradaxa
Dapsone	GRP-29343	Tablet 100 mg	Oral	DAPSOMEDLink Medical Products Pty Ltd
Dapsone	GRP-31100	Tablet 25 mg	Oral	Link Medical Products Pty Ltd
Dapsone	GRP-31100	Tablet 25 mg (s19A)	Oral	Dapsone Tablets, USP 25 mg (Rising Pharmaceuticals, USA)
Darunavir	GRP-24110	Tablet 600 mg	Oral	Darunavir Juno
Darunavir	GRP-24110	Tablet 600 mg (as ethanolate)	Oral	Prezista
Darunavir	GRP-25529	Tablet 800 mg	Oral	Darunavir Juno
Darunavir	GRP-25529	Tablet 800 mg (as ethanolate)	Oral	Prezista
Dasatinib	GRP-25711	Tablet 100 mg	Oral	Dasatinib ARXDasatinib Dr.Reddy'sDasatinib SandozDasatinib SUNDASATINIB-TEVADasatinib ViatrisSprycel
Dasatinib	GRP-25721	Tablet 20 mg	Oral	Dasatinib ARXDasatinib Dr.Reddy'sDasatinib SandozDasatinib SUNDASATINIB-TEVADasatinib ViatrisSprycel
Dasatinib	GRP-25723	Tablet 50 mg	Oral	Dasatinib ARXDasatinib Dr.Reddy'sDasatinib SandozDasatinib SUNDASATINIB-TEVADasatinib ViatrisSprycel
Dasatinib	GRP-25725	Tablet 70 mg	Oral	Dasatinib ARXDasatinib Dr.Reddy'sDasatinib SandozDasatinib SUNDASATINIB-TEVADasatinib ViatrisSprycel
Deferasirox	GRP-25306	Tablet 180 mg	Oral	DEFERAMEDDeferasirox ARXDeferasirox SandozDEFERASIROX-TEVAEferasJadenuPharmacor Deferasirox FC
Deferasirox	GRP-25308	Tablet 360 mg	Oral	DEFERAMEDDeferasirox ARXDeferasirox SandozDEFERASIROX-TEVAEferasJadenuPharmacor Deferasirox FC
Deferasirox	GRP-25310	Tablet 90 mg	Oral	DEFERAMEDDeferasirox ARXDeferasirox SandozDEFERASIROX-TEVAEferasJadenuPharmacor Deferasirox FC
Deferasirox	GRP-28108	Tablet, dispersible, 500 mg	Oral	Deferasirox JunoPharmacor Deferasirox
Denosumab	GRP-29689	Injection 60 mg in 1 mL pre-filled syringe	Injection	CORORAJubbontiProliaStoboclo
Denosumab	GRP-29690	Injection 120 mg in 1.7 mL	Injection	GANVADOOsenveltWyostXgeva
Desmopressin	GRP-24618	Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL	Nasal	Desmomed
Desmopressin	GRP-24618	Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL	Nasal	Minirin Nasal Spray
Desmopressin	GRP-30583	Tablet (sublingual) 120 micrograms (as acetate)	Sublingual	Desmopressin ADVZ
Desmopressin	GRP-30583	Wafer 120 micrograms (as acetate)	Sublingual	Minirin Melt
Desmopressin	GRP-30585	Tablet (sublingual) 240 micrograms (as acetate)	Sublingual	Desmopressin ADVZ
Desmopressin	GRP-30585	Wafer 240 micrograms (as acetate)	Sublingual	Minirin Melt
Desvenlafaxine	GRP-16177	Tablet (extended release) 50 mg (as succinate)	Oral	Pristiq
Desvenlafaxine	GRP-16177	Tablet (modified release) 50 mg	Oral	BTC DesvenlafaxineDesfaxDESVENDesvenlafaxine SandozDesvenlafaxine Sandoz PharmaDesvenlafaxine ViatrisDESVENLAFAXINE-WGR XR
Desvenlafaxine	GRP-16177	Tablet (modified release) 50 mg (as benzoate)	Oral	APO-Desvenlafaxine MRDesvenlafaxine GH XR
Desvenlafaxine	GRP-16179	Tablet (extended release) 100 mg (as succinate)	Oral	Pristiq
Desvenlafaxine	GRP-16179	Tablet (modified release) 100 mg	Oral	BTC DesvenlafaxineDesfaxDESVENDesvenlafaxine SandozDesvenlafaxine Sandoz PharmaDesvenlafaxine ViatrisDESVENLAFAXINE-WGR XR
Desvenlafaxine	GRP-16179	Tablet (modified release) 100 mg (as benzoate)	Oral	APO-Desvenlafaxine MRDesvenlafaxine GH XR
Dexamethasone with framycetin and gramicidin	GRP-730	Ear drops containing dexamethasone 500 micrograms (as sodium metasulfobenzoate), framycetin sulfate 5 mg and gramicidin 50 micrograms per mL, 8 mL	Application to the ear	OtodexSofradex
Diazepam	GRP-731	Tablet 2 mg	Oral	Antenex 2APX-DiazepamDIAZEPAM-WGRValpam 2
Diazepam	GRP-732	Tablet 5 mg	Oral	Antenex 5APX-DiazepamDIAZEPAM-WGRValiumValpam 5
Diclofenac	GRP-733	Tablet (enteric coated) containing diclofenac sodium 25 mg	Oral	Clonac 25Diclofenac SandozDICLOFENAC-WGRFenac ECVoltaren 25
Diclofenac	GRP-734	Tablet (enteric coated) containing diclofenac sodium 50 mg	Oral	Clonac 50Diclofenac SandozDICLOFENAC-WGRFenac ECVoltaren 50
Dicloxacillin	GRP-1162	Capsule 500 mg (as sodium)	Oral	ARX-DicloxacillinDICLOXACILLIN VIATRIS 500Distaph 500
Dicloxacillin	GRP-22250	Capsule 250 mg (as sodium)	Oral	ARX-DicloxacillinDICLOXACILLIN VIATRIS 250Distaph 250
Dienogest	GRP-29688	Tablet 2 mg	Oral	DinasaneVisanne
Digoxin	GRP-735	Tablet 250 micrograms	Oral	LanoxinSigmaxin
Digoxin	GRP-736	Tablet 62.5 micrograms	Oral	Lanoxin-PGSigmaxin-PG
Diltiazem	GRP-737	Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg	Oral	Cardizem CDDiltiazem Sandoz CDVasocardol CD
Diltiazem	GRP-738	Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg	Oral	Cardizem CDDiltiazem Sandoz CDVasocardol CD
Diltiazem	GRP-739	Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg	Oral	Diltiazem Sandoz CDVasocardol CD
Diltiazem	GRP-740	Tablet containing diltiazem hydrochloride 60 mg	Oral	CardizemVasocardol
Dimethyl fumarate	GRP-26007	Capsule (modified release) 120 mg	Oral	APO-DIMETHYL FUMARATEDimethyl Fumarate SandozPharmacor Dimethyl FumarateTecfidera
Dimethyl fumarate	GRP-26009	Capsule (modified release) 240 mg	Oral	APO-DIMETHYL FUMARATEDimethyl Fumarate SandozPharmacor Dimethyl FumarateTecfideraTrazent
Diphenoxylate with atropine	GRP-741	Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate monohydrate 25 micrograms	Oral	LofenoxalLomotil
Disopyramide	GRP-27352	Capsule 100 mg	Oral	Rythmodan
Disopyramide	GRP-27352	Capsule 100 mg (Japan) (s19A)	Oral	Rythmodan (Japan)
Disopyramide	GRP-27352	Capsule 100 mg (s19A)	Oral	Rythmodan (UK)
Domperidone	GRP-26868	Tablet 10 mg	Oral	APO-DOMPERIDONEMotilium
Donepezil	GRP-12632	Tablet containing donepezil hydrochloride 10 mg	Oral	APO-DonepezilArazilAriceptAridon 10Aridon APN 10Donepezil GHDonepezil SandozDONEPEZIL-WGR
Donepezil	GRP-12634	Tablet containing donepezil hydrochloride 5 mg	Oral	APO-DonepezilArazilAriceptAridon 5Aridon APN 5Donepezil GHDonepezil SandozDONEPEZIL-WGR
Dorzolamide	GRP-15332	Eye drops 20 mg (as hydrochloride) per mL, 5 mL	Application to the eye	TrusamideTrusopt
Dorzolamide with timolol	GRP-15180	Eye drops containing dorzolamide 20 mg (as hydrochloride) with timolol 5 mg (as maleate) per mL, 5 mL	Application to the eye	CosdorCosoptVizo-PF Dorzolatim
Dosulepin	GRP-22220	Capsule containing dosulepin hydrochloride 25 mg	Oral	Dosulepin ViatrisDothep 25
Dosulepin	GRP-22224	Tablet containing dosulepin hydrochloride 75 mg	Oral	Dosulepin Viatris 75Dothep 75
Doxorubicin - pegylated liposomal	GRP-14338	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	CaelyxLiposomal Doxorubicin SUN
Doxycycline	GRP-1300	Capsule 100 mg (as hyclate) (containing enteric coated pellets)	Oral	DoryxMayne Pharma Doxycycline
Doxycycline	GRP-1300	Tablet 100 mg (as hyclate)	Oral	APX-DoxycyclineDoxsigDOXYCYCLINE-WGRDoxylin 100
Doxycycline	GRP-1300	Tablet 100 mg (as monohydrate)	Oral	Blooms The Chemist DoxycyclineDoxycycline Sandoz
Doxycycline	GRP-1301	Capsule 50 mg (as hyclate) (containing enteric coated pellets)	Oral	DoryxMayne Pharma Doxycycline
Doxycycline	GRP-1301	Tablet 50 mg (as hyclate)	Oral	APX-DoxycyclineDoxsigDOXYCYCLINE-WGRDoxylin 50
Doxycycline	GRP-1301	Tablet 50 mg (as monohydrate)	Oral	Doxycycline Sandoz
Drospirenone	GRP-29787	Pack containing 24 tablets 4 mg and 4 inert tablets	Oral	LucindaSlinda
Drospirenone with ethinylestradiol	GRP-29804	Pack containing 21 tablets 3 mg drospirenone with 30 micrograms ethinylestradiol and 7 inert tablets	Oral	BrooklynnIsabelleMilaRosaleeYasminYelena
Drospirenone with ethinylestradiol	GRP-29806	Pack containing 21 tablets 3 mg drospirenone with 30 micrograms ethinylestradiol and 7 inert tablets	Oral	BrooklynnIsabelleMilaRosaleeYasminYelena
Drospirenone with ethinylestradiol	GRP-29810	Pack containing 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol and 4 inert tablets	Oral	BellaBrookeRosieYANA
Drospirenone with ethinylestradiol	GRP-29810	Pack containing 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol (as betadex clathrate) and 4 inert tablets	Oral	Yaz
Drospirenone with ethinylestradiol	GRP-29812	Pack containing 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol and 4 inert tablets	Oral	BellaBrookeRosieYANA
Drospirenone with ethinylestradiol	GRP-29812	Pack containing 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol (as betadex clathrate) and 4 inert tablets	Oral	Yaz
Duloxetine	GRP-12613	Capsule 60 mg (as hydrochloride)	Oral	APO-DuloxetineBlooms The Chemist DuloxetineDuloxecorDuloxetine SandozDuloxetine Sandoz 60DULOXETINE-WGRDYTREX 60Tixol 60
Duloxetine	GRP-12614	Capsule 30 mg (as hydrochloride)	Oral	APO-DuloxetineBlooms The Chemist DuloxetineDuloxecorDuloxetine SandozDuloxetine Sandoz 30DULOXETINE-WGRDYTREX 30Tixol 30
Dupilumab	GRP-29909	Injection 200 mg in 1.14 mL single dose pre-filled pen	Injection	Dupixent
Dupilumab	GRP-29909	Injection 200 mg in 1.14 mL single dose pre-filled syringe	Injection	Dupixent
Dupilumab	GRP-29910	Injection 300 mg in 2 mL single dose pre-filled pen	Injection	Dupixent
Dupilumab	GRP-29910	Injection 300 mg in 2 mL single dose pre-filled syringe	Injection	Dupixent
Dutasteride	GRP-21807	Capsule 500 micrograms	Oral	APO-DutasterideAvodartDutacor
Dutasteride with tamsulosin	GRP-23940	Capsule containing dutasteride 500 micrograms with tamsulosin hydrochloride 400 micrograms	Oral	DoublutsDuodart 500ug/400ugDutasteride/Tamsulosin Lupin 500/400Dutasteride/Tamsulosin Sandoz 500/400Dutasteride/Tamsulosin Viatris 500/40DUTASTERIDE/TAMSULOSIN-WGRDUTASTERIDE-TAMSULOSIN ZPLDUTATAM 500/400
Enalapril	GRP-752	Tablet containing enalapril maleate 10 mg	Oral	AcetecAPO-EnalaprilEnalapril SandozENALAPRIL-WGRMaleanRenitec
Enalapril	GRP-753	Tablet containing enalapril maleate 20 mg	Oral	AcetecAPO-EnalaprilEnalapril SandozENALAPRIL-WGRMaleanRenitec 20
Enalapril	GRP-754	Tablet containing enalapril maleate 5 mg	Oral	AcetecAPO-EnalaprilEnalapril SandozENALAPRIL-WGRMalean
Enalapril with hydrochlorothiazide	GRP-1286	Tablet containing enalapril maleate 20 mg with hydrochlorothiazide 6 mg	Oral	Enalapril/HCT SandozRenitec Plus 20/6
Enoxaparin	GRP-21948	Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe	Injection	Clexane Safety-LockEnoxaject Safety-LockExaraneExarane Safety-Lock
Enoxaparin	GRP-21950	Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe	Injection	Clexane Safety-LockEnoxaject Safety-LockExaraneExarane Safety-Lock
Enoxaparin	GRP-21958	Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe	Injection	Clexane Safety-LockEnoxaject Safety-LockExaraneExarane Safety-Lock
Enoxaparin	GRP-21960	Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe	Injection	Clexane Safety-LockEnoxaject Safety-LockExaraneExarane Safety-Lock
Enoxaparin	GRP-21962	Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe	Injection	Clexane Safety-LockEnoxaject Safety-LockExaraneExarane Safety-Lock
Enoxaparin	GRP-27957	Injection containing enoxaparin sodium 120 mg (12,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe	Injection	Clexane Forte Safety-LockEnoxaject Safety-LockExarane ForteExarane Forte Safety-Lock
Enoxaparin	GRP-27959	Injection containing enoxaparin sodium 150 mg (15,000 I.U. anti-Xa) in 1 mL pre-filled syringe	Injection	Clexane Forte Safety-LockEnoxaject Safety-LockExarane ForteExarane Forte Safety-Lock
Entecavir	GRP-21110	Tablet 0.5 mg (as monohydrate)	Oral	ENTACENTECAVIR APOEntecavir GHENTECAVIR RBXEntecavir SandozEntecavir ViatrisENTECAVIR-WGR
Entecavir	GRP-21112	Tablet 1 mg (as monohydrate)	Oral	ENTECAVIR APOENTECAVIR RBXEntecavir SandozEntecavir ViatrisENTECAVIR-WGR
Eplerenone	GRP-20663	Tablet 25 mg	Oral	APO-EplerenoneESPLERInplerInspra
Eplerenone	GRP-20665	Tablet 50 mg	Oral	APO-EplerenoneESPLERInplerInspra
Erlotinib	GRP-24728	Tablet 100 mg (as hydrochloride)	Oral	ERLOTINIB ARXErlotinib Sandoz
Erlotinib	GRP-24730	Tablet 150 mg (as hydrochloride)	Oral	ERLOTINIB ARXErlotinib Sandoz
Erlotinib	GRP-24732	Tablet 25 mg (as hydrochloride)	Oral	ERLOTINIB ARXErlotinib Sandoz
Escitalopram	GRP-694	Tablet 10 mg (as oxalate)	Oral	APO-EscitalopramAPX-EscitalopramBlooms EscitalopramCilopam-SESCITEscitalopram GHEscitalopram SandozESCITALOPRAM-WGRLexam 10LexaproLoxaLate
Escitalopram	GRP-695	Tablet 20 mg (as oxalate)	Oral	APO-EscitalopramAPX-EscitalopramBlooms EscitalopramCilopam-SESCITEscitalopram GHEscitalopram SandozESCITALOPRAM-WGRLexam 20LexaproLoxaLate
Esomeprazole	GRP-14755	Capsule (enteric) 20 mg (as magnesium)	Oral	Noxicid Caps
Esomeprazole	GRP-14755	Tablet (enteric coated) 20 mg (as magnesium)	Oral	APO-EsomeprazoleEsomeprazole GHEsomeprazole GxPEsomeprazole RBXEsomeprazole ViatrisESOMEPRAZOLE-WGREsoprezeNexazoleNexiumNexole
Esomeprazole	GRP-14756	Capsule (enteric) 40 mg (as magnesium)	Oral	Noxicid Caps
Esomeprazole	GRP-14756	Tablet (enteric coated) 40 mg (as magnesium)	Oral	APO-EsomeprazoleEsomeprazole GHEsomeprazole GxPEsomeprazole RBXEsomeprazole ViatrisESOMEPRAZOLE-WGREsoprezeNexazoleNexiumNexole
Esomeprazole and clarithromycin and amoxicillin	GRP-20622	Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate)	Oral	ESOMEPRAZOLE SANDOZ Hp7
Esomeprazole and clarithromycin and amoxicillin	GRP-20622	Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate)	Oral	Nexium Hp7
Estradiol	GRP-27166	Pessary (modified release) 10 micrograms (as hemihydrate)	Vaginal	Estro-PessVagifem Low
Estradiol	GRP-31220	Transdermal patches 390 micrograms, 8	Transdermal	Estradot 25
Estradiol	GRP-31220	Transdermal patches 390 micrograms, 8 (s19A)	Transdermal	Dermestril 25 (Italy)
Estradiol	GRP-31221	Transdermal patches 780 micrograms, 8	Transdermal	Estradot 50
Estradiol	GRP-31221	Transdermal patches 780 micrograms, 8 (s19A)	Transdermal	Dermestril 50 (Italy)
Etanercept	GRP-21348	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	BrenzysEnbrelErelziNepexto
Etanercept	GRP-21348	Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	BrenzysEnbrelErelzi
Everolimus	GRP-25247	Tablet 1 mg	Oral	CerticanEverocan
Everolimus	GRP-25249	Tablet 0.25 mg	Oral	CerticanEverocan
Everolimus	GRP-25251	Tablet 0.5 mg	Oral	CerticanEverocan
Everolimus	GRP-25253	Tablet 0.75 mg	Oral	CerticanEverocan
Exemestane	GRP-1292	Tablet 25 mg	Oral	APO-ExemestaneAromasinExemestane GHExemestane SandozEXEMESTANE-WGR
Ezetimibe	GRP-22269	Tablet 10 mg	Oral	APO-EzetimibeARX-EZETIMIBEBTC EzetimibeEZEMICHOLEzetimibe GHEzetimibe SandozEZETIMIBE-WGREzetrolPharmacor Ezetimibe 10Zient 10mg
Ezetimibe and rosuvastatin	GRP-22271	Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium)	Oral	Ezalo Composite Pack 10mg+10mgEzetimibe - Rosuvastatin Sandoz 10 mg/10 mgPharmacor Ezetimibe Rosuvastatin Composite PackRosuzet Composite Pack
Ezetimibe and rosuvastatin	GRP-22273	Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium)	Oral	Ezalo Composite Pack 10mg+20mgEzetimibe - Rosuvastatin Sandoz 10 mg/20 mgPharmacor Ezetimibe Rosuvastatin Composite PackRosuzet Composite Pack
Ezetimibe and rosuvastatin	GRP-22275	Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium)	Oral	Ezalo Composite Pack 10mg+40mgEzetimibe - Rosuvastatin Sandoz 10 mg/40 mgPharmacor Ezetimibe Rosuvastatin Composite PackRosuzet Composite Pack
Ezetimibe and rosuvastatin	GRP-22277	Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium)	Oral	Ezalo Composite Pack 10mg+5mgEzetimibe - Rosuvastatin Sandoz 10 mg/5 mgRosuzet Composite Pack
Ezetimibe with atorvastatin	GRP-23656	Tablet 10 mg-10 mg	Oral	AtozetEzetastEzetimibe/Atorvastatin GH 10/10
Ezetimibe with atorvastatin	GRP-23658	Tablet 10 mg-20 mg	Oral	AtozetEzetastEzetimibe/Atorvastatin GH 10/20
Ezetimibe with atorvastatin	GRP-23661	Tablet 10 mg-40 mg	Oral	AtozetEzetastEzetimibe/Atorvastatin GH 10/40
Ezetimibe with atorvastatin	GRP-23663	Tablet 10 mg-80 mg	Oral	AtozetEzetastEzetimibe/Atorvastatin GH 10/80
Ezetimibe with simvastatin	GRP-22279	Tablet 10 mg-10 mg	Oral	APO-Ezetimibe/Simvastatin 10/10EZETIMIBE/SIMVASTATIN SANDOZEZETIMIBE/SIMVASTATIN-WGR 10/10EZETORINPharmacor Ezetimibe Simvastatin 10/10VytorinZimybe 10/10
Ezetimibe with simvastatin	GRP-22281	Tablet 10 mg-20 mg	Oral	APO-Ezetimibe/Simvastatin 10/20EZETIMIBE/SIMVASTATIN SANDOZEZETIMIBE/SIMVASTATIN-WGR 10/20EZETORINPharmacor Ezetimibe Simvastatin 10/20VytorinZimybe 10/20
Ezetimibe with simvastatin	GRP-22283	Tablet 10 mg-40 mg	Oral	APO-Ezetimibe/Simvastatin 10/40EZETIMIBE/SIMVASTATIN SANDOZEZETIMIBE/SIMVASTATIN-WGR 10/40EZETORINPharmacor Ezetimibe Simvastatin 10/40VytorinZimybe 10/40
Ezetimibe with simvastatin	GRP-22285	Tablet 10 mg-80 mg	Oral	APO-Ezetimibe/Simvastatin 10/80EZETIMIBE/SIMVASTATIN SANDOZEZETIMIBE/SIMVASTATIN-WGR 10/80EZETORINPharmacor Ezetimibe Simvastatin 10/80VytorinZimybe 10/80
Famciclovir	GRP-1105	Tablet 125 mg	Oral	APO-FamciclovirFamvirFavic 125
Famciclovir	GRP-1106	Tablet 250 mg	Oral	APO-FamciclovirFAMCICLOVIR-WGRFamvirFavic 250
Famciclovir	GRP-1107	Tablet 250 mg	Oral	APO-FamciclovirEzovirFAMCICLOVIR-WGRFamvirFavic 250
Famciclovir	GRP-1108	Tablet 250 mg	Oral	APO-FamciclovirEzovirFAMCICLOVIR-WGRFamvirFavic 250
Famciclovir	GRP-1109	Tablet 500 mg	Oral	APO-FamciclovirFAMCICLOVIR-WGRFamvirFavic 500
Famciclovir	GRP-1110	Tablet 500 mg	Oral	APO-FamciclovirEzovirFAMCICLOVIR-WGRFamvirFavic 500
Faricimab	GRP-29393	Solution for intravitreal injection 21 mg in 0.175 mL (120 mg per mL) pre-filled syringe	Injection	Vabysmo
Faricimab	GRP-29393	Solution for intravitreal injection 28.8 mg in 0.24 mL (120 mg per mL)	Injection	Vabysmo
Febuxostat	GRP-30722	Tablet 80 mg	Oral	AdenuricFebexic
Felodipine	GRP-767	Tablet 10 mg (extended release)	Oral	Felodil XR 10Felodur ER 10 mgPlendil ER
Felodipine	GRP-768	Tablet 2.5 mg (extended release)	Oral	Felodil XR 2.5Felodur ER 2.5 mgPlendil ER
Felodipine	GRP-769	Tablet 5 mg (extended release)	Oral	Felodil XR 5Felodur ER 5 mgPlendil ER
Fenofibrate	GRP-20649	Tablet 48 mg	Oral	APO-FenofibrateARX-FENOFIBRATEFenofibrate LupinFENOFIBRATE RBXFenofibrate ViatrisFENOFIBRATE-WGRLipidil
Fenofibrate	GRP-20651	Tablet 145 mg	Oral	APO-FenofibrateARX-FENOFIBRATEBTC FenofibrateFenocolFenofibrate CiplaFenofibrate LupinFENOFIBRATE RBXFenofibrate SandozFenofibrate ViatrisFENOFIBRATE-WGRLipidil
Fentanyl	GRP-1228	Transdermal patch 12.6 mg	Transdermal	APO-FentanylFentanyl Sandoz
Fentanyl	GRP-1230	Transdermal patch 16.8 mg	Transdermal	APO-FentanylFentanyl Sandoz
Fentanyl	GRP-1232	Transdermal patch 2.1 mg	Transdermal	APO-FentanylFentanyl Sandoz
Fentanyl	GRP-1235	Transdermal patch 4.2 mg	Transdermal	APO-FentanylFentanyl Sandoz
Fentanyl	GRP-1239	Transdermal patch 8.4 mg	Transdermal	APO-FentanylFentanyl Sandoz
Ferric carboxymaltose	GRP-30702	Injection 1000 mg (iron) in 20 mL	Injection	FerinjectFERIVOFERRICARBOFerric Carboxymaltose-TevaFerrive
Ferric carboxymaltose	GRP-30704	Injection 500 mg (iron) in 10 mL	Injection	FerinjectFERIVOFERRICARBOFerric Carboxymaltose-TevaFerrive
Filgrastim	GRP-23317	Injection 480 micrograms in 0.5 mL single-use pre-filled syringe	Injection	NivestimZarzio
Filgrastim	GRP-23321	Injection 300 micrograms in 0.5 mL single-use pre-filled syringe	Injection	NivestimZarzio
Fingolimod	GRP-26729	Capsule 500 micrograms (as hydrochloride)	Oral	AKM FingolimodFILOSIRFingolimod Dr.Reddy'sFingolimod SandozFingolimod SUNFingolimod-TevaFynodGilenyaPharmacor Fingolimod
Flecainide	GRP-770	Tablet containing flecainide acetate 100 mg	Oral	APO-FlecainideFlecainide SandozFlecatabTambocor
Flecainide	GRP-20661	Tablet containing flecainide acetate 50 mg	Oral	APO-FlecainideFlecainide SandozFlecatabTambocor
Flucloxacillin	GRP-771	Capsule 250 mg (as sodium monohydrate)	Oral	FlopenFlopen ViatrisStaphylex 250
Flucloxacillin	GRP-772	Capsule 500 mg (as sodium monohydrate)	Oral	FlopenFlopen ViatrisStaphylex 500
Fluconazole	GRP-1017	Capsule 100 mg	Oral	DiflucanDizole 100Fluconazole SandozOzole
Fluconazole	GRP-1018	Capsule 200 mg	Oral	APO-FluconazoleDiflucanDizole 200Fluconazole SandozFLUCONAZOLE-WGRFluzole 200Ozole
Fluconazole	GRP-1019	Capsule 50 mg	Oral	DiflucanDizole 50Fluconazole SandozOzole
Fludrocortisone	GRP-25933	Tablet containing fludrocortisone acetate 100 micrograms	Oral	FlorinefFLUDROCORTISONE MEDSURGE
Fluoxetine	GRP-778	Capsule 20 mg (as hydrochloride)	Oral	APO-FluoxetineBlooms the Chemist FluoxetineFLUOTEXFluoxetine generichealthFluoxetine SandozFLUOXETINE-WGRZactin
Fluticasone propionate	GRP-21474	Pressurised inhalation containing fluticasone propionate 125 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	AxotideFlixotideFluticasone Cipla Inhaler
Fluticasone propionate	GRP-21476	Pressurised inhalation containing fluticasone propionate 250 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	AxotideFlixotideFluticasone Cipla Inhaler
Fluticasone propionate	GRP-24652	Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms per dose, 60 doses	Inhalation by mouth	Axotide AccuhalerFlixotide Accuhaler
Fluticasone propionate	GRP-24656	Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms per dose, 60 doses	Inhalation by mouth	Axotide Junior AccuhalerFlixotide Junior Accuhaler
Fluticasone propionate	GRP-24658	Pressurised inhalation containing fluticasone propionate 50 micrograms per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	Axotide JuniorFlixotide Junior
Fluticasone propionate with salmeterol	GRP-21470	Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	Evocair MDIFluticasone + Salmeterol Cipla 125/25PavtideSalplusF Inhaler 125/25Seretide MDI 125/25
Fluticasone propionate with salmeterol	GRP-21472	Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	Evocair MDIFluticasone + Salmeterol Cipla 250/25PavtideSalplusF Inhaler 250/25Seretide MDI 250/25
Fluticasone propionate with salmeterol	GRP-24710	Powder for oral inhalation in breath actuated device containing fluticasone propionate 100 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses	Inhalation by mouth	PAVTIDE ACCUHALER 100/50Seretide Accuhaler 100/50
Fluticasone propionate with salmeterol	GRP-24712	Powder for oral inhalation in breath actuated device containing fluticasone propionate 250 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses	Inhalation by mouth	Fluticasone Salmeterol Ciphaler 250/50PAVTIDE ACCUHALER 250/50Salflumix Easyhaler 250/50SalplusF DPI 250/50Seretide Accuhaler 250/50
Fluticasone propionate with salmeterol	GRP-24714	Powder for oral inhalation in breath actuated device containing fluticasone propionate 500 micrograms with salmeterol 50 micrograms (as xinafoate) per dose, 60 doses	Inhalation by mouth	Fluticasone Salmeterol Ciphaler 500/50PAVTIDE ACCUHALER 500/50Salflumix Easyhaler 500/50SalplusF DPI 500/50Seretide Accuhaler 500/50
Fluticasone propionate with salmeterol	GRP-24717	Pressurised inhalation containing fluticasone propionate 50 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)	Inhalation by mouth	PAVTIDE MDI 50/25Seretide MDI 50/25
Fluvoxamine	GRP-1169	Tablet containing fluvoxamine maleate 100 mg	Oral	APO-FluvoxamineFaverin 100FLUVOXAMINE-WGRLuvoxMovox 100
Fluvoxamine	GRP-1170	Tablet containing fluvoxamine maleate 50 mg	Oral	APO-FluvoxamineFaverin 50FLUVOXAMINE-WGRLuvoxMovox 50
Folic acid	GRP-12687	Tablet 500 micrograms	Oral	Foltabs 500Megafol 0.5
Folinic acid	GRP-1031	Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL	Injection	CALCIUM FOLINATE MEDSURGEDBL Leucovorin Calcium
Follitropin alfa	GRP-25763	Injection 300 I.U. in 0.5 mL multi-dose cartridge	Injection	Gonal-f PenOvaleap
Follitropin alfa	GRP-25787	Injection 450 I.U. in 0.75 mL multi-dose cartridge	Injection	Gonal-f PenOvaleap
Follitropin alfa	GRP-25790	Injection 900 I.U. in 1.5 mL multi-dose cartridge	Injection	Gonal-f PenOvaleap
Fosaprepitant	GRP-27326	Powder for I.V. infusion 150 mg	Injection	FOSAPREPITANT-AFTFOSAPREPITANT MEDSURGEFOSAPREPITANT MSN
Fosinopril	GRP-1001	Tablet containing fosinopril sodium 10 mg	Oral	APO-FosinoprilMonace 10
Fosinopril	GRP-1002	Tablet containing fosinopril sodium 20 mg	Oral	APO-FosinoprilMonace 20
Fremanezumab	GRP-26607	Solution for injection 225 mg in 1.5 mL single dose pre-filled pen	Injection	Ajovy
Fremanezumab	GRP-26607	Solution for injection 225 mg in 1.5 mL single dose pre-filled syringe	Injection	Ajovy
Fulvestrant	GRP-25626	Injection 250 mg in 5 mL pre-filled syringe	Injection	FULVESTRANT ACCORDFULVESTRANT-AFTFULVESTRANT EVER PHARMAFulvestrant SandozFulvestrant SXP
Furosemide	GRP-781	Tablet 20 mg	Oral	APO-FrusemideFrusemix-MFUROSEMIDE-WGRUREMIDE 20
Furosemide	GRP-782	Tablet 40 mg	Oral	APO-FrusemideFrusaxFrusemixFUROSEMIDE-WGRUremide
Gabapentin	GRP-1077	Capsule 100 mg	Oral	APX-GabapentinGabacorGAPENTINNeurontinNupentin 100
Gabapentin	GRP-1078	Capsule 300 mg	Oral	APX-GabapentinGabacorGabapentin SandozGABAPENTIN-WGRGAPENTINNeurontinNupentin 300
Gabapentin	GRP-1079	Capsule 400 mg	Oral	APX-GabapentinGabacorGabapentin SandozGABAPENTIN-WGRGAPENTINNeurontinNupentin 400
Gabapentin	GRP-1080	Tablet 600 mg	Oral	APX-GABAPENTINGAPENTINNeurontinPharmacor Gabapentin 600
Gabapentin	GRP-1081	Tablet 800 mg	Oral	APX-GABAPENTINGAPENTINNeurontinPharmacor Gabapentin 800
Galantamine	GRP-663	Capsule (prolonged release) 16 mg (as hydrobromide)	Oral	APO-Galantamine MRGalantylGamine XRReminyl
Galantamine	GRP-664	Capsule (prolonged release) 24 mg (as hydrobromide)	Oral	APO-Galantamine MRGalantylGamine XRReminyl
Galantamine	GRP-665	Capsule (prolonged release) 8 mg (as hydrobromide)	Oral	APO-Galantamine MRGalantylGamine XRReminyl
Ganciclovir	GRP-22040	Powder for I.V. infusion 500 mg (as sodium)	Injection	CymeveneGANCICLOVIR SXP
Ganirelix	GRP-24666	Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe	Injection	ARX GanirelixGanirelix LupinGANIRELIX SUNOrgalutran
Ganirelix	GRP-24668	Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe	Injection	ARX GanirelixGanirelix LupinGANIRELIX SUNGanirelix TheramexOrgalutran
Gemfibrozil	GRP-783	Tablet 600 mg	Oral	AusgemLipigem
Glatiramer	GRP-25987	Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled pen	Injection	Copaxone
Glatiramer	GRP-25987	Injection containing glatiramer acetate 40 mg in 1 mL single dose pre-filled syringe	Injection	CopaxoneGlatira
Gliclazide	GRP-786	Tablet 30 mg (modified release)	Oral	APO-Gliclazide MRGliclazide MR ViatrisGliclazide Sandoz MRPharmacor Gliclazide MR
Gliclazide	GRP-787	Tablet 80 mg	Oral	APX-GliclazideNidem
Gliclazide	GRP-15200	Tablet 60 mg (modified release)	Oral	ARDIX GLICLAZIDE 60mg MRARX-Gliclazide MRDiamicron 60mg MRGliclazide Lupin MRGliclazide Sandoz MRPharmacor Gliclazide MR
Glimepiride	GRP-1265	Tablet 1 mg	Oral	ARX-GLIMEPIRIDEGlimepiride SandozGLIMEPIRIDE-WGR
Glimepiride	GRP-1266	Tablet 2 mg	Oral	ARX-GLIMEPIRIDEGlimepiride SandozGLIMEPIRIDE-WGR
Glimepiride	GRP-1267	Tablet 3 mg	Oral	ARX-GLIMEPIRIDEGlimepiride Sandoz
Glimepiride	GRP-1268	Tablet 4 mg	Oral	ARX-GLIMEPIRIDEGlimepiride SandozGLIMEPIRIDE-WGR
Glipizide	GRP-788	Tablet 5 mg	Oral	MelizideMinidiab
Guanfacine	GRP-31050	Tablet 1 mg (as hydrochloride)	Oral	Guanfacine MHCGuanfacine SandozGuanfacine ViatrisIntuniv
Guanfacine	GRP-31052	Tablet 2 mg (as hydrochloride)	Oral	Guanfacine MHCGuanfacine SandozGuanfacine ViatrisIntuniv
Guanfacine	GRP-31054	Tablet 3 mg (as hydrochloride)	Oral	Guanfacine MHCGuanfacine SandozGuanfacine ViatrisIntuniv
Guanfacine	GRP-31056	Tablet 4 mg (as hydrochloride)	Oral	Guanfacine MHCGuanfacine SandozGuanfacine ViatrisIntuniv
Haloperidol	GRP-30175	Injection 5 mg in 1 mL	Injection	HALOPERIDOL MEDSURGESerenace
Hydrocortisone	GRP-794	Cream containing hydrocortisone acetate 10 mg per g, 50 g	Application	Cortic-DS 1%Sigmacort
Hydrocortisone	GRP-796	Ointment containing hydrocortisone acetate 10 mg per g, 50 g	Application	Cortic-DS 1%Sigmacort
Hydrocortisone	GRP-22226	Tablet 20 mg	Oral	Hydrocortisone Viatris 20Hysone 20
Hydrocortisone	GRP-22228	Tablet 4 mg	Oral	Hydrocortisone Viatris 4Hysone 4
Hydromorphone	GRP-23122	Injection containing hydromorphone hydrochloride 2 mg in 1 mL	Injection	DilaudidHydromorphone-hamelnHYDROMORPHONE JUNOMEDSURGE HYDROMORPHONE 2 mg/1 mL
Hydromorphone	GRP-23124	Injection containing hydromorphone hydrochloride 10 mg in 1 mL	Injection	Dilaudid-HPHydromorphone-hameln-HPHYDROMORPHONE JUNO-HPMEDSURGE HYDROMORPHONE HP 10 mg/1 mL
Hydromorphone	GRP-25761	Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL	Oral	Hikma
Hydromorphone	GRP-25761	Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A)	Oral	Hydromorphone hydrochloride oral solution, USP (Medsurge)
Hydroxocobalamin	GRP-797	Injection 1 mg (as acetate) in 1 mL	Injection	Cobal-B12Vita-B12
Hydroxocobalamin	GRP-797	Injection 1 mg (as chloride) in 1 mL	Injection	Hydroxo-B12Neo-B12
Hydroxycarbamide	GRP-24230	Capsule 500 mg	Oral	HydreaHYDROXYCARBAMIDE MEDSURGE
Hydroxychloroquine	GRP-901	Tablet containing hydroxychloroquine sulfate 200 mg	Oral	APO- HydroxychloroquineHequinelHydroxychloroquine GHPlaquenil
Hyoscine	GRP-21804	Injection containing hyoscine butylbromide 20 mg in 1 mL	Injection	BuscopanHYOSCINE BUTYLBROMIDE-AFTHYOSCINE BUTYLBROMIDE MEDSURGEHYOSCINE BUTYLBROMIDE SXP
Hypromellose with dextran	GRP-801	Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL	Application to the eye	Poly-TearsTears Naturale
Ibuprofen	GRP-21698	Tablet 400 mg	Oral	APO-Ibuprofen 400BrufenWGR-IBUPROFEN 400
Icatibant	GRP-24088	Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe	Injection	Cipla IcatibantFyzantIcatibant Lupin
Imatinib	GRP-20972	Capsule 100 mg (as mesilate)	Oral	ARX-IMATINIBIMATINIB-DRLA
Imatinib	GRP-20972	Tablet 100 mg (as mesilate)	Oral	GilmatGlivecImanibIMATINIB RBXImatinib SandozImatinib-Teva
Imatinib	GRP-20974	Capsule 400 mg (as mesilate)	Oral	ARX-IMATINIBIMATINIB-DRLAImatinib GH
Imatinib	GRP-20974	Tablet 400 mg (as mesilate)	Oral	GilmatGlivecImanibIMATINIB RBXImatinib SandozImatinib-Teva
Imipramine	GRP-803	Tablet containing imipramine hydrochloride 25 mg	Oral	Tofranil 25
Imipramine	GRP-803	Tablet containing imipramine hydrochloride 25 mg (s19A)	Oral	Imipramine (Leading)
Imiquimod	GRP-6755	Cream 50 mg per g, 250 mg single use sachets, 12	Application	AldaraAPO-Imiquimod
Imiquimod	GRP-6755	Cream 50 mg per g, 2 g, 2	Application	Aldara Pump
Indapamide	GRP-804	Tablet containing indapamide hemihydrate 2.5 mg	Oral	Dapa-TabsInsig
Indapamide	GRP-15111	Tablet containing indapamide hemihydrate 1.5 mg (sustained release)	Oral	APO-Indapamide SRNatrilix SROdaplix SR
Indometacin	GRP-805	Capsule 25 mg	Oral	ArthrexinIndocid
Infliximab	GRP-17535	Powder for I.V. infusion 100 mg	Injection	InflectraIxifiRemicadeRemsimaRenflexis
Ipratropium	GRP-30103	Pressurised inhalation containing ipratropium bromide monohydrate 21 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	AtroventCipla Ipratropium
Irbesartan	GRP-1208	Tablet 150 mg	Oral	Abisart 150APO-IrbesartanAvaproAVSARTANBlooms IrbesartanIrbesartan SandozIRBESARTAN-WGRKarvea
Irbesartan	GRP-1209	Tablet 300 mg	Oral	Abisart 300APO-IrbesartanAvaproAVSARTANBlooms IrbesartanIrbesartan SandozIRBESARTAN-WGRKarvea
Irbesartan	GRP-1210	Tablet 75 mg	Oral	Abisart 75APO-IrbesartanAVSARTANBlooms IrbesartanIrbesartan SandozIRBESARTAN-WGR
Irbesartan with hydrochlorothiazide	GRP-1256	Tablet 150 mg-12.5 mg	Oral	Abisart HCTZ 150/12.5APO-Irbesartan HCTZAvapro HCT 150/12.5AVSARTAN HCT 150/12.5Irbesartan/HCT SandozIRBESARTAN HCTZ-WGR 150/12.5Karvezide 150/12.5
Irbesartan with hydrochlorothiazide	GRP-1257	Tablet 300 mg-12.5 mg	Oral	Abisart HCTZ 300/12.5APO-Irbesartan HCTZAvapro HCT 300/12.5AVSARTAN HCT 300/12.5Irbesartan/HCT SandozIRBESARTAN HCTZ-WGR 300/12.5Karvezide 300/12.5
Irbesartan with hydrochlorothiazide	GRP-1258	Tablet 300 mg-25 mg	Oral	Abisart HCTZ 300/25APO-Irbesartan HCTZAvapro HCT 300/25AVSARTAN HCT 300/25Irbesartan/HCT SandozIRBESARTAN HCTZ-WGR 300/25Karvezide 300/25
Isosorbide mononitrate	GRP-1003	Tablet 120 mg (sustained release)	Oral	Imdur 120 mgMonodur 120 mg
Isosorbide mononitrate	GRP-1004	Tablet 60 mg (sustained release)	Oral	APO-Isosorbide MononitrateDurideImdur DuruleISOBIDE MRISOSORBIDE MR-WGR
Isotretinoin	GRP-810	Capsule 10 mg	Oral	APO-IsotretinoinDermataneIsotretinoin GXIsotretinoin LupinISOTRETINOIN-WGROratane
Isotretinoin	GRP-811	Capsule 20 mg	Oral	APO-IsotretinoinDermataneIsotretinoin Dr.Reddy'sIsotretinoin GXIsotretinoin LupinISOTRETINOIN-WGROratanePharmacor IsotretinoinRoaccutane
Isotretinoin	GRP-14890	Capsule 40 mg	Oral	DermataneOratane
Itraconazole	GRP-21101	Capsule 100 mg	Oral	ItracapITRANOXItrazo
Ivabradine	GRP-22540	Tablet 5 mg (as hydrochloride)	Oral	APO-IvabradineCoralanIVABRADINE-WGR
Ivabradine	GRP-22542	Tablet 7.5 mg (as hydrochloride)	Oral	APO-IvabradineCoralan
Ivermectin	GRP-31060	Tablet 3 mg	Oral	GLENMECTStromectol
Lacosamide	GRP-26015	Tablet 100 mg	Oral	LACOMEDLacosamLacosamide ARXLacosamide LupinLacosamide SandozVimcosaVimpat
Lacosamide	GRP-26017	Tablet 150 mg	Oral	LACOMEDLacosamLacosamide ARXLacosamide LupinLacosamide SandozVimcosaVimpat
Lacosamide	GRP-26019	Tablet 200 mg	Oral	LACOMEDLacosamLacosamide ARXLacosamide LupinLacosamide SandozVimcosaVimpat
Lacosamide	GRP-26021	Tablet 50 mg	Oral	LACOMEDLacosamLacosamide ARXLacosamide LupinLacosamide SandozVimcosaVimpat
Lacosamide	GRP-26107	Tablet 100 mg	Oral	LACOMEDLacosamide SandozVimcosaVimpat
Lacosamide	GRP-26109	Tablet 150 mg	Oral	LACOMEDVimcosaVimpat
Lacosamide	GRP-30514	Oral solution 10 mg per mL, 200 mL	Oral	LACOMEDVimpat
Lamivudine	GRP-1137	Tablet 100 mg	Oral	ZeffixZetlam
Lamivudine	GRP-1138	Tablet 150 mg	Oral	3TCLamivudine Viatris
Lamivudine	GRP-1139	Tablet 300 mg	Oral	3TCLamivudine Viatris
Lamivudine with zidovudine	GRP-13695	Tablet 150 mg-300 mg	Oral	CombivirLamivudine/Zidovudine Viatris 150/300
Lamotrigine	GRP-1084	Tablet 100 mg	Oral	APX-LamotrigineLamictalLAMITANLamotrigine GHLAMOTRIGINE-WGRLogemReedos 100Sandoz Lamotrigine
Lamotrigine	GRP-1085	Tablet 200 mg	Oral	APX-LamotrigineLamictalLAMITANLamotrigine GHLAMOTRIGINE-WGRLogemReedos 200Sandoz Lamotrigine
Lamotrigine	GRP-1086	Tablet 25 mg	Oral	APX-LamotrigineLamictalLAMITANLamotrigine GHLAMOTRIGINE-WGRLogemReedos 25Sandoz Lamotrigine
Lamotrigine	GRP-1088	Tablet 50 mg	Oral	APX-LamotrigineLamictalLAMITANLamotrigine GHLAMOTRIGINE-WGRLogemReedos 50Sandoz Lamotrigine
Lanreotide	GRP-27167	Injection 120 mg (as acetate) in single dose pre-filled syringe	Injection	MytolacSomatuline Autogel
Lanreotide	GRP-27168	Injection 60 mg (as acetate) in single dose pre-filled syringe	Injection	MytolacSomatuline Autogel
Lanreotide	GRP-27169	Injection 90 mg (as acetate) in single dose pre-filled syringe	Injection	MytolacSomatuline Autogel
Lansoprazole	GRP-1068	Capsule 30 mg	Oral	APO-LansoprazoleLanzopranZopral
Lansoprazole	GRP-1068	Tablet 30 mg (orally disintegrating)	Oral	APO-Lansoprazole ODTLansoprazole ODT GHZopral ODTZoton FasTabs
Lansoprazole	GRP-12749	Tablet 15 mg (orally disintegrating)	Oral	APO-Lansoprazole ODTLansoprazole ODT GHZopral ODTZoton FasTabs
Latanoprost	GRP-1206	Eye drops 50 micrograms per mL, 2.5 mL	Application to the eye	APO-LatanoprostLatanoprost SandozXalaprostXalatan
Latanoprost with timolol	GRP-683	Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL	Application to the eye	APO-Latanoprost/Timolol 0.05/5XalacomXalamol 50/5
Leflunomide	GRP-1245	Tablet 10 mg	Oral	APO-LEFLUNOMIDEAravaAtaris 10Leflunomide generichealthLeflunomide SandozLEFLUNOMIDE-WGRLunava 10
Leflunomide	GRP-1246	Tablet 20 mg	Oral	APO-LEFLUNOMIDEAravaAtaris 20Leflunomide generichealthLeflunomide SandozLEFLUNOMIDE-WGRLunava 20
Lercanidipine	GRP-661	Tablet containing lercanidipine hydrochloride 10 mg	Oral	ARX-LERCANIDIPINELercanLERCANIDIPINE-WGRZanidipZircol 10
Lercanidipine	GRP-662	Tablet containing lercanidipine hydrochloride 20 mg	Oral	ARX-LERCANIDIPINELercanLERCANIDIPINE-WGRZanidipZircol 20
Letrozole	GRP-1207	Tablet 2.5 mg	Oral	ARX-LETROZOLEFemara 2.5 mgFemoletGynotrilLetrozole GHLetrozole SandozLETROZOLE-WGRPharmacor Letrozole 2.5
Levetiracetam	GRP-686	Tablet 1 g	Oral	APO-LevetiracetamKeppraLevactamLevetiracetam GHLevetiracetam SZLevetiracetam ViatrisLEVETIRACETAM-WGRLevi 1000
Levetiracetam	GRP-687	Tablet 250 mg	Oral	APO-LevetiracetamKeppraLevactamLevetiracetam GHLevetiracetam SZLevetiracetam ViatrisLEVETIRACETAM-WGRLevi 250
Levetiracetam	GRP-688	Tablet 500 mg	Oral	APO-LevetiracetamKeppraLevactamLevetiracetam GHLevetiracetam SZLevetiracetam ViatrisLEVETIRACETAM-WGRLevi 500
Levetiracetam	GRP-16384	Oral solution 100 mg per mL, 300 mL	Oral	APO-LevetiracetamKeppraKerronLevetiracetam-AFTLevetiracetam GH
Levodopa with carbidopa	GRP-821	Tablet 100 mg-25 mg (as monohydrate)	Oral	APO-Levodopa/CarbidopaKinsonORIDOPA 100/25SINADOPA 100/25Sinemet 100/25
Levodopa with carbidopa	GRP-822	Tablet 250 mg-25 mg (as monohydrate)	Oral	APO-Levodopa/CarbidopaSINADOPA 250/25Sinemet
Levodopa with carbidopa and entacapone	GRP-24074	Tablet 100 mg-25 mg (as monohydrate)-200 mg	Oral	CarleventL.C.E. SandozLectevaStalevo 100/25/200mg
Levodopa with carbidopa and entacapone	GRP-24076	Tablet 125 mg-31.25 mg (as monohydrate)-200 mg	Oral	CarleventL.C.E. SandozLectevaStalevo 125/31.25/200mg
Levodopa with carbidopa and entacapone	GRP-24078	Tablet 150 mg-37.5 mg (as monohydrate)-200 mg	Oral	CarleventL.C.E. SandozLectevaStalevo 150/37.5/200mg
Levodopa with carbidopa and entacapone	GRP-24080	Tablet 200 mg-50 mg (as monohydrate)-200 mg	Oral	CarleventL.C.E. SandozLectevaStalevo 200/50/200mg
Levodopa with carbidopa and entacapone	GRP-24082	Tablet 50 mg-12.5 mg (as monohydrate)-200 mg	Oral	CarleventL.C.E. SandozLectevaStalevo 50/12.5/200mg
Levodopa with carbidopa and entacapone	GRP-24084	Tablet 75 mg-18.75 mg (as monohydrate)-200 mg	Oral	CarleventL.C.E. SandozLectevaStalevo 75/18.75/200mg
Levonorgestrel	GRP-31048	Tablets 30 micrograms, 28	Oral	Microlut 28Mirolesa
Levonorgestrel with ethinylestradiol	GRP-824	Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets	Oral	Eleanor 150/30 EDEvelyn 150/30 EDFemme-Tab ED 30/150Lenest 30 EDLEVETH 150/30 EDLevlen EDMicronelle 30 ED
Levonorgestrel with ethinylestradiol	GRP-826	Pack containing 6 tablets 50 micrograms-30 micrograms, 5 tablets 75 micrograms-40 micrograms, 10 tablets 125 micrograms-30 micrograms and 7 inert tablets	Oral	Logynon EDTriquilar ED
Levothyroxine	GRP-945	Tablet containing 100 micrograms anhydrous levothyroxine sodium	Oral	APO-LevothyroxineEutroxsigLevothyroxine LupLevothyroxine SandozLEVOXINEOroxineThyrox
Levothyroxine	GRP-946	Tablet containing 200 micrograms anhydrous levothyroxine sodium	Oral	APO-LevothyroxineEutroxsigLevothyroxine LupLevothyroxine SandozLEVOXINEOroxineThyrox
Levothyroxine	GRP-947	Tablet containing 50 micrograms anhydrous levothyroxine sodium	Oral	APO-LevothyroxineEutroxsigLevothyroxine LupLevothyroxine SandozLEVOXINEOroxineThyrox
Levothyroxine	GRP-948	Tablet containing 75 micrograms anhydrous levothyroxine sodium	Oral	APO-LevothyroxineEutroxsigLevothyroxine LupLevothyroxine SandozLEVOXINEOroxineThyrox
Levothyroxine	GRP-27296	Tablet containing 100 micrograms anhydrous levothyroxine sodium	Oral	EltroxinLevothox
Levothyroxine	GRP-27300	Tablet containing 200 micrograms anhydrous levothyroxine sodium	Oral	EltroxinLevothox
Levothyroxine	GRP-27302	Tablet containing 50 micrograms anhydrous levothyroxine sodium	Oral	EltroxinLevothox
Levothyroxine	GRP-27304	Tablet containing 75 micrograms anhydrous levothyroxine sodium	Oral	EltroxinLevothox
Lisinopril	GRP-1005	Tablet 10 mg	Oral	APO-LisinoprilFibsol 10Lisinopril SandozLISINOPRIL-WGRZestrilZinopril 10
Lisinopril	GRP-1006	Tablet 20 mg	Oral	APO-LisinoprilFibsol 20Lisinopril SandozLISINOPRIL-WGRZestrilZinopril 20
Lisinopril	GRP-1007	Tablet 5 mg	Oral	APO-LisinoprilFibsol 5Lisinopril SandozLISINOPRIL-WGRZestrilZinopril 5
Loperamide	GRP-831	Capsule containing loperamide hydrochloride 2 mg	Oral	GastrexGastro-Stop
Lurasidone	GRP-24090	Tablet containing lurasidone hydrochloride 40 mg	Oral	APO-LurasidoneLavioneLurasidone LupinLurasidone SandozLURASIDONE SUNLURASIDONE-WGRPharmacor Lurasidone
Lurasidone	GRP-24092	Tablet containing lurasidone hydrochloride 80 mg	Oral	APO-LurasidoneLavioneLurasidone LupinLurasidone SandozLURASIDONE SUNLURASIDONE-WGRPharmacor Lurasidone
Macrogol 3350	GRP-13754	Sachets containing powder for oral solution 13.125 g with electrolytes, 30	Oral	APOHEALTH Macrogol with ElectrolytesAPO-MACROGOL plus ELECTROLYTESChemists' Own Constipation Relief with electrolytesMacrovic
Maraviroc	GRP-29333	Tablet 150 mg	Oral	CelsentriMaraviroc Waymade
Maraviroc	GRP-29335	Tablet 300 mg	Oral	CelsentriMaraviroc Waymade
Medroxyprogesterone	GRP-833	Tablet containing medroxyprogesterone acetate 10 mg	Oral	ProveraRalovera
Medroxyprogesterone	GRP-834	Tablet containing medroxyprogesterone acetate 10 mg	Oral	ProveraRalovera
Medroxyprogesterone	GRP-835	Tablet containing medroxyprogesterone acetate 5 mg	Oral	ProveraRalovera
Mefenamic acid	GRP-25929	Capsule 250 mg	Oral	FEMINPonstan
Meloxicam	GRP-674	Capsule 15 mg	Oral	APO-MeloxicamMELOBICMELOXICAM-WGRMobicMovalis 15Moxicam
Meloxicam	GRP-674	Tablet 15 mg	Oral	APX-MeloxicamCIPLA MELOXICAM 15MELOBICMeloxibellMeloxicam SandozMeloxicam ViatrisMELOXICAM-WGRMobicMovalis 15Moxicam 15
Meloxicam	GRP-675	Capsule 7.5 mg	Oral	APO-MeloxicamMELOBICMELOXICAM-WGRMobicMovalis 7.5Moxicam
Meloxicam	GRP-675	Tablet 7.5 mg	Oral	APX-MeloxicamCIPLA MELOXICAM 7.5MELOBICMeloxibellMeloxicam SandozMeloxicam ViatrisMELOXICAM-WGRMobicMovalis 7.5Moxicam 7.5
Memantine	GRP-718	Tablet containing memantine hydrochloride 10 mg	Oral	APO-MemantineEbixaMemantine generichealthMemanxa
Memantine	GRP-14693	Tablet containing memantine hydrochloride 20 mg	Oral	APO-MemantineEbixaMemantine generichealth
Mercaptopurine	GRP-23806	Tablet containing mercaptopurine monohydrate 50 mg	Oral	ARX-MercaptopurineMERCAPTOPURINE-LINKPurinethol
Mesalazine	GRP-25946	Tablet 1.2 g (prolonged release)	Oral	Mesalazine 1.2 TAKEDAMESALZMezavantMEZTAS
Metformin	GRP-836	Tablet containing metformin hydrochloride 1 g	Oral	APX-METFORMINBlooms The Chemist Metformin 1000 mgDiabex 1000Diaformin 1000Diaformin ViatrisFormet 1000Glucobete 1000Metformin GHMetformin SandozMETFORMIN-WGR
Metformin	GRP-837	Tablet containing metformin hydrochloride 500 mg	Oral	APX-METFORMINBlooms The Chemist Metformin 500 mgDiabexDiaforminDiaformin ViatrisFORMET 500Glucobete 500Metformin GHMetformin SandozMETFORMIN-WGR
Metformin	GRP-838	Tablet (extended release) containing metformin hydrochloride 500 mg	Oral	APO-Metformin XR 500Blooms Metformin XRDiabex XR 500Diaformin Alphapharm XRMetex XRMetformin Lupin XRMetformin Sandoz XRMETFORMIN-WGR XRPharmacor Metformin XR
Metformin	GRP-839	Tablet containing metformin hydrochloride 850 mg	Oral	APX-METFORMINBlooms The Chemist Metformin 850 mgDiabex 850Diaformin 850Diaformin ViatrisFORMET 850Glucobete 850Metformin SandozMETFORMIN-WGR
Metformin	GRP-15054	Tablet (extended release) containing metformin hydrochloride 1 g	Oral	APO-Metformin XR 1000Blooms Metformin XRDiabex XR 1000Diaformin Alphapharm XRDiaformin XR 1000METEX XRMetformin Lupin XRMetformin Sandoz XRMETFORMIN-WGR XRPharmacor Metformin XR
Methadone	GRP-840	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL	Oral	Aspen Methadone SyrupBiodone Forte
Methadone	GRP-841	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL	Oral	Aspen Methadone SyrupBiodone Forte
Methadone	GRP-29248	Tablet containing methadone hydrochloride 10 mg	Oral	METHADONE-AFTPhyseptone
Methenamine	GRP-24491	Tablet containing methenamine hippurate 1 g	Oral	APOHEALTH Urinary Tract AntibacterialChemists' Own Urinary Tract AntibacterialHiprexUraleevUramet
Methotrexate	GRP-844	Tablet 2.5 mg	Oral	ARX-MethotrexateChexateMethoblastin
Methotrexate	GRP-27787	Tablet 10 mg	Oral	ARX-MethotrexateChexateMethoblastin
Methotrexate	GRP-28540	Tablet 10 mg	Oral	ARX-MethotrexateChexateMethoblastin
Methotrexate	GRP-29341	Tablet 10 mg	Oral	ChexateMethoblastin
Methyldopa	GRP-845	Tablet 250 mg (as sesquihydrate)	Oral	AldometHydopa
Methylphenidate	GRP-21704	Tablet containing methylphenidate hydrochloride 10 mg	Oral	ArtigeRinidateRitalin 10
Methylphenidate	GRP-25713	Tablet containing methylphenidate hydrochloride 18 mg (extended release) Concerta (Switzerland) (S19A)	Oral	Concerta (Switzerland)
Methylphenidate	GRP-25713	Tablet containing methylphenidate hydrochloride 18 mg (extended release)	Oral	ConcertaMethylphenidate Sandoz XRMETHYLPHENIDATE-TEVA XRMethylphenidate XR ARX
Methylphenidate	GRP-25715	Tablet containing methylphenidate hydrochloride 27 mg (extended release)	Oral	ConcertaMethylphenidate Sandoz XRMETHYLPHENIDATE-TEVA XRMethylphenidate XR ARX
Methylphenidate	GRP-25715	Tablet containing methylphenidate hydrochloride 27 mg (modified release) (Spain) (S19A)	Oral	Atenza (Spain)
Methylphenidate	GRP-25717	Tablet containing methylphenidate hydrochloride 36 mg (extended release) Concerta (Switzerland) (S19A)	Oral	Concerta (Switzerland)
Methylphenidate	GRP-25717	Tablet containing methylphenidate hydrochloride 36 mg (extended release)	Oral	ConcertaMethylphenidate Sandoz XRMETHYLPHENIDATE-TEVA XRMethylphenidate XR ARX
Methylphenidate	GRP-25719	Tablet containing methylphenidate hydrochloride 54 mg (extended release) Concerta (Switzerland) (S19A)	Oral	Concerta (Switzerland)
Methylphenidate	GRP-25719	Tablet containing methylphenidate hydrochloride 54 mg (extended release)	Oral	ConcertaMethylphenidate Sandoz XRMETHYLPHENIDATE-TEVA XRMethylphenidate XR ARX
Methylphenidate	GRP-25719	Tablet containing methylphenidate hydrochloride 54 mg (modified release) (Spain) (S19A)	Oral	Atenza (Spain)
Methylphenidate	GRP-27026	Capsule containing methylphenidate hydrochloride 10 mg (modified release)	Oral	ATTORA LARitalin LARubifen LA
Methylphenidate	GRP-27028	Capsule containing methylphenidate hydrochloride 20 mg (modified release)	Oral	ATTORA LARitalin LARubifen LA
Methylphenidate	GRP-27030	Capsule containing methylphenidate hydrochloride 30 mg (modified release)	Oral	ATTORA LARitalin LARubifen LA
Methylphenidate	GRP-27032	Capsule containing methylphenidate hydrochloride 40 mg (modified release)	Oral	ATTORA LARitalin LARubifen LA
Methylphenidate	GRP-27034	Capsule containing methylphenidate hydrochloride 60 mg (modified release)	Oral	ATTORA LARitalin LARubifen LA
Methylprednisolone	GRP-27876	Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g	Application	Advantan (Fatty)Metvant (Fatty)Supriad Fatty OintmentTanilone (Fatty)
Methylprednisolone	GRP-27921	Cream containing methylprednisolone aceponate 1 mg per g, 15 g	Application	AdvantanSupriad Cream
Methylprednisolone	GRP-27923	Ointment containing methylprednisolone aceponate 1 mg per g, 15 g	Application	AdvantanMetvantSupriad Ointment
Metoclopramide	GRP-14331	Tablet containing 10 mg metoclopramide hydrochloride (as monohydrate)	Oral	APO-MetoclopramideEMEXLONMaxolonMETOCLOPRAMIDE-WGRPramin
Metoclopramide	GRP-28147	Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL	Injection	Metoclopramide HCl MedsurgeMETOCLOPRAMIDE INJECTION BP
Metoprolol	GRP-853	Tablet containing metoprolol tartrate 100 mg	Oral	APO-MetoprololBetalocMetoprolol SandozMETOPROLOL-WGRMetrol 100Minax 100
Metoprolol	GRP-854	Tablet containing metoprolol tartrate 50 mg	Oral	APO-MetoprololBetalocMetoprolol SandozMETOPROLOL-WGRMetrol 50Minax 50
Metoprolol succinate	GRP-14759	Tablet 23.75 mg (controlled release)	Oral	Metrol-XL 23.75Minax XLTopreloc-XL
Metoprolol succinate	GRP-14761	Tablet 47.5 mg (controlled release)	Oral	Metrol-XL 47.5Minax XLTopreloc-XLToprol-XL 47.5
Metoprolol succinate	GRP-14763	Tablet 95 mg (controlled release)	Oral	Metrol-XL 95Minax XLTopreloc-XLToprol-XL 95
Metoprolol succinate	GRP-14765	Tablet 190 mg (controlled release)	Oral	Metrol-XL 190Minax XLTopreloc-XLToprol-XL 190
Metronidazole	GRP-856	Tablet 200 mg	Oral	Metrogyl 200METRONIDAMED
Metronidazole	GRP-857	Tablet 400 mg	Oral	FlagylMetrogyl 400METRONIDAMED
Mifepristone and misoprostol	GRP-30787	Pack containing 1 tablet mifepristone 200 mg and 4 tablets misoprostol 200 micrograms	Oral	ARZESTRAMS-2 Step
Minocycline	GRP-860	Tablet 50 mg (as hydrochloride)	Oral	Akamin 50Minomycin-50
Mirtazapine	GRP-1294	Tablet 30 mg	Oral	APX-MirtazapineAvanzaAxit 30Blooms The Chemist MirtazapineMIRTANZAMirtazapine SandozMIRTAZAPINE-WGR
Mirtazapine	GRP-1296	Tablet 45 mg	Oral	APX-MirtazapineAxit 45Blooms The Chemist MirtazapineMIRTANZAMirtazapine SandozMIRTAZAPINE-WGR
Mirtazapine	GRP-6675	Tablet 15 mg	Oral	APX-MirtazapineAxit 15Blooms The Chemist MirtazapineMIRTANZAMirtazapine SandozMIRTAZAPINE-WGR
Moclobemide	GRP-998	Tablet 150 mg	Oral	Amira 150AurorixClobemixMoclobemide SandozMOCLOBEMIDE-WGR
Moclobemide	GRP-999	Tablet 300 mg	Oral	Amira 300Aurorix 300 mgClobemixMoclobemide SandozMOCLOBEMIDE-WGR
Modafinil	GRP-20563	Tablet 100 mg	Oral	APO-ModafinilModafinModafinil GHModafinil SandozModafinil ViatrisMODAFINIL-WGRModavigil
Mometasone	GRP-1102	Cream containing mometasone furoate 1 mg per g, 15 g	Application	Elocon Alcohol FreeGLENMARK MOMETASONE Alcohol FreeNovasone
Mometasone	GRP-1103	Lotion containing mometasone furoate 1 mg per g, 30 mL	Application	EloconNovasoneZatamil
Mometasone	GRP-1104	Ointment containing mometasone furoate 1 mg per g, 15 g	Application	EloconGLENMARK MOMETASONENovasoneZatamil
Montelukast	GRP-13527	Tablet, chewable, 4 mg (as sodium)	Oral	APX-MONTELUKASTMONTELAIR 4Montelukast LupinMontelukast Sandoz 4Montelukast ViatrisMONTELUKAST-WGR
Montelukast	GRP-13529	Tablet, chewable, 5 mg (as sodium)	Oral	APX-MONTELUKASTMONTELAIR 5Montelukast LupinMontelukast Sandoz 5Montelukast ViatrisMONTELUKAST-WGR
Morphine	GRP-20751	Injection containing morphine hydrochloride trihydrate 10 mg in 1 mL	Injection	Morphine Juno
Morphine	GRP-20751	Injection containing morphine sulfate pentahydrate 10 mg in 1 mL	Injection	MORPHINE SULFATE 10 mg/1 mL MEDSURGE
Morphine	GRP-28064	Oral solution containing morphine hydrochloride trihydrate 2 mg per mL, 1 mL	Oral	Morphine PhebraOrdine 2
Morphine	GRP-28726	Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL	Oral	Morphine PhebraOrdine 5
Moxonidine	GRP-22253	Tablet 200 micrograms	Oral	APO-MoxonidineARX-MOXONIDINEMoxonidine GHMoxonidine GXMoxonidine ViatrisMOXONIDINE-WGRMoxotensPhysiotens
Moxonidine	GRP-22255	Tablet 400 micrograms	Oral	APO-MoxonidineARX-MOXONIDINEMoxonidine GHMoxonidine GXMoxonidine ViatrisMOXONIDINE-WGRMoxotensPhysiotens
Mycophenolic acid	GRP-1163	Capsule containing mycophenolate mofetil 250 mg	Oral	APO-MycophenolateMycophenolate SandozPharmacor Mycophenolate 250
Mycophenolic acid	GRP-1164	Tablet containing mycophenolate mofetil 500 mg	Oral	ARX-MYCOPHENOLATECeptolateMycophenolate GHMycophenolate SandozPharmacor Mycophenolate 500
Mycophenolic acid	GRP-26826	Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL	Oral	CellCeptPharmacor Mycophenolate
Mycophenolic acid	GRP-27955	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Mycophenolic Acid ARXMYCOTEXMyfortic
Mycophenolic acid	GRP-28189	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Mycophenolic Acid ARXMyfortic
Naloxone	GRP-21274	Injection containing naloxone hydrochloride 400 micrograms in 1 mL ampoule	Injection	Naloxone Hydrochloride (DBL)Naloxone JunoNALOXONE SXP
Naltrexone	GRP-1252	Tablet containing naltrexone hydrochloride 50 mg	Oral	ARX-NALTREXONENaltrexone GH
Naproxen	GRP-867	Tablet 1 g (sustained release)	Oral	Naprosyn SR1000Proxen SR 1000
Naproxen	GRP-870	Tablet 750 mg (sustained release)	Oral	Naprosyn SR750Proxen SR 750
Naproxen	GRP-1063	Tablet containing naproxen sodium 550 mg	Oral	Anaprox 550Crysanal
Nebivolol	GRP-22480	Tablet 1.25 mg (as hydrochloride)	Oral	APO-NebivololNebiletNebivolol LupinNebivolol SandozNebivolol ViatrisNEBIVOLOL-WGRNepiten
Nebivolol	GRP-22482	Tablet 10 mg (as hydrochloride)	Oral	APO-NebivololNebalocNebiletNebivolol LupinNebivolol SandozNEBIVOLOL-WGRNepiten
Nebivolol	GRP-22484	Tablet 5 mg (as hydrochloride)	Oral	APO-NebivololNebalocNebiletNebivolol LupinNebivolol SandozNebivolol ViatrisNEBIVOLOL-WGRNepiten
Nicorandil	GRP-16055	Tablets 20 mg, 60	Oral	APO-NicorandilIkotab
Nicorandil	GRP-16153	Tablets 10 mg, 60	Oral	APO-NicorandilIkotab
Nilotinib	GRP-30979	Capsule 150 mg (as hydrochloride)	Oral	CeahaniMSN-NILOTINIBNILOTASTasigna
Nilotinib	GRP-30981	Capsule 200 mg (as hydrochloride)	Oral	CeahaniMSN-NILOTINIBNILOTASTasigna
Nitrazepam	GRP-876	Tablet 5 mg	Oral	AlodormMogadon
Nitrofurantoin	GRP-23944	Capsule 100 mg	Oral	ARX-NitrofurantoinNitrofurantoin BNM
Nitrofurantoin	GRP-23946	Capsule 50 mg	Oral	ARX-NitrofurantoinNitrofurantoin BNM
Nizatidine	GRP-1032	Capsule 150 mg	Oral	NizacTacidineTazac
Nizatidine	GRP-1033	Capsule 300 mg	Oral	NizacTacidineTazac
Norfloxacin	GRP-882	Tablet 400 mg	Oral	APO-NorfloxacinRoxin
Octreotide	GRP-1203	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide GHOctreotide (SUN)Sandostatin 0.1
Octreotide	GRP-1204	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide GHOctreotide (SUN)Sandostatin 0.05
Octreotide	GRP-1205	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide GHOctreotide (SUN)Sandostatin 0.5
Olanzapine	GRP-1171	Tablet 10 mg	Oral	APO-OLANZAPINEOlanzapine RBXOlanzapine SandozOzin 10PRYZEXZypineZyprexa
Olanzapine	GRP-1173	Tablet 10 mg (orally disintegrating)	Oral	APO-Olanzapine ODTOlanzapine Sandoz ODT 10PRYZEX ODTZypine ODT
Olanzapine	GRP-1173	Wafer 10 mg	Oral	Zyprexa Zydis
Olanzapine	GRP-1174	Tablet 15 mg (orally disintegrating)	Oral	APO-Olanzapine ODTOLANZAPINE ODT-WGROlanzapine Sandoz ODT 15PRYZEX ODTZypine ODT
Olanzapine	GRP-1174	Wafer 15 mg	Oral	Zyprexa Zydis
Olanzapine	GRP-1175	Tablet 2.5 mg	Oral	APO-OLANZAPINEOlanzapine RBXOlanzapine SandozOzin 2.5PRYZEXZypineZyprexa
Olanzapine	GRP-1177	Tablet 20 mg (orally disintegrating)	Oral	APO-Olanzapine ODTOlanzapine Sandoz ODT 20PRYZEX ODTZypine ODT
Olanzapine	GRP-1177	Wafer 20 mg	Oral	Zyprexa Zydis
Olanzapine	GRP-1178	Tablet 5 mg	Oral	APO-OLANZAPINEOlanzapine RBXOlanzapine SandozOzin 5PRYZEXZypineZyprexa
Olanzapine	GRP-1180	Tablet 5 mg (orally disintegrating)	Oral	APO-Olanzapine ODTOLANZAPINE ODT-WGROlanzapine Sandoz ODT 5PRYZEX ODTZypine ODT
Olanzapine	GRP-1180	Wafer 5 mg	Oral	Zyprexa Zydis
Olanzapine	GRP-1181	Tablet 7.5 mg	Oral	APO-OLANZAPINEOlanzapine RBXOlanzapine SandozOzin 7.5PRYZEXZypineZyprexa
Olmesartan	GRP-21125	Tablet containing olmesartan medoxomil 20 mg	Oral	APO-OlmesartanBlooms The Chemist OlmesartanOLMERTANOlmesartan - MYLOlmesartan SandozOLMESARTAN-WGROlmetecOlsetanPharmacor Olmesartan 20
Olmesartan	GRP-21127	Tablet containing olmesartan medoxomil 40 mg	Oral	APO-OlmesartanBlooms The Chemist OlmesartanOLMERTANOlmesartan - MYLOlmesartan SandozOLMESARTAN-WGROlmetecOlsetanPharmacor Olmesartan 40
Olmesartan with amlodipine	GRP-21135	Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)	Oral	APO-OLMESARTAN/AMLODIPINE 20/5OLMEKAROlmesartan/Amlodipine - MYL 20/5Olmesartan/Amlodipine SandozOLMESARTAN AMLODIPINE-WGR 20/5Pharmacor Olmesartan Amlodipine 20/5Sevikar 20/5
Olmesartan with amlodipine	GRP-21137	Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)	Oral	APO-OLMESARTAN/AMLODIPINE 40/5OLMEKAROlmesartan/Amlodipine - MYL 40/5Olmesartan/Amlodipine SandozOLMESARTAN AMLODIPINE-WGR 40/5Pharmacor Olmesartan Amlodipine 40/5Sevikar 40/5
Olmesartan with amlodipine	GRP-21139	Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)	Oral	APO-OLMESARTAN/AMLODIPINE 40/10OLMEKAROlmesartan/Amlodipine - MYL 40/10Olmesartan/Amlodipine SandozOLMESARTAN AMLODIPINE-WGR 40/10Pharmacor Olmesartan Amlodipine 40/10Sevikar 40/10
Olmesartan with amlodipine and hydrochlorothiazide	GRP-23646	Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg	Oral	APO-Olmesartan/Amlodipine/HCTZ 20/5/12.5Olamlo HCT 20/5/12.5Sevikar HCT 20/5/12.5
Olmesartan with amlodipine and hydrochlorothiazide	GRP-23648	Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 12.5 mg	Oral	APO-Olmesartan/Amlodipine/HCTZ 40/10/12.5Olamlo HCT 40/10/12.5Sevikar HCT 40/10/12.5
Olmesartan with amlodipine and hydrochlorothiazide	GRP-23650	Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate) and hydrochlorothiazide 25 mg	Oral	APO-Olmesartan/Amlodipine/HCTZ 40/10/25Olamlo HCT 40/10/25Sevikar HCT 40/10/25
Olmesartan with amlodipine and hydrochlorothiazide	GRP-23652	Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 12.5 mg	Oral	APO-Olmesartan/Amlodipine/HCTZ 40/5/12.5 tabletOlamlo HCT 40/5/12.5Sevikar HCT 40/5/12.5
Olmesartan with amlodipine and hydrochlorothiazide	GRP-23654	Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate) and hydrochlorothiazide 25 mg	Oral	APO-Olmesartan/Amlodipine/HCTZ 40/5/25 tabletOlamlo HCT 40/5/25Sevikar HCT 40/5/25
Olmesartan with hydrochlorothiazide	GRP-21129	Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg	Oral	APO-Olmesartan/HCTZ 20/12.5OLMERTAN COMBI 20/12.5Olmesartan HCT - MYL 20/12.5Olmesartan/HCT SandozOlmesartan HCT ViatrisOLMESARTAN HCTZ-WGR 20/12.5Olmetec PlusPharmacor Olmesartan HCTZ 20/12.5
Olmesartan with hydrochlorothiazide	GRP-21131	Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg	Oral	APO-Olmesartan/HCTZ 40/12.5OLMERTAN COMBI 40/12.5Olmesartan HCT - MYL 40/12.5Olmesartan/HCT SandozOlmesartan HCT ViatrisOLMESARTAN HCTZ-WGR 40/12.5Olmetec PlusPharmacor Olmesartan HCTZ 40/12.5
Olmesartan with hydrochlorothiazide	GRP-21133	Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg	Oral	APO-Olmesartan/HCTZ 40/25OLMERTAN COMBI 40/25Olmesartan HCT - MYL 40/25Olmesartan/HCT SandozOlmesartan HCT ViatrisOLMESARTAN HCTZ-WGR 40/25Olmetec PlusPharmacor Olmesartan HCTZ 40/25
Omalizumab	GRP-29828	Injection 75 mg in 0.5 mL single dose pre-filled pen	Injection	OmlycloXolair
Omalizumab	GRP-29828	Injection 75 mg in 0.5 mL single dose pre-filled syringe	Injection	OmlycloXolair
Omalizumab	GRP-29829	Injection 150 mg in 1 mL single dose pre-filled pen	Injection	OmlycloXolair
Omalizumab	GRP-29829	Injection 150 mg in 1 mL single dose pre-filled syringe	Injection	Omlyclo
Omeprazole	GRP-884	Capsule 20 mg	Oral	APO-OmeprazoleMaxorOMEPRAZOLE CAPS WGROmeprazole SandozPharmacor Omeprazole 20Probitor
Omeprazole	GRP-884	Tablet 20 mg	Oral	APO-OmeprazoleMaxor EC TabsOMEPRAZOLE-WGROzmep
Omeprazole	GRP-884	Tablet 20 mg (as magnesium)	Oral	Acimax TabletsLosec TabletsOmepralOmeprazole Sandoz
Ondansetron	GRP-984	Tablet (orally disintegrating) 4 mg	Oral	APX-Ondansetron ODTOndansetron ODT-DRLAOndansetron ODT LupinOndansetron ODT ViatrisOndansetron ODT VTRSONDANSETRON ODT-WGROndansetron SZ ODTZotren ODT
Ondansetron	GRP-984	Wafer 4 mg	Oral	Zofran Zydis
Ondansetron	GRP-986	Tablet (orally disintegrating) 8 mg	Oral	APX-Ondansetron ODTOndansetron ODT-DRLAOndansetron ODT LupinOndansetron ODT ViatrisOndansetron ODT VTRSONDANSETRON ODT-WGROndansetron SZ ODTZotren ODT
Ondansetron	GRP-986	Wafer 8 mg	Oral	Zofran Zydis
Ondansetron	GRP-988	Tablet 4 mg (as hydrochloride dihydrate)	Oral	APX-OndansetronOndansetron-DRLAOndansetron SZOndansetron Tablets ViatrisOndansetron VTRSONDANSETRON-WGRZofranZotren 4
Ondansetron	GRP-989	Tablet 4 mg (as hydrochloride dihydrate)	Oral	APX-OndansetronOndansetron-DRLAOndansetron SZOndansetron Tablets ViatrisONDANSETRON-WGRZofranZotren 4
Ondansetron	GRP-990	Tablet 8 mg (as hydrochloride dihydrate)	Oral	APX-OndansetronOndansetron-DRLAOndansetron SZOndansetron Tablets ViatrisOndansetron VTRSONDANSETRON-WGRZofranZotren 8
Ondansetron	GRP-991	Tablet 8 mg (as hydrochloride dihydrate)	Oral	APX-OndansetronOndansetron-DRLAOndansetron SZOndansetron Tablets ViatrisOndansetron VTRSONDANSETRON-WGRZofranZotren 8
Ondansetron	GRP-993	Tablet (orally disintegrating) 4 mg	Oral	APX-Ondansetron ODTOndansetron ODT-DRLAOndansetron ODT ViatrisONDANSETRON ODT-WGROndansetron SZ ODTZotren ODT
Ondansetron	GRP-995	Tablet (orally disintegrating) 8 mg	Oral	APX-Ondansetron ODTOndansetron ODT-DRLAOndansetron ODT ViatrisOndansetron ODT VTRSONDANSETRON ODT-WGROndansetron SZ ODTZotren ODT
Ondansetron	GRP-30197	Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL	Oral	ONDANSETRON-AFTZofran syrup 50 mL
Oxazepam	GRP-886	Tablet 15 mg	Oral	Alepam 15Serepax
Oxazepam	GRP-887	Tablet 30 mg	Oral	Alepam 30APO-OxazepamMurelaxOXAZEPAM-WGRSerepax
Oxycodone	GRP-15202	Tablet containing oxycodone hydrochloride 10 mg (controlled release)	Oral	Oxycodone SandozOxyContin
Oxycodone	GRP-15204	Tablet containing oxycodone hydrochloride 20 mg (controlled release)	Oral	Oxycodone SandozOxyContin
Oxycodone	GRP-15206	Tablet containing oxycodone hydrochloride 40 mg (controlled release)	Oral	Oxycodone SandozOxyContin
Oxycodone	GRP-15208	Tablet containing oxycodone hydrochloride 80 mg (controlled release)	Oral	Oxycodone SandozOxyContin
Oxycodone	GRP-16386	Tablet containing oxycodone hydrochloride 5 mg	Oral	ENDONEMayne Pharma Oxycodone IROxycodone ViatrisOxyndone
Oxycodone	GRP-23038	Capsule containing oxycodone hydrochloride 10 mg	Oral	Oxycodone BNMOxyNorm
Oxycodone	GRP-23041	Capsule containing oxycodone hydrochloride 20 mg	Oral	Oxycodone BNMOxyNorm
Oxycodone	GRP-23042	Capsule containing oxycodone hydrochloride 5 mg	Oral	Oxycodone BNMOxyNorm
Oxycodone with naloxone	GRP-29601	Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg	Oral	ARX-Oxycodone/Naloxone 10/5OXYCODONE NALOXONE ADVZ XR 10/5Targin 10/5mg
Oxycodone with naloxone	GRP-29603	Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg	Oral	ARX-Oxycodone/Naloxone 15/7.5Targin 15/7.5mg
Oxycodone with naloxone	GRP-29604	Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg	Oral	ARX-Oxycodone/Naloxone 2.5/1.25Targin 2.5/1.25 mg
Oxycodone with naloxone	GRP-29607	Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg	Oral	ARX-Oxycodone/Naloxone 20/10OXYCODONE NALOXONE ADVZ XR 20/10Targin 20/10mg
Oxycodone with naloxone	GRP-29609	Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg	Oral	ARX-Oxycodone/Naloxone 30/15OXYCODONE NALOXONE ADVZ XR 30/15Targin 30/15 mg
Oxycodone with naloxone	GRP-29611	Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg	Oral	ARX-Oxycodone/Naloxone 40/20OXYCODONE NALOXONE ADVZ XR 40/20Targin 40/20mg
Oxycodone with naloxone	GRP-29613	Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg	Oral	ARX-Oxycodone/Naloxone 5/2.5OXYCODONE NALOXONE ADVZ XR 5/2.5Targin 5/2.5mg
Oxycodone with naloxone	GRP-29615	Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg	Oral	ARX-Oxycodone/Naloxone 60/30Targin 60/30
Oxycodone with naloxone	GRP-29617	Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg	Oral	ARX-Oxycodone/Naloxone 80/40Targin 80/40
Palonosetron	GRP-26114	Injection 250 micrograms (as hydrochloride) in 5 mL	Injection	Palonosetron Dr.Reddy'sPalonosetron JNPALONOSETRON Medsurge
Pantoprazole	GRP-1115	Tablet (enteric coated) 20 mg (as sodium sesquihydrate)	Oral	APO-PantoprazoleAPX-PANTOPRAZOLEBTC PantoprazoleOzpanPanthronPantoprazole generichealthPantoprazole SandozPANTOPRAZOLE-WGRSalprazSomacSozol
Pantoprazole	GRP-1116	Tablet (enteric coated) 40 mg (as sodium sesquihydrate)	Oral	APO-PantoprazoleAPX-PANTOPRAZOLEBTC PantoprazoleI-PantoprazoleOzpanPanthronPantoprazole generichealthPantoprazole SandozPANTOPRAZOLE-WGRSalprazSomacSozol
Paracetamol	GRP-888	Tablet 500 mg	Oral	APO-ParacetamolFebridolPanamaxParacetamol (Sandoz)Paracetamol Sandoz PharmaParalginPHARMACY CARE PARACETAMOLWagner Health Paracetamol
Paracetamol	GRP-15198	Tablet 665 mg (modified release)	Oral	APOHEALTH Osteo Relief Paracetamol 665 mgChemists' Own Osteo Relief ParacetamolOsteomol 665 ParacetamolParapane OSTEOPharmacy Action Paracetamol Osteo 665
Paroxetine	GRP-1064	Tablet 20 mg (as hydrochloride)	Oral	APX-ParoxetineAropaxBlooms The Chemist ParoxetineExtine 20Paroxetine GHParoxetine SandozPAROXETINE-WGRPaxtine
Pazopanib	GRP-30177	Tablet 200 mg (as hydrochloride)	Oral	Pazopanib ADVZPazopanib Dr.Reddy’sPazopanib RZVotrient
Pazopanib	GRP-30179	Tablet 200 mg (as hydrochloride)	Oral	Pazopanib ADVZPazopanib Dr.Reddy’sPazopanib RZVotrient
Pazopanib	GRP-30181	Tablet 400 mg (as hydrochloride)	Oral	Pazopanib ADVZPazopanib Dr.Reddy’sPazopanib RZVotrient
Pazopanib	GRP-30183	Tablet 400 mg (as hydrochloride)	Oral	Pazopanib ADVZPazopanib Dr.Reddy’sPazopanib RZVotrient
Pegfilgrastim	GRP-21317	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	PelgrazZiextenzo
Peginterferon alfa-2a	GRP-30048	Injection 135 micrograms in 0.5 mL single use pre-filled syringe (s19A)	Injection	Pegasys (Ireland)
Peginterferon alfa-2a	GRP-30048	Injection 135 micrograms in 0.5 mL single use pre-filled syringe	Injection	Pegasys
Peginterferon alfa-2a	GRP-30049	Injection 180 micrograms in 0.5 mL single use pre-filled syringe (s19A)	Injection	Pegasys (Ireland)
Peginterferon alfa-2a	GRP-30049	Injection 180 micrograms in 0.5 mL single use pre-filled syringe	Injection	Pegasys
Perindopril	GRP-702	Tablet containing perindopril arginine 2.5 mg	Oral	APO-Perindopril ArginineAPX-Perindopril ArginineCoversyl 2.5mgPerindopril Arginine SandozPerindopril Arginine-WGRPREXUM 2.5
Perindopril	GRP-702	Tablet containing perindopril erbumine 2 mg	Oral	APO-PerindoprilPERINDOPRIL-WGRPERISYL
Perindopril	GRP-704	Tablet containing perindopril arginine 5 mg	Oral	APO-Perindopril ArginineAPX-Perindopril ArginineCoversyl 5mgPerindopril Arginine SandozPerindopril Arginine-WGRPREXUM 5
Perindopril	GRP-704	Tablet containing perindopril erbumine 4 mg	Oral	APO-PerindoprilPERINDOPRIL-WGRPERISYL
Perindopril	GRP-706	Tablet containing perindopril arginine 10 mg	Oral	APO-Perindopril ArginineAPX-Perindopril ArginineCoversyl 10mgPerindopril Arginine SandozPerindopril Arginine-WGRPREXUM 10
Perindopril	GRP-706	Tablet containing perindopril erbumine 8 mg	Oral	APO-PerindoprilPERINDOPRIL-WGRPERISYL
Perindopril with amlodipine	GRP-726	Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besilate)	Oral	APO-Perindopril Arginine/Amlodipine 10/10APX-Perindopril Arginine/Amlodipine 10/10Coveram 10/10Perindopril Arginine/Amlodipine-WGR 10/10Reaptan 10/10
Perindopril with amlodipine	GRP-727	Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besilate)	Oral	APO-Perindopril Arginine/Amlodipine 10/5APX-Perindopril Arginine/Amlodipine 10/5Coveram 10/5Perindopril Arginine/Amlodipine-WGR 10/5Reaptan 10/5
Perindopril with amlodipine	GRP-728	Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besilate)	Oral	APO-Perindopril Arginine/Amlodipine 5/10APX-Perindopril Arginine/Amlodipine 5/10Coveram 5/10Perindopril Arginine/Amlodipine-WGR 5/10Reaptan 5/10
Perindopril with amlodipine	GRP-729	Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besilate)	Oral	APO-Perindopril Arginine/Amlodipine 5/5APX-Perindopril Arginine/Amlodipine 5/5Coveram 5/5Perindopril Arginine/Amlodipine-WGR 5/5Reaptan 5/5
Perindopril with indapamide	GRP-1269	Tablet containing perindopril arginine 5 mg with indapamide hemihydrate 1.25 mg	Oral	Coversyl Plus 5mg/1.25mgPrexum Combi 5/1.25
Perindopril with indapamide	GRP-1269	Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg	Oral	APO-Perindopril/IndapamideGenRx Perindopril/ Indapamide 4/1.25PERINDOPRIL/INDAPAMIDE-WGR 4/1.25PERISYL COMBI 4/1.25
Perindopril with indapamide	GRP-21172	Tablet containing perindopril arginine 2.5 mg with indapamide hemihydrate 0.625 mg	Oral	Coversyl Plus LD 2.5mg/0.625mgPREXUM Combi LD 2.5/0.625
Phenobarbital	GRP-30846	Tablet 30 mg	Oral	Phenobarb
Phenobarbital	GRP-30846	Tablet 30 mg (s19A)	Oral	Phenobarbital Tablets, USP 30 mg (Rising Pharmaceuticals, USA)
Pioglitazone	GRP-691	Tablet 15 mg (as hydrochloride)	Oral	ARX-PIOGLITAZONEVexazone
Pioglitazone	GRP-692	Tablet 30 mg (as hydrochloride)	Oral	ARX-PIOGLITAZONEVexazone
Pioglitazone	GRP-693	Tablet 45 mg (as hydrochloride)	Oral	ARX-PIOGLITAZONEVexazone
Pirfenidone	GRP-27836	Tablet 267 mg	Oral	ARX-PirfenidonePirfenidetPirfenidone AmedaPirfenidone Dr.Reddy'sPirfenidone Sandoz
Pirfenidone	GRP-27838	Tablet 801 mg	Oral	ARX-PirfenidonePirfenidetPirfenidone AmedaPirfenidone Dr.Reddy'sPirfenidone Sandoz
Plerixafor	GRP-26590	Injection 24 mg in 1.2 mL	Injection	Plerixafor ARXPLERIXAFOR EUGIA
Posaconazole	GRP-24330	Tablet (modified release) 100 mg	Oral	Pharmacor PosaconazolePosaconazole ARXPOSACONAZOLE DR.REDDY'SPosaconazole JunoPosaconazole SandozPOSACONAZOLE-WGRPOSMED
Pramipexole	GRP-715	Tablet containing pramipexole dihydrochloride monohydrate 1 mg	Oral	APO-PramipexoleSifrolSimipex 1Simpral
Pramipexole	GRP-716	Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms	Oral	APO-PramipexoleSifrolSimipex 0.125Simpral
Pramipexole	GRP-717	Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms	Oral	APO-PramipexoleSifrolSimipex 0.25Simpral
Pramipexole	GRP-20454	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms	Oral	Sifrol ERSIMIPEX XR
Pramipexole	GRP-20456	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms	Oral	Sifrol ERSIMIPEX XR
Pramipexole	GRP-20458	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg	Oral	Sifrol ERSIMIPEX XR
Pramipexole	GRP-20460	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg	Oral	Sifrol ERSIMIPEX XR
Pramipexole	GRP-20462	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg	Oral	Sifrol ERSIMIPEX XR
Pramipexole	GRP-20464	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg	Oral	Sifrol ERSIMIPEX XR
Pramipexole	GRP-20466	Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg	Oral	Sifrol ERSIMIPEX XR
Pravastatin	GRP-1037	Tablet containing pravastatin sodium 10 mg	Oral	APX-PravastatinCholstat 10Lipostat 10PravacholPravastatin SandozPRAVASTATIN-WGR
Pravastatin	GRP-1038	Tablet containing pravastatin sodium 20 mg	Oral	APX-PravastatinCholstat 20Lipostat 20PravacholPravastatin SandozPRAVASTATIN-WGR
Pravastatin	GRP-1039	Tablet containing pravastatin sodium 40 mg	Oral	APX-PravastatinCholstat 40Lipostat 40PravacholPravastatin SandozPRAVASTATIN-WGR
Pravastatin	GRP-1040	Tablet containing pravastatin sodium 80 mg	Oral	APX-PravastatinLipostat 80Pravachol
Praziquantel	GRP-30503	Tablet 600 mg (Korea) (s19A)	Oral	Distocide (Korea)
Praziquantel	GRP-30503	Tablet 600 mg (s19A)	Oral	Praziquantel Tablets, USP 600 mg (Endo, USA)
Prazosin	GRP-908	Capsule 1 mg (as hydrochloride) (S19A)	Oral	Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA)
Prazosin	GRP-908	Tablet 1 mg (as hydrochloride)	Oral	APO-PrazosinMinipress
Prazosin	GRP-909	Tablet 2 mg (as hydrochloride)	Oral	APO-PrazosinMinipress
Prazosin	GRP-910	Tablet 5 mg (as hydrochloride)	Oral	APO-PrazosinMinipress
Prednisolone	GRP-911	Tablet 1 mg	Oral	PanafcortelonePredsolone
Prednisolone	GRP-912	Oral solution 5 mg (as sodium phosphate) per mL, 30 mL	Oral	PredMixRedipred
Prednisone	GRP-917	Tablet 1 mg	Oral	PanafcortPredsone
Pregabalin	GRP-21584	Capsule 25 mg	Oral	APO-PregabalinBTC PregabalinLyricaLyzalonNeuroccordPrebalinPREGABALIN-DRLAPregabalin LupinPregabalin SandozPREGABALIN-WGR
Pregabalin	GRP-21586	Capsule 150 mg	Oral	APO-PregabalinBTC PregabalinLyricaLyzalonNeuroccordPrebalinPREGABALIN-DRLAPregabalin LupinPregabalin SandozPREGABALIN-WGR
Pregabalin	GRP-21588	Capsule 300 mg	Oral	APO-PregabalinBTC PregabalinLyricaLyzalonNeuroccordPrebalinPREGABALIN-DRLAPregabalin LupinPregabalin SandozPREGABALIN-WGR
Pregabalin	GRP-21590	Capsule 75 mg	Oral	APO-PregabalinBTC PregabalinLyricaLyzalonNeuroccordPrebalinPREGABALIN-DRLAPregabalin LupinPregabalin SandozPREGABALIN-WGR
Prochlorperazine	GRP-918	Tablet containing prochlorperazine maleate 5 mg	Oral	APO-ProchlorperazineProCalmProchlorperazine GHProchlorperazine ViatrisPROCHLORPERAZINE-WGRStemetil
Progesterone	GRP-30454	Capsule 200 mg	Vaginal	Progesterone BNM 200Utrogestan
Progesterone	GRP-30474	Capsule 100 mg	Oral	Progesterone ADVZ 100PROGESTERONE-APXPrometrium
Propranolol	GRP-16357	Tablet containing propranolol hydrochloride 10 mg	Oral	APO-PropranololDeralin 10InderalPROPRANOLOL-WGR
Propranolol	GRP-16359	Tablet containing propranolol hydrochloride 40 mg	Oral	APO-PropranololDeralin 40InderalPROPRANOLOL-WGR
Quetiapine	GRP-1275	Tablet 100 mg (as fumarate)	Oral	APX-QUETIAPINEBlooms The Chemist QuetiapineKaptanPharmacor Quetiapine 100Quetia 100Quetiapine RBXQuetiapine Sandoz PharmaQUETIAPINE-WGRSeroquelSyquet
Quetiapine	GRP-1276	Tablet 200 mg (as fumarate)	Oral	APX-QUETIAPINEBlooms The Chemist QuetiapineKaptanPharmacor Quetiapine 200Quetia 200Quetiapine RBXQuetiapine Sandoz PharmaQUETIAPINE-WGRSeroquelSyquet
Quetiapine	GRP-1277	Tablet 25 mg (as fumarate)	Oral	APX-QUETIAPINEBlooms The Chemist QuetiapineKaptanPharmacor Quetiapine 25Quetia 25Quetiapine RBXQuetiapine Sandoz PharmaQUETIAPINE-WGRSeroquelSyquet
Quetiapine	GRP-1278	Tablet 300 mg (as fumarate)	Oral	APX-QUETIAPINEBlooms The Chemist QuetiapineKaptanPharmacor Quetiapine 300Quetia 300Quetiapine RBXQuetiapine Sandoz PharmaQUETIAPINE-WGRSeroquelSyquet
Quetiapine	GRP-20641	Tablet (modified release) 200 mg (as fumarate)	Oral	APX-Quetiapine XRQuetia XRQUETIAPINE-AS XRQuetiapine Sandoz XRSeroquel XRTevatiapine XR
Quetiapine	GRP-20643	Tablet (modified release) 300 mg (as fumarate)	Oral	APX-Quetiapine XRQuetia XRQUETIAPINE-AS XRQuetiapine Sandoz XRSeroquel XRTevatiapine XR
Quetiapine	GRP-20645	Tablet (modified release) 400 mg (as fumarate)	Oral	APX-Quetiapine XRQuetia XRQUETIAPINE-AS XRQuetiapine Sandoz XRSeroquel XRTevatiapine XR
Quetiapine	GRP-20730	Tablet (modified release) 50 mg (as fumarate)	Oral	APX-Quetiapine XRQuetia XRQUETIAPINE-AS XRQuetiapine Sandoz XRSeroquel XRTevatiapine XR
Quetiapine	GRP-21098	Tablet (modified release) 150 mg (as fumarate)	Oral	APX-Quetiapine XRQuetia XRQuetiapine Sandoz XRSeroquel XRTevatiapine XR
Rabeprazole	GRP-6757	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	APO-RabeprazoleParbezolRabeprazole MylanRabeprazole SandozRabeprazole SUNRABEPRAZOLE-WGRZabep
Rabeprazole	GRP-6759	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	APO-RabeprazoleParbezolRabeprazole SandozRabeprazole ViatrisRABEPRAZOLE-WGR
Raloxifene	GRP-15178	Tablet containing raloxifene hydrochloride 60 mg	Oral	EvistaFixta 60RALOVISTARaloxifene GH
Ramipril	GRP-1009	Capsule 10 mg	Oral	APO-RamiprilAPX-RamiprilPrilaceRamipril SandozRAMIPRIL-WGRTritace 10 mgTryzan Caps 10
Ramipril	GRP-1009	Tablet 10 mg	Oral	APO-RamiprilRamipril SandozRAMIPRIL TABS-WGRRamipril ViatrisTritace
Ramipril	GRP-1012	Capsule 1.25 mg	Oral	Tryzan Caps 1.25
Ramipril	GRP-1012	Tablet 1.25 mg	Oral	PrilaceRamipril SandozRamipril ViatrisRAMIPRIL-WGR
Ramipril	GRP-1014	Capsule 2.5 mg	Oral	APO-RamiprilTryzan Caps 2.5
Ramipril	GRP-1014	Tablet 2.5 mg	Oral	APO-RamiprilPrilaceRamipril SandozRamipril ViatrisRAMIPRIL-WGRRamipril WinthropTritace 2.5 mg
Ramipril	GRP-1015	Capsule 5 mg	Oral	APO-RamiprilTryzan Caps 5
Ramipril	GRP-1015	Tablet 5 mg	Oral	APO-RamiprilPrilaceRamipril SandozRamipril ViatrisRAMIPRIL-WGRRamipril WinthropTritace 5 mg
Ranibizumab	GRP-16030	Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe	Injection	Lucentis
Ranibizumab	GRP-16030	Solution for intravitreal injection 2.3 mg in 0.23 mL	Injection	Lucentis
Ranitidine	GRP-919	Tablet 150 mg (as hydrochloride)	Oral	APO-RanitidineZantac 150
Ranitidine	GRP-920	Tablet 300 mg (as hydrochloride)	Oral	APO-RanitidineZantac 300
Rasagiline	GRP-22779	Tablet 1 mg (as mesilate)	Oral	AlzirasAzilectPharmacor RasagilineRasagiline LupinRasagiline-Teva
Riluzole	GRP-6761	Tablet 50 mg	Oral	Pharmacor RiluzoleRilutekRiluzole Sandoz
Risedronic acid	GRP-1289	Tablet containing risedronate sodium 35 mg	Oral	APO-RisedronateRisedronate SandozRISEDRONATE-WGR
Risedronic acid	GRP-6695	Tablet containing risedronate sodium 150 mg	Oral	Actonel Once-a-MonthAPO-RisedronateRisedronate Way
Risperidone	GRP-1089	Tablet 0.5 mg	Oral	APO-RisperidoneOzidalRispaRisperidone SandozRisperniaRixadone
Risperidone	GRP-1090	Tablet 1 mg	Oral	APO-RisperidoneOzidalRispaRisperidone SandozRisperniaRixadone
Risperidone	GRP-1091	Tablet 2 mg	Oral	APO-RisperidoneOzidalRispaRisperidone SandozRisperniaRixadone
Risperidone	GRP-1092	Tablet 3 mg	Oral	APO-RisperidoneOzidalRispaRisperidone SandozRisperniaRixadone
Risperidone	GRP-1093	Tablet 4 mg	Oral	APO-RisperidoneRispaRisperidone SandozRisperniaRixadone
Risperidone	GRP-23942	Oral solution 1 mg per mL, 100 mL	Oral	RisperdalRisperidone LupinRixadone
Rituximab	GRP-23377	Solution for I.V. infusion 100 mg in 10 mL	Injection	RiximyoRuxienceTruxima
Rituximab	GRP-23378	Solution for I.V. infusion 500 mg in 50 mL	Injection	RiximyoRuxienceTruxima
Rivaroxaban	GRP-29128	Tablet 10 mg	Oral	APO-RivaroxabanARX-Rivaroxaban 10iXarolaRivareltoRivaroxaban Dr.Reddy'sRivaroxaban LupinRivaroxaban SandozRivaroxaban-TevaRIVAXIBRivoxaTROXAXareltoXAREMED
Rivaroxaban	GRP-29130	Capsule 15 mg	Oral	Relaban
Rivaroxaban	GRP-29130	Tablet 15 mg	Oral	APO-RivaroxabanARX-Rivaroxaban 15iXarolaRivareltoRivaroxaban Dr.Reddy'sRivaroxaban LupinRivaroxaban SandozRivaroxaban-TevaRIVAXIBRivoxaTROXAXareltoXAREMED
Rivaroxaban	GRP-29132	Capsule 20 mg	Oral	Relaban
Rivaroxaban	GRP-29132	Tablet 20 mg	Oral	APO-RivaroxabanARX-Rivaroxaban 20iXarolaRivareltoRivaroxaban Dr.Reddy'sRivaroxaban LupinRivaroxaban SandozRivaroxaban-TevaRIVAXIBRivoxaTROXAXareltoXAREMED
Rivaroxaban	GRP-29134	Tablet 15 mg	Oral	APO-RivaroxabanARX-Rivaroxaban 15RivareltoRivaroxaban LupinRivaroxaban SandozRivaroxaban-TevaRIVAXIBRivoxaXareltoXAREMED
Rivaroxaban	GRP-29137	Tablet 2.5 mg	Oral	APO-RivaroxabanRivaroxaban LupinRivaroxaban-TevaRIVOXAXarelto
Rivaroxaban	GRP-29331	Tablet 10 mg	Oral	APO-RivaroxabanARX-Rivaroxaban 10RIVAXIBXareltoXAREMED
Rizatriptan	GRP-17557	Tablet (orally disintegrating) 10 mg (as benzoate)	Oral	APO-RIZATRIPTAN ODTRIXALTRizatriptan-AuRizatriptan ODT ViatrisRIZATRIPTAN ODT-WGR
Rizatriptan	GRP-17557	Wafer 10 mg (as benzoate)	Oral	MaxaltRizatriptan Wafers-10mg
Rosuvastatin	GRP-12788	Tablet 40 mg (as calcium)	Oral	APO-ROSUVASTATINAPX-RosuvastatinBlooms RosuvastatinCavstatCrestorCrosuva 40Pharmacor Rosuvastatin 40Rosuvastatin LupinRosuvastatin RBXRosuvastatin SandozROSUVASTATIN-WGR
Rosuvastatin	GRP-12790	Tablet 20 mg (as calcium)	Oral	APO-ROSUVASTATINAPX-RosuvastatinBlooms RosuvastatinCavstatCrestorCrosuva 20Pharmacor Rosuvastatin 20Rosuvastatin LupinRosuvastatin RBXRosuvastatin SandozROSUVASTATIN-WGR
Rosuvastatin	GRP-12792	Tablet 10 mg (as calcium)	Oral	APO-ROSUVASTATINAPX-RosuvastatinBlooms RosuvastatinCavstatCrestorCrosuva 10Pharmacor Rosuvastatin 10Rosuvastatin LupinRosuvastatin RBXRosuvastatin SandozROSUVASTATIN-WGR
Rosuvastatin	GRP-12794	Tablet 5 mg (as calcium)	Oral	APO-ROSUVASTATINAPX-RosuvastatinBlooms RosuvastatinCavstatCrestorCrosuva 5Pharmacor Rosuvastatin 5Rosuvastatin LupinRosuvastatin RBXRosuvastatin SandozROSUVASTATIN-WGR
Roxithromycin	GRP-1023	Tablet 150 mg	Oral	APX-RoxithromycinRoxar 150Roxithromycin SandozROXITHROMYCIN-WGR
Roxithromycin	GRP-1024	Tablet 300 mg	Oral	APX-RoxithromycinRoxar 300Roxithromycin SandozROXITHROMYCIN-WGR
Sacubitril with valsartan	GRP-29537	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	EntrestoOmtraloPharmacor Sacubitril/ValsartanSacubitril/Valsartan AlphapharmSacubitril/Valsartan Lupin 24/26SACUBITRIL/VALSARTAN-WGRValtresto
Sacubitril with valsartan	GRP-29539	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	EntrestoOmtraloPharmacor Sacubitril/ValsartanSacubitril/Valsartan AlphapharmSacubitril/Valsartan Lupin 49/51SACUBITRIL/VALSARTAN-WGRValtresto
Sacubitril with valsartan	GRP-29541	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	EntrestoOmtraloPharmacor Sacubitril/ValsartanSacubitril/Valsartan AlphapharmSacubitril/Valsartan Lupin 97/103SACUBITRIL/VALSARTAN-WGRValtresto
Safinamide	GRP-30154	Tablet 100 mg	Oral	ARX-SafinamideXadagoXAFIMED
Safinamide	GRP-30156	Tablet 50 mg	Oral	ARX-SafinamideXadagoXAFIMED
Salbutamol	GRP-922	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20	Inhalation	Ventolin Nebules
Salbutamol	GRP-922	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20 (s19A)	Inhalation	Salbutamol (as sulfate) (Accord, UK)
Salbutamol	GRP-922	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30	Inhalation	Salbutamol Cipla
Salbutamol	GRP-923	Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)	Inhalation by mouth	Asmol CFC-Free with dose counterVentolin CFC-Free with dose counterZempreon CFC-Free with dose counter
Selpercatinib	GRP-30794	Capsule 40 mg	Oral	Retevmo
Selpercatinib	GRP-30794	Tablet 40 mg	Oral	Retevmo
Selpercatinib	GRP-30796	Capsule 80 mg	Oral	Retevmo
Selpercatinib	GRP-30796	Tablet 80 mg	Oral	Retevmo
Sertraline	GRP-1066	Tablet 100 mg (as hydrochloride)	Oral	APO-SertralineBlooms The Chemist SertralineEleva 100Sertra 100Sertraline generichealthSertraline SandozSERTRALINE-WGRSetronaZoloft
Sertraline	GRP-1067	Tablet 50 mg (as hydrochloride)	Oral	APO-SertralineBlooms The Chemist SertralineEleva 50Sertra 50Sertraline generichealthSertraline SandozSERTRALINE-WGRSetronaZoloft
Sevelamer	GRP-23500	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMERSevelamer Lupin
Sevelamer	GRP-23500	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel
Sildenafil	GRP-14741	Tablet 20 mg (as citrate)	Oral	SILDATIO PHTSildenafil PHT APOTEXSILDENAFIL PHT ARXSildenafil Sandoz PHT 20
Simvastatin	GRP-924	Tablet 10 mg	Oral	APO-SimvastatinSimvar 10Simvastatin SandozSIMVASTATIN-WGRZimstat
Simvastatin	GRP-925	Tablet 20 mg	Oral	APO-SimvastatinLipex 20Simvar 20Simvastatin SandozSIMVASTATIN-WGRZimstatZocor
Simvastatin	GRP-926	Tablet 40 mg	Oral	APO-SimvastatinLipex 40Simvar 40Simvastatin SandozSIMVASTATIN-WGRZimstatZocor
Simvastatin	GRP-927	Tablet 5 mg	Oral	Simvastatin SandozZimstat
Simvastatin	GRP-928	Tablet 80 mg	Oral	APO-SimvastatinSimvar 80Simvastatin SandozSIMVASTATIN-WGRZimstat
Sitagliptin	GRP-26468	Tablet 100 mg	Oral	JanuviaSitagliptin LupinSitagliptin MylanSitagliptin Sandoz PharmaSitagliptin SUNSitagloXelevia
Sitagliptin	GRP-26470	Tablet 25 mg	Oral	JanuviaSitagliptin LupinSitagliptin MylanSitagliptin Sandoz PharmaSitagliptin SUNSitagloXelevia
Sitagliptin	GRP-26472	Tablet 50 mg	Oral	JanuviaSitagliptin LupinSitagliptin MylanSitagliptin Sandoz PharmaSitagliptin SUNSitagloXelevia
Sitagliptin with metformin	GRP-26346	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/1000JanumetSITAGLIPTIN/METFORMIN 50/1000 SUNSitagliptin/Metformin Mylan 50/1000Sitagliptin/Metformin SandozSITAGLO-METVelmetia
Sitagliptin with metformin	GRP-26348	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/500JanumetSITAGLIPTIN/METFORMIN 50/500 SUNSitagliptin/Metformin Mylan 50/500Sitagliptin/Metformin SandozSITAGLO-METVelmetia
Sitagliptin with metformin	GRP-26350	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/850JanumetSITAGLIPTIN/METFORMIN 50/850 SUNSitagliptin/Metformin Mylan 50/850Sitagliptin/Metformin SandozSITAGLO-METVelmetia
Sitagliptin with metformin	GRP-27961	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet XRSitagliptin/Metformin Sandoz XRSitagliptin/Metformin XR KNDSitagliptin/Metformin XR Mylan
Sitagliptin with metformin	GRP-27963	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet XRSitagliptin/Metformin Sandoz XRSitagliptin/Metformin XR KNDSitagliptin/Metformin XR Mylan
Sotalol	GRP-937	Tablet containing sotalol hydrochloride 160 mg	Oral	APX-SotalolCardolSolavertSotacorSotalol SandozSOTALOL-WGR
Sotalol	GRP-938	Tablet containing sotalol hydrochloride 80 mg	Oral	APX-SotalolCardolSolavertSotacorSotalol SandozSOTALOL-WGR
Spironolactone	GRP-939	Tablet 100 mg	Oral	AldactoneSpiractin 100Spironolactone Viatris 100
Spironolactone	GRP-940	Tablet 25 mg	Oral	AldactoneSpiractin 25Spironolactone Viatris 25
Sulfasalazine	GRP-942	Tablet 500 mg (enteric coated)	Oral	Pyralin ENSalazopyrin-EN
Sumatriptan	GRP-1240	Tablet 50 mg (as succinate)	Oral	APO-SumatriptanImigranIptamPharmacor Sumatriptan 50Sumagraine Migraine ReliefSumatranSumatriptan generichealthSumatriptan SandozSUMATRIPTAN-WGR
Sumatriptan	GRP-1240	Tablet (fast disintegrating) 50 mg (as succinate)	Oral	Imigran FDT
Sunitinib	GRP-25517	Capsule 12.5 mg	Oral	Sunitinib SandozSutent
Sunitinib	GRP-25518	Capsule 25 mg	Oral	ARX-SunitinibSunitinib SandozSutent
Sunitinib	GRP-25519	Capsule 37.5 mg	Oral	ARX-SunitinibSunitinib SandozSutent
Sunitinib	GRP-25520	Capsule 50 mg	Oral	ARX-SunitinibSunitinib SandozSutent
Tacrolimus	GRP-1188	Capsule 1 mg	Oral	PacrolimPharmacor Tacrolimus 1PrografTacrografTacrolimus Sandoz
Tacrolimus	GRP-1189	Capsule 5 mg	Oral	Pharmacor Tacrolimus 5PrografTacrografTacrolimus Sandoz
Tacrolimus	GRP-1298	Capsule 0.5 mg	Oral	PacrolimPharmacor Tacrolimus 0.5PrografTacrografTacrolimus Sandoz
Tacrolimus	GRP-20828	Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XLTacrolimus XR Sandoz
Tacrolimus	GRP-20830	Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XLTacrolimus XR Sandoz
Tacrolimus	GRP-20832	Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XLTacrolimus XR Sandoz
Tacrolimus	GRP-28585	Capsule 3 mg (once daily prolonged release)	Oral	ADVAGRAF XLTacrolimus XR Sandoz
Tadalafil	GRP-24251	Tablet 20 mg	Oral	AdcircaTadalcaTADALIS 20
Tamoxifen	GRP-943	Tablet 20 mg (as citrate)	Oral	Genox 20GenRx TamoxifenNolvadex-DTamosinTamoxifen Sandoz
Telmisartan	GRP-14911	Tablet 40 mg	Oral	APO-TelmisartanMicardisMizartPharmacor Telmisartan 40Telmisartan SandozTELMISARTAN-WGRTeltartan
Telmisartan	GRP-14913	Tablet 80 mg	Oral	APO-TelmisartanMicardisMizartPharmacor Telmisartan 80Telmisartan SandozTELMISARTAN-WGRTeltartan
Telmisartan with amlodipine	GRP-14671	Tablet 40 mg-5 mg (as besilate)	Oral	ARX-Telmisartan/AmlodipineTelmisartan/Amlodipine ViatrisTwilem 40/5
Telmisartan with amlodipine	GRP-14673	Tablet 40 mg-10 mg (as besilate)	Oral	ARX-Telmisartan/AmlodipineTelmisartan/Amlodipine ViatrisTwilem 40/10
Telmisartan with amlodipine	GRP-14675	Tablet 80 mg-5 mg (as besilate)	Oral	ARX-Telmisartan/AmlodipineTelmisartan/Amlodipine ViatrisTwilem 80/5
Telmisartan with amlodipine	GRP-14677	Tablet 80 mg-10 mg (as besilate)	Oral	ARX-Telmisartan/AmlodipineTelmisartan/Amlodipine ViatrisTwilem 80/10
Telmisartan with hydrochlorothiazide	GRP-13702	Tablet 40 mg-12.5 mg	Oral	APO-Telmisartan HCTZ 40/12.5Micardis Plus 40/12.5 mgMizart HCT 40/12.5 mgTelmisartan/HCT SandozTELMISARTAN HCTZ-WGR 40/12.5Teltartan HCT 40/12.5
Telmisartan with hydrochlorothiazide	GRP-13704	Tablet 80 mg-12.5 mg	Oral	APO-Telmisartan HCTZ 80/12.5Micardis Plus 80/12.5 mgMizart HCT 80/12.5 mgTelmisartan/HCT SandozTELMISARTAN HCTZ-WGR 80/12.5Teltartan HCT 80/12.5
Telmisartan with hydrochlorothiazide	GRP-13706	Tablet 80 mg-25 mg	Oral	APO-Telmisartan HCTZ 80/25Micardis Plus 80/25 mgMizart HCT 80/25 mgTelmisartan/HCT SandozTELMISARTAN HCTZ-WGR 80/25Teltartan HCT 80/25
Temazepam	GRP-944	Tablet 10 mg	Oral	APO-TemazepamNormisonTemazeTEMAZEPAM-WGRTemtabs
Temozolomide	GRP-1247	Capsule 100 mg	Oral	APO-TemozolomideTemizole 100Temozolomide Juno
Temozolomide	GRP-1248	Capsule 140 mg	Oral	APO-TemozolomideTemizole 140Temozolomide Juno
Temozolomide	GRP-1249	Capsule 20 mg	Oral	APO-TemozolomideTemizole 20Temozolomide Juno
Temozolomide	GRP-1250	Capsule 250 mg	Oral	APO-TemozolomideTemizole 250Temozolomide Juno
Temozolomide	GRP-1251	Capsule 5 mg	Oral	APO-TemozolomideTemizole 5Temozolomide Juno
Temozolomide	GRP-12787	Capsule 180 mg	Oral	APO-TemozolomideTemozolomide Juno
Tenofovir	GRP-21602	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	TENOFOVIR ARXTenofovir Sandoz
Tenofovir	GRP-21602	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Viatris
Tenofovir	GRP-21602	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH
Tenofovir with emtricitabine	GRP-21607	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200TENOFOVIR/EMTRICITABINE 300/200 APXTENOFOVIR/EMTRICITABINE 300/200 ARXTenofovir/Emtricitabine Sandoz Pharma 300/200
Tenofovir with emtricitabine	GRP-21607	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200
Tenofovir with emtricitabine	GRP-21607	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200
Tenofovir with emtricitabine and efavirenz	GRP-23126	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg (s19A)	Oral	Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablet 600 mg/200 mg/300 mg (Camber, USA)
Tenofovir with emtricitabine and efavirenz	GRP-23126	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg	Oral	Tenofovir Disoproxil Emtricitabine Efavirenz Viatris 300/200/600
Terbinafine	GRP-1222	Tablet 250 mg (as hydrochloride)	Oral	APO-TerbinafineTamsilTerbinafine-DRLATerbinafine SandozTERBINAFINE-WGRTinasil
Teriflunomide	GRP-23018	Tablet 14 mg	Oral	APO-TERIFLUNOMIDEPharmacor TeriflunomideTERIFLAGIOTeriflunomide Dr.Reddy'sTeriflunomide GHTeriflunomide SandozTerimide
Teriparatide	GRP-25486	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge	Injection	Ritosa
Teriparatide	GRP-25486	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen	Injection	Teriparatide LupinTerrosa
Testosterone	GRP-28619	I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL	Injection	GonadronReandron 1000REJUNON 1000Testosterone ADVZ 1000
Tetrabenazine	GRP-26927	Tablet 25 mg	Oral	iNova Pharmaceuticals (Australia) Pty LtdTetrabenazine SUN
Ticagrelor	GRP-29339	Tablet 90 mg	Oral	ARX-TICAGRELORBrilintaPharmacor TicagrelorTicagrelor Dr.Reddy'sTicagrelor LupinTicagrelor SandozTicagrelor SUNTicagrelor ViatrisTICALORTirela
Timolol	GRP-950	Eye drops 5 mg (as maleate) per mL, 5 mL	Application to the eye	TIMOEYETimoptol
Tiotropium	GRP-23120	Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)	Inhalation by mouth	Braltus
Tiotropium	GRP-23120	Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)	Inhalation by mouth	Spiriva
Tiotropium	GRP-23120	Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)	Inhalation by mouth	Tiotropium Lupin
Tirofiban	GRP-14753	Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL	Injection	AggrastatTirofiban Juno
Tobramycin	GRP-20821	Solution for inhalation 300 mg in 5 mL	Inhalation	TobiTOBRAMYCIN SUNTOBRAMYCIN WKT
Tocilizumab	GRP-25598	Concentrate for injection 200 mg in 10 mL	Injection	ActemraAvtozma
Tocilizumab	GRP-25599	Concentrate for injection 400 mg in 20 mL	Injection	ActemraAvtozma
Tocilizumab	GRP-25600	Concentrate for injection 80 mg in 4 mL	Injection	ActemraAvtozma
Tocilizumab	GRP-31057	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPenAvtozma
Tocilizumab	GRP-31058	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous InjectionAvtozma
Tolvaptan	GRP-29515	Pack containing 28 tablets 15 mg and 28 tablets 45 mg	Oral	JinarcTolvaptan Lupin
Tolvaptan	GRP-29517	Pack containing 28 tablets 30 mg and 28 tablets 60 mg	Oral	JinarcTolvaptan Lupin
Tolvaptan	GRP-29519	Pack containing 28 tablets 30 mg and 28 tablets 90 mg	Oral	JinarcTolvaptan Lupin
Topiramate	GRP-1165	Tablet 100 mg	Oral	APO-TopiramateEpiramax 100RBX TopiramateTamateTopiramate SandozTOPIRAMATE-WGR
Topiramate	GRP-1166	Tablet 200 mg	Oral	APO-TopiramateEpiramax 200RBX TopiramateTamateTopiramate SandozTOPIRAMATE-WGR
Topiramate	GRP-1167	Tablet 25 mg	Oral	APO-TopiramateEpiramax 25RBX TopiramateTamateTopiramate SandozTOPIRAMATE-WGR
Topiramate	GRP-1168	Tablet 50 mg	Oral	APO-TopiramateEpiramax 50RBX TopiramateTamateTopiramate SandozTOPIRAMATE-WGR
Tramadol	GRP-1279	Capsule containing tramadol hydrochloride 50 mg	Oral	APO-TramadolTramadol SandozTRAMADOL-WGRTramalTramedoZydol
Tramadol	GRP-1280	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol ANTramadol SandozTramal 100
Tramadol	GRP-1281	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	APO-Tramadol SRTramadol Sandoz SRTramadol SR generichealthTRAMADOL-WGR SRTramal SR 100Tramedo SRZydol SR 100
Tramadol	GRP-1282	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	APO-Tramadol SRTramadol Sandoz SRTramadol SR generichealthTRAMADOL-WGR SRTramal SR 150Tramedo SRZydol SR 150
Tramadol	GRP-1283	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	APO-Tramadol SRTramadol Sandoz SRTramadol SR generichealthTRAMADOL-WGR SRTramal SR 200Tramedo SRZydol SR 200
Trandolapril	GRP-1097	Capsule 1 mg	Oral	Dolapril 1GoptenTranalphaTrandolapril Viatris
Trandolapril	GRP-1098	Capsule 2 mg	Oral	Dolapril 2GoptenTranalphaTrandolapril Viatris
Trandolapril	GRP-1099	Capsule 4 mg	Oral	Dolapril 4GoptenTranalphaTrandolapril Viatris
Trandolapril	GRP-1100	Capsule 500 micrograms	Oral	Dolapril 0.5GoptenTranalphaTrandolapril Viatris
Tranexamic acid	GRP-21466	Tablet 500 mg	Oral	APO-Tranexamic AcidCyklokapronTranexamic Acid LupinTranexamic Acid Waymade
Tranylcypromine	GRP-30191	Tablet 10 mg (as sulfate)	Oral	ParnateTRANYLMED
Triamcinolone	GRP-952	Cream containing triamcinolone acetonide 200 micrograms per g, 100 g	Application	Aristocort 0.02%Tricortone
Triamcinolone	GRP-953	Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g	Application	Aristocort 0.02%Tricortone
Triamcinolone with neomycin, gramicidin and nystatin	GRP-954	Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL	Application to the ear	Kenacomb OticOtocomb Otic
Triamcinolone with neomycin, gramicidin and nystatin	GRP-955	Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g	Application to the ear	Kenacomb OticOtocomb Otic
Trientine	GRP-28272	Capsule containing trientine dihydrochloride 250 mg (equivalent to 166.7 mg trientine)	Oral	Trientine Dr. Reddy'sTrientine Waymade
Trimethoprim	GRP-956	Tablet 300 mg	Oral	AlprimTrimethoprim ViatrisTRIMETHOPRIM-WGRTriprim
Trimethoprim with sulfamethoxazole	GRP-957	Tablet 160 mg-800 mg	Oral	Bactrim DSResprim ForteSeptrin Forte
Ursodeoxycholic acid	GRP-16053	Capsule 250 mg	Oral	APO-Ursodeoxycholic acidUrsodox GHUrsofalkUrsosan
Ursodeoxycholic acid	GRP-29389	Capsule 500 mg	Oral	Ursodox GH
Ursodeoxycholic acid	GRP-29389	Tablet 500 mg	Oral	ARX-URSODEOXYCHOLIC ACIDUrsofalk
Ustekinumab	GRP-29848	Solution for I.V. infusion 130 mg in 26 mL	Injection	StelaraSteqeymaWezlana
Ustekinumab	GRP-29850	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	StelaraSteqeymaWezlana
Ustekinumab	GRP-30838	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	SteqeymaWezlana
Ustekinumab	GRP-30839	Injection 45 mg in 0.5 mL	Injection	StelaraWezlana
Valaciclovir	GRP-1140	Tablet 500 mg (as hydrochloride)	Oral	APX-ValaciclovirVaclovirValaciclovir SandozVALACICLOVIR-WGRValtrexZelitrex
Valaciclovir	GRP-1141	Tablet 500 mg (as hydrochloride)	Oral	APX-ValaciclovirValaciclovir RBXValtrex
Valaciclovir	GRP-1142	Tablet 500 mg (as hydrochloride)	Oral	APX-ValaciclovirShilova 500VaclovirValaciclovir RBXValaciclovir SandozValaciclovir SZVALACICLOVIR-WGRValtrexZelitrex
Valaciclovir	GRP-1143	Tablet 500 mg (as hydrochloride)	Oral	APX-ValaciclovirVaclovirValaciclovir RBXValaciclovir SandozVALACICLOVIR-WGRValtrexZelitrex
Valganciclovir	GRP-21612	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir SandozValganciclovir Viatris
Valproic acid	GRP-935	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	APO-Sodium ValproateEpilim ECSodium Valproate SandozValpro EC 200Valproate Winthrop EC 200
Valproic acid	GRP-936	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	APO-Sodium ValproateEpilim ECSodium Valproate SandozValpro EC 500Valproate Winthrop EC 500
Valsartan	GRP-14932	Tablet 40 mg	Oral	DilartDiovan
Valsartan	GRP-14934	Tablet 80 mg	Oral	DilartDiovan
Valsartan	GRP-14936	Tablet 160 mg	Oral	DilartDiovan
Valsartan	GRP-14938	Tablet 320 mg	Oral	DilartDiovan
Valsartan with hydrochlorothiazide	GRP-15182	Tablet 160 mg-12.5 mg	Oral	Co-Diovan 160/12.5Dilart HCT 160/12.5
Valsartan with hydrochlorothiazide	GRP-15184	Tablet 320 mg-12.5 mg	Oral	Co-Diovan 320/12.5Dilart HCT 320/12.5
Valsartan with hydrochlorothiazide	GRP-15186	Tablet 320 mg-25 mg	Oral	Co-Diovan 320/25Dilart HCT 320/25
Valsartan with hydrochlorothiazide	GRP-16253	Tablet 80 mg-12.5 mg	Oral	Co-Diovan 80/12.5Dilart HCT 80/12.5
Valsartan with hydrochlorothiazide	GRP-16255	Tablet 160 mg-25 mg	Oral	Co-Diovan 160/25Dilart HCT 160/25
Vancomycin	GRP-958	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin JunoVANCOMYCIN MEDSURGEVancomycin Viatris
Vancomycin	GRP-959	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin JunoVANCOMYCIN MEDSURGEVancomycin Viatris
Vancomycin	GRP-26872	Capsule 125 mg (125,000 I.U.) (as hydrochloride)	Oral	VancocinVancomycin BNM 125mgVANCOR
Vancomycin	GRP-26875	Capsule 250 mg (250,000 I.U.) (as hydrochloride)	Oral	VancocinVancomycin BNM 250mgVANCOR
Varenicline	GRP-26236	Tablet 1 mg	Oral	PHARMACOR VARENICLINEVARENAPIXVarenicline LupinVarenicline SandozVarenicline ViatrisVASSIX
Varenicline	GRP-27902	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	PHARMACOR VARENICLINEVARENAPIXVarenicline LupinVarenicline SandozVarenicline ViatrisVASSIX
Venlafaxine	GRP-1152	Capsule (modified release) 150 mg (as hydrochloride)	Oral	APO-Venlafaxine XRBTC Venlafaxine XREfexor-XRElaxine SR 150Enlafax-XRSandoz Venlafaxine XRVenlafaxine generichealth XRVENLAFAXINE XR-WGR
Venlafaxine	GRP-1153	Capsule (modified release) 37.5 mg (as hydrochloride)	Oral	Efexor-XRElaxine SR 37.5VENLAFAXINE XR-WGR
Venlafaxine	GRP-1154	Capsule (modified release) 75 mg (as hydrochloride)	Oral	APO-Venlafaxine XRBTC Venlafaxine XREfexor-XRElaxine SR 75Enlafax-XRSandoz Venlafaxine XRVenlafaxine generichealth XRVENLAFAXINE XR-WGR
Verapamil	GRP-960	Tablet containing verapamil hydrochloride 180 mg (sustained release)	Oral	Cordilox 180 SRIsoptin 180 SR
Verapamil	GRP-961	Tablet containing verapamil hydrochloride 240 mg (sustained release)	Oral	Cordilox SRIsoptin SR
Verapamil	GRP-963	Tablet containing verapamil hydrochloride 80 mg	Oral	Anpec 80Isoptin
Vildagliptin with metformin	GRP-30326	Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/1000Galvumet 50/1000
Vildagliptin with metformin	GRP-30328	Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/500Galvumet 50/500
Vildagliptin with metformin	GRP-30330	Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/850Galvumet 50/850
Voriconazole	GRP-17714	Tablet 50 mg	Oral	Voriconazole SandozVttackVzole
Voriconazole	GRP-17716	Tablet 200 mg	Oral	Voriconazole SandozVttackVzole
Ziprasidone	GRP-14015	Capsule 20 mg (as hydrochloride)	Oral	ZeldoxZiprasidone GHZIPROX
Ziprasidone	GRP-14017	Capsule 40 mg (as hydrochloride)	Oral	ZeldoxZiprasidone GHZIPROX
Ziprasidone	GRP-14019	Capsule 60 mg (as hydrochloride)	Oral	ZeldoxZiprasidone GHZIPROX
Ziprasidone	GRP-14021	Capsule 80 mg (as hydrochloride)	Oral	ZeldoxZiprasidone GHZIPROX
Zoledronic acid	GRP-17546	Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL	Injection	AclastaOsteovanZoledastaZoledronate-RDY 5
Zoledronic acid	GRP-17556	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	APO-Zoledronic AcidDEZTRONZoledronate-DRLA 4Zoledronic Acid AccordZometa
Zolmitriptan	GRP-13889	Tablet 2.5 mg	Oral	APO-ZolmitriptanZoltripZomig

Schedule 6 · General statement for drugs for the treatment of hepatitis C

Note: See the definition of General statement for drugs for the treatment of hepatitis C in section 5.

1Criteria for eligibility for drugs for the treatment of chronic hepatitis C#

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(a)the patient is treated by a medical practitioner or authorised nurse practitioner who:

(i)is experienced in the treatment of patients with chronic hepatitis C infection; or

(ii)is treating the patient in consultation with:

(A)a gastroenterologist; or

(B)a hepatologist; or

(C)an infectious diseases physician; and

(b)the patient has been assessed by the treating practitioner in accordance with clause 2.

2Assessment of patient#

For the purposes of paragraph 1(b), the patient has been assessed in accordance with this clause if the treating practitioner has:

(a)documented in the patient’s medical records:

(i)repeat test results showing the patient is antibody to hepatitis C virus (anti-HCV) positive; and

(ii)a test result showing the patient is hepatitis C virus ribonucleic acid (RNA) positive; and

(iii)if known, evidence of the patient’s hepatitis C virus genotype; and

(b)chosen a treatment regimen listed for the patient in clause 3; and

(c)collected the following information:

(i)whether the patient is cirrhotic or non-cirrhotic;

(ii)details of the previous treatment regimen, if the patient has previously failed a treatment with a regimen containing an NS5A inhibitor and the chosen treatment regimen is treatment with:

(A)sofosbuvir with velpatasvir and voxilaprevir; or

(B)glecaprevir with pibrentasvir.

3Treatment regimens#

For the purposes of paragraph 2(b), the treatment regimens for a kind of patient mentioned in column 1 of an item in the following table are the regimens listed in column 2 of the item.

Hepatitis C treatment regimens
	Column 1	Column 2
Item	Kind of patient	Treatment regimens
1	Patient:(a) with any genotype; and(b) who is treatment naïve; and(c) who is non-cirrhotic	Either of the following:(a) sofosbuvir with velpatasvir for 12 weeks;(b) glecaprevir with pibrentasvir for 8 weeks
2	Patient:(a) with any genotype; and(b) who is treatment experienced; and(c) who is non-cirrhotic	Any of the following:(a) sofosbuvir with velpatasvir for 12 weeks;(b) sofosbuvir with velpatasvir and voxilaprevir for 12 weeks;(c) glecaprevir with pibrentasvir for 8 weeks;(d) glecaprevir with pibrentasvir for 12 weeks;(e) glecaprevir with pibrentasvir for 16 weeks
3	Patient:(a) with Genotype 1; and(b) who is treatment naïve; and(c) who is non-cirrhotic	Either of the following:(a) ledipasvir with sofosbuvir for 8 weeks;(b) ledipasvir with sofosbuvir for 12 weeks
4	Patient:(a) with Genotype 1; and(b) who is treatment experienced; and(c) who is non-cirrhotic	Ledipasvir with sofosbuvir for 12 weeks
5	Patient:(a) with any genotype; and(b) who is treatment naïve; and(c) who is cirrhotic	Any of the following:(a) sofosbuvir with velpatasvir for 12 weeks;(b) glecaprevir with pibrentasvir for 8 weeks;(c) glecaprevir with pibrentasvir for 12 weeks
6	Patient:(a) with any genotype; and(b) who is treatment experienced; and(c) who is cirrhotic	Any of the following:(a) sofosbuvir with velpatasvir for 12 weeks;(b) sofosbuvir with velpatasvir and voxilaprevir for 12 weeks;(c) glecaprevir with pibrentasvir for 12 weeks;(d) glecaprevir with pibrentasvir for 16 weeks
7	Patient:(a) with Genotype 1; and(b) who is treatment naïve; and(c) who is cirrhotic	Ledipasvir with sofosbuvir for 12 weeks
8	Patient:(a) with Genotype 1; and(b) who is treatment experienced; and(c) who is cirrhotic	Ledipasvir with sofosbuvir for 24 weeks

Schedule 1 · Ready-prepared pharmaceutical benefits

Note: See the definition of ready-prepared pharmaceutical benefit in section 5, and sections 6 to 10, 12, 13, 15, 16 and 20 to 23.

Part 1 · Ready-prepared pharmaceutical benefits for prescription and supply

1Matters relating to pharmaceutical benefits#

The following table sets out pharmaceutical benefits and matters relating to pharmaceutical benefits and their prescription and supply, for the purposes of sections 6 to 10, 12, 13, 15, 16 and 20 to 23.

Listed Drug	Form	Manner of Administration	Brand	Responsible Person	Authorised Prescriber	Circumstances	Purposes	Maximum Quantity	Number of Repeats	Variations	Pack Quantity	Section 100/ Prescriber Bag only
Quetiapine	Tablet 25 mg (as fumarate)	Oral	APX-QUETIAPINE	TX	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Blooms The Chemist Quetiapine	BG	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Kaptan	ZS	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Pharmacor Quetiapine 25	CR	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Quetia 25	RW	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Quetiapine RBX	RA	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Quetiapine Sandoz Pharma	HX	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	QUETIAPINE-WGR	WG	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Seroquel	AL	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 25 mg (as fumarate)	Oral	Syquet	AF	MP NP	C4246 C5869 C7927		60	0		60
Quetiapine	Tablet 100 mg (as fumarate)	Oral	APX-QUETIAPINE	TX	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Blooms The Chemist Quetiapine	BG	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Kaptan	ZS	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Pharmacor Quetiapine 100	CR	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Quetia 100	RW	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Quetiapine RBX	RA	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Quetiapine Sandoz Pharma	HX	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	QUETIAPINE-WGR	WG	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Seroquel	AL	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 100 mg (as fumarate)	Oral	Syquet	AF	MP NP	C4246 C5611 C5869		90	5		90
Quetiapine	Tablet 200 mg (as fumarate)	Oral	APX-QUETIAPINE	TX	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Blooms The Chemist Quetiapine	BG	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Kaptan	ZS	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Pharmacor Quetiapine 200	CR	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Quetia 200	RW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Quetiapine RBX	RA	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Quetiapine Sandoz Pharma	HX	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	QUETIAPINE-WGR	WG	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Seroquel	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 200 mg (as fumarate)	Oral	Syquet	AF	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	APX-QUETIAPINE	TX	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Blooms The Chemist Quetiapine	BG	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Kaptan	ZS	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Pharmacor Quetiapine 300	CR	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Quetia 300	RW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Quetiapine RBX	RA	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Quetiapine Sandoz Pharma	HX	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	QUETIAPINE-WGR	WG	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Seroquel	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet 300 mg (as fumarate)	Oral	Syquet	AF	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 50 mg (as fumarate)	Oral	APX-Quetiapine XR	TY	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 50 mg (as fumarate)	Oral	QUETIAPINE-AS XR	RW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 50 mg (as fumarate)	Oral	Quetiapine Sandoz XR	SZ	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 50 mg (as fumarate)	Oral	Quetia XR	OW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 50 mg (as fumarate)	Oral	Seroquel XR	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 50 mg (as fumarate)	Oral	Tevatiapine XR	TB	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 150 mg (as fumarate)	Oral	APX-Quetiapine XR	TY	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 150 mg (as fumarate)	Oral	Quetiapine Sandoz XR	SZ	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 150 mg (as fumarate)	Oral	Quetia XR	OW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 150 mg (as fumarate)	Oral	Seroquel XR	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 150 mg (as fumarate)	Oral	Tevatiapine XR	TB	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 200 mg (as fumarate)	Oral	APX-Quetiapine XR	TY	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 200 mg (as fumarate)	Oral	QUETIAPINE-AS XR	RW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 200 mg (as fumarate)	Oral	Quetiapine Sandoz XR	SZ	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 200 mg (as fumarate)	Oral	Quetia XR	OW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 200 mg (as fumarate)	Oral	Seroquel XR	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 200 mg (as fumarate)	Oral	Tevatiapine XR	TB	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 300 mg (as fumarate)	Oral	APX-Quetiapine XR	TY	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 300 mg (as fumarate)	Oral	QUETIAPINE-AS XR	RW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 300 mg (as fumarate)	Oral	Quetiapine Sandoz XR	SZ	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 300 mg (as fumarate)	Oral	Quetia XR	OW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 300 mg (as fumarate)	Oral	Seroquel XR	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 300 mg (as fumarate)	Oral	Tevatiapine XR	TB	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 400 mg (as fumarate)	Oral	APX-Quetiapine XR	TY	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 400 mg (as fumarate)	Oral	QUETIAPINE-AS XR	RW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 400 mg (as fumarate)	Oral	Quetiapine Sandoz XR	SZ	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 400 mg (as fumarate)	Oral	Quetia XR	OW	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 400 mg (as fumarate)	Oral	Seroquel XR	AL	MP NP	C4246 C5611 C5869		60	5		60
Quetiapine	Tablet (modified release) 400 mg (as fumarate)	Oral	Tevatiapine XR	TB	MP NP	C4246 C5611 C5869		60	5		60
Quinapril	Tablet 5 mg (as hydrochloride)	Oral	ACQUIN	RF	MP NP			30	5		30
Quinapril	Tablet 10 mg (as hydrochloride)	Oral	APO-Quinapril	TX	MP NP			30	5		30
Quinapril	Tablet 20 mg (as hydrochloride)	Oral	APO-Quinapril	TX	MP NP			30	5		30
Quinine	Tablet containing quinine sulfate dihydrate 300 mg	Oral	Quinate	RW	MP NP	C18962		50	2		50
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP NP	C5444 C5512	P5444 P5512	28	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP NP	C15574 C15633	P15574 P15633	56	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	Parbezol	RW	MP NP	C5444 C5512	P5444 P5512	28	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	Parbezol	RW	MP NP	C15574 C15633	P15574 P15633	56	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP NP	C5444 C5512	P5444 P5512	28	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP NP	C15574 C15633	P15574 P15633	56	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	Rabeprazole Viatris	AF	MP NP	C5444 C5512	P5444 P5512	28	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	Rabeprazole Viatris	AF	MP NP	C15574 C15633	P15574 P15633	56	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP NP	C5444 C5512	P5444 P5512	28	5		28
Rabeprazole	Tablet containing rabeprazole sodium 10 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP NP	C15574 C15633	P15574 P15633	56	5		28
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	APO-Rabeprazole	TX	MP	C15856	P15856	120	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Parbezol	RW	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Parbezol	RW	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Parbezol	RW	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Parbezol	RW	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Parbezol	RW	MP	C15856	P15856	120	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Mylan	AF	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Mylan	AF	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Mylan	AF	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Mylan	AF	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Mylan	AF	MP	C15856	P15856	120	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole Sandoz	SZ	MP	C15856	P15856	120	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole SUN	RN	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole SUN	RN	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole SUN	RN	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole SUN	RN	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Rabeprazole SUN	RN	MP	C15856	P15856	120	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	RABEPRAZOLE-WGR	WG	MP	C15856	P15856	120	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Zabep	AL	MP NP	C8774 C8775	P8774 P8775	30	1		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Zabep	AL	MP NP	C8776 C8780	P8776 P8780	30	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Zabep	AL	MP NP	C15530 C15658	P15530 P15658	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Zabep	AL	MP	C11310	P11310	60	5		30
Rabeprazole	Tablet containing rabeprazole sodium 20 mg (enteric coated)	Oral	Zabep	AL	MP	C15856	P15856	120	5		30
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	Evista	BZ	MP NP	C6314	P6314	28	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	Evista	BZ	MP NP	C14274	P14274	56	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	Fixta 60	ZS	MP NP	C6314	P6314	28	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	Fixta 60	ZS	MP NP	C14274	P14274	56	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	RALOVISTA	RF	MP NP	C6314	P6314	28	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	RALOVISTA	RF	MP NP	C14274	P14274	56	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	Raloxifene GH	GQ	MP NP	C6314	P6314	28	5		28
Raloxifene	Tablet containing raloxifene hydrochloride 60 mg	Oral	Raloxifene GH	GQ	MP NP	C14274	P14274	56	5		28
Raltegravir	Tablet 400 mg (as potassium)	Oral	Isentress	MK	MP NP	C4454 C4512		120	5		60	D(100)
Raltegravir	Tablet 600 mg (as potassium)	Oral	Isentress HD	MK	MP NP	C4454 C4512		120	5		60	D(100)
Raltitrexed	Powder for I.V. infusion 2 mg in single use vial	Injection	Tomudex	PF	MP			See Note 3	See Note 3		1	D(100)
Ramipril	Capsule 1.25 mg	Oral	Tryzan Caps 1.25	AF	MP NP			30	5		30
Ramipril	Capsule 1.25 mg	Oral	Tryzan Caps 1.25	AF	MP NP		P14238	60	5		30
Ramipril	Capsule 2.5 mg	Oral	APO-Ramipril	TX	MP NP			30	5		30
Ramipril	Capsule 2.5 mg	Oral	APO-Ramipril	TX	MP NP		P14238	60	5		30
Ramipril	Capsule 2.5 mg	Oral	Tryzan Caps 2.5	AF	MP NP			30	5		30
Ramipril	Capsule 2.5 mg	Oral	Tryzan Caps 2.5	AF	MP NP		P14238	60	5		30
Ramipril	Capsule 5 mg	Oral	APO-Ramipril	TX	MP NP			30	5		30
Ramipril	Capsule 5 mg	Oral	APO-Ramipril	TX	MP NP		P14238	60	5		30
Ramipril	Capsule 5 mg	Oral	Tryzan Caps 5	AF	MP NP			30	5		30
Ramipril	Capsule 5 mg	Oral	Tryzan Caps 5	AF	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	APO-Ramipril	TX	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	APO-Ramipril	TX	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	APX-Ramipril	TY	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	APX-Ramipril	TY	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	Prilace	RF	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	Prilace	RF	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	Ramipril Sandoz	SZ	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	Ramipril Sandoz	SZ	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	RAMIPRIL-WGR	WG	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	RAMIPRIL-WGR	WG	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	Tritace 10 mg	SW	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	Tritace 10 mg	SW	MP NP		P14238	60	5		30
Ramipril	Capsule 10 mg	Oral	Tryzan Caps 10	AF	MP NP			30	5		30
Ramipril	Capsule 10 mg	Oral	Tryzan Caps 10	AF	MP NP		P14238	60	5		30
Ramipril	Tablet 1.25 mg	Oral	Prilace	RF	MP NP			30	5		30
Ramipril	Tablet 1.25 mg	Oral	Prilace	RF	MP NP		P14238	60	5		30
Ramipril	Tablet 1.25 mg	Oral	Ramipril Sandoz	SZ	MP NP			30	5		30
Ramipril	Tablet 1.25 mg	Oral	Ramipril Sandoz	SZ	MP NP		P14238	60	5		30
Ramipril	Tablet 1.25 mg	Oral	Ramipril Viatris	AL	MP NP			30	5		30
Ramipril	Tablet 1.25 mg	Oral	Ramipril Viatris	AL	MP NP		P14238	60	5		30
Ramipril	Tablet 1.25 mg	Oral	RAMIPRIL-WGR	WG	MP NP			30	5		30
Ramipril	Tablet 1.25 mg	Oral	RAMIPRIL-WGR	WG	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	APO-Ramipril	TX	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	APO-Ramipril	TX	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	Prilace	RF	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	Prilace	RF	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	Ramipril Sandoz	SZ	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	Ramipril Sandoz	SZ	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	Ramipril Viatris	AL	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	Ramipril Viatris	AL	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	RAMIPRIL-WGR	WG	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	RAMIPRIL-WGR	WG	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	Ramipril Winthrop	WA	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	Ramipril Winthrop	WA	MP NP		P14238	60	5		30
Ramipril	Tablet 2.5 mg	Oral	Tritace 2.5 mg	SW	MP NP			30	5		30
Ramipril	Tablet 2.5 mg	Oral	Tritace 2.5 mg	SW	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	APO-Ramipril	TX	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	APO-Ramipril	TX	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	Prilace	RF	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	Prilace	RF	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	Ramipril Sandoz	SZ	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	Ramipril Sandoz	SZ	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	Ramipril Viatris	AL	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	Ramipril Viatris	AL	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	RAMIPRIL-WGR	WG	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	RAMIPRIL-WGR	WG	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	Ramipril Winthrop	WA	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	Ramipril Winthrop	WA	MP NP		P14238	60	5		30
Ramipril	Tablet 5 mg	Oral	Tritace 5 mg	SW	MP NP			30	5		30
Ramipril	Tablet 5 mg	Oral	Tritace 5 mg	SW	MP NP		P14238	60	5		30
Ramipril	Tablet 10 mg	Oral	APO-Ramipril	TX	MP NP			30	5		30
Ramipril	Tablet 10 mg	Oral	APO-Ramipril	TX	MP NP		P14238	60	5		30
Ramipril	Tablet 10 mg	Oral	Ramipril Sandoz	SZ	MP NP			30	5		30
Ramipril	Tablet 10 mg	Oral	Ramipril Sandoz	SZ	MP NP		P14238	60	5		30
Ramipril	Tablet 10 mg	Oral	RAMIPRIL TABS-WGR	WG	MP NP			30	5		30
Ramipril	Tablet 10 mg	Oral	RAMIPRIL TABS-WGR	WG	MP NP		P14238	60	5		30
Ramipril	Tablet 10 mg	Oral	Ramipril Viatris	AL	MP NP			30	5		30
Ramipril	Tablet 10 mg	Oral	Ramipril Viatris	AL	MP NP		P14238	60	5		30
Ramipril	Tablet 10 mg	Oral	Tritace	SW	MP NP			30	5		30
Ramipril	Tablet 10 mg	Oral	Tritace	SW	MP NP		P14238	60	5		30
Ramipril with felodipine	Tablet 5 mg-5 mg (modified release)	Oral	Triasyn 5.0/5.0	SW	MP NP			30	5		30
Ramipril with felodipine	Tablet 5 mg-5 mg (modified release)	Oral	Triasyn 5.0/5.0	SW	MP NP		P14238	60	5		30
Ranibizumab	Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe	Injection	Lucentis	NV	MP	C13336 C13340 C13387 C13392 C13406 C15918 C18144 C18145 C18146 C18147	P13336 P13340 P13387 P13392 P13406 P15918 P18144 P18145 P18146 P18147	1	2		1
Ranibizumab	Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe	Injection	Lucentis	NV	MP	C17288 C17395	P17288 P17395	1	5		1
Ranibizumab	Solution for intravitreal injection 2.3 mg in 0.23 mL	Injection	Lucentis	NV	MP	C13336 C13340 C13387 C13392 C13406 C15918 C18144 C18145 C18146 C18147	P13336 P13340 P13387 P13392 P13406 P15918 P18144 P18145 P18146 P18147	1	2		1
Ranibizumab	Solution for intravitreal injection 2.3 mg in 0.23 mL	Injection	Lucentis	NV	MP	C17288 C17395	P17288 P17395	1	5		1
Ranitidine	Tablet 150 mg (as hydrochloride)	Oral	APO-Ranitidine	TX	MP NP MW			60	5		60
Ranitidine	Tablet 150 mg (as hydrochloride)	Oral	Zantac 150	AS	MP MW NP			60	5		60
Ranitidine	Tablet 300 mg (as hydrochloride)	Oral	APO-Ranitidine	TX	MP NP			30	5		30
Ranitidine	Tablet 300 mg (as hydrochloride)	Oral	Zantac 300	AS	MP MW NP			30	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Alziras	RW	MP NP	C5339	P5339	30	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Alziras	RW	MP NP	C15648	P15648	60	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Azilect	TB	MP NP	C5339	P5339	30	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Azilect	TB	MP NP	C15648	P15648	60	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Pharmacor Rasagiline	CR	MP NP	C5339	P5339	30	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Pharmacor Rasagiline	CR	MP NP	C15648	P15648	60	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Rasagiline Lupin	HQ	MP NP	C5339	P5339	30	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Rasagiline Lupin	HQ	MP NP	C15648	P15648	60	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Rasagiline-Teva	EV	MP NP	C5339	P5339	30	5		30
Rasagiline	Tablet 1 mg (as mesilate)	Oral	Rasagiline-Teva	EV	MP NP	C15648	P15648	60	5		30
Ravulizumab	Solution concentrate for I.V. infusion 1,100 mg in 11 mL	Injection	Ultomiris	XI	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Ravulizumab	Solution concentrate for I.V. infusion 300 mg in 3 mL	Injection	Ultomiris	XI	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Reboxetine	Tablet 4 mg (as mesilate)	Oral	Edronax	PF	MP NP	C5650	C5650	60	5		60
Reboxetine	Tablet 4 mg (as mesilate)	Oral	Edronax	PF	MP NP	C15553	P15553	120	2		60
Relugolix with estradiol and with norethisterone	Tablet containing relugolix 40 mg with estradiol (as hemihydrate) 1 mg and with norethisterone acetate 500 micrograms	Oral	Ryeqo	FX	MP	C16429 C16430		28	5		28
Repotrectinib	Capsule 40 mg	Oral	Augtyro	BQ	MP	C13186 C18244		120	3		120
Repotrectinib	Capsule 160 mg	Oral	Augtyro	BQ	MP	C13186 C18244		60	3		60
Ribociclib	Tablet 200 mg	Oral	Kisqali	NV	MP NP	C17853 C18033 C19283	P17853 P18033 P19283	21	5		21
Ribociclib	Tablet 200 mg	Oral	Kisqali	NV	MP NP	C17940 C17977 C19280	P17940 P17977 P19280	42	5		42
Ribociclib	Tablet 200 mg	Oral	Kisqali	NV	MP NP	C17774 C17847	P17774 P17847	63	5		63
Rifabutin	Capsule 150 mg	Oral	Mycobutin	PF	MP NP	C6350 C6356 C9560 C9622		120	5		30	D(100)
Rifampicin	Capsule 150 mg	Oral	Rimycin 150	AF	MP NP	C16037 C16075	P16037 P16075	10	0		10
Rifampicin	Capsule 150 mg	Oral	Rimycin 150	AF	MP NP	C15973 C16043	P15973 P16043	100	0		100
Rifampicin	Capsule 150 mg	Oral	Rimycin 150	AF	MP NP	C16043	P16043	120	0		10
Rifampicin	Capsule 300 mg	Oral	Rimycin 300	AF	MP NP	C16037 C16075	P16037 P16075	10	0		10
Rifampicin	Capsule 300 mg	Oral	Rimycin 300	AF	MP NP	C15973 C16043	P15973 P16043	100	0		100
Rifampicin	Capsule 300 mg	Oral	Rimycin 300	AF	MP NP	C16043	P16043	120	0		10
Rifampicin	Syrup 100 mg per 5 mL, 60 mL	Oral	Rifadin	SW	MP NP	C16037 C16075		1	0		1
Rifaximin	Tablet 550 mg	Oral	Xifaxan	NE	MP NP	C4306		56	5		56
Rilpivirine	Tablet 25 mg (as hydrochloride)	Oral	Edurant	JC	MP NP	C4454 C4512		60	5		30	D(100)
Riluzole	Oral suspension 50 mg per 10 mL, 300 mL	Oral	Teglutik	JW	MP NP	C5341 C8738	C5341 C8738	2	5		1
Riluzole	Oral suspension 50 mg per 10 mL, 300 mL	Oral	Teglutik	JW	MP NP	C15719	P15719	4	5		1
Riluzole	Tablet 50 mg	Oral	Pharmacor Riluzole	CR	MP NP	C5341 C8738	C5341 C8738	56	5		56
Riluzole	Tablet 50 mg	Oral	Pharmacor Riluzole	CR	MP NP	C15719	P15719	112	5		56
Riluzole	Tablet 50 mg	Oral	Rilutek	SW	MP NP	C5341 C8738	C5341 C8738	56	5		56
Riluzole	Tablet 50 mg	Oral	Rilutek	SW	MP NP	C15719	P15719	112	5		56
Riluzole	Tablet 50 mg	Oral	Riluzole Sandoz	SZ	MP NP	C5341 C8738	C5341 C8738	56	5		56
Riluzole	Tablet 50 mg	Oral	Riluzole Sandoz	SZ	MP NP	C15719	P15719	112	5		56
Riociguat	Tablet 500 micrograms	Oral	Adempas	BN	MP	See Note 3	See Note 3	See Note 3	See Note 3		42	D(100)
Riociguat	Tablet 1 mg	Oral	Adempas	BN	MP	See Note 3	See Note 3	See Note 3	See Note 3		42	D(100)
Riociguat	Tablet 1.5 mg	Oral	Adempas	BN	MP	See Note 3	See Note 3	See Note 3	See Note 3		42	D(100)
Riociguat	Tablet 2 mg	Oral	Adempas	BN	MP	See Note 3	See Note 3	See Note 3	See Note 3		42	D(100)
Riociguat	Tablet 2.5 mg	Oral	Adempas	BN	MP	See Note 3	See Note 3	See Note 3	See Note 3		42	D(100)
Ripretinib	Tablet 50 mg	Oral	Qinlock	ZB	MP	C12440 C12455		90	1		90
Risankizumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Skyrizi	VE	MP	C15902 C15903 C18530 C18571 C18583	P15902 P15903 P18530 P18571 P18583	1	1		1
Risankizumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Skyrizi	VE	MP	C16338 C16339 C16340 C16391 C18575 C18576 C18610 C18646 C18664 C18677 C18715	P16338 P16339 P16340 P16391 P18575 P18576 P18610 P18646 P18664 P18677 P18715	1	2		1
Risdiplam	Powder for oral solution 750 micrograms per mL, 80 mL	Oral	Evrysdi	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Risdiplam	Tablet 5 mg	Oral	Evrysdi	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3		28	D(100)
Risedronic acid	Tablet (enteric coated) containing risedronate sodium 35 mg	Oral	Actonel EC	TT	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	4	5		4
Risedronic acid	Tablet (enteric coated) containing risedronate sodium 35 mg	Oral	Actonel EC	TT	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	8	5		4
Risedronic acid	Tablet containing risedronate sodium 5 mg	Oral	Actonel	TT	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	28	5		28
Risedronic acid	Tablet containing risedronate sodium 5 mg	Oral	Actonel	TT	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	56	5		28
Risedronic acid	Tablet containing risedronate sodium 30 mg	Oral	Actonel	TT	MP NP	C16577		28	1		28
Risedronic acid	Tablet containing risedronate sodium 35 mg	Oral	APO-Risedronate	TX	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	4	5		4
Risedronic acid	Tablet containing risedronate sodium 35 mg	Oral	APO-Risedronate	TX	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	8	5		4
Risedronic acid	Tablet containing risedronate sodium 35 mg	Oral	Risedronate Sandoz	SZ	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	4	5		4
Risedronic acid	Tablet containing risedronate sodium 35 mg	Oral	Risedronate Sandoz	SZ	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	8	5		4
Risedronic acid	Tablet containing risedronate sodium 35 mg	Oral	RISEDRONATE-WGR	WG	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	4	5		4
Risedronic acid	Tablet containing risedronate sodium 35 mg	Oral	RISEDRONATE-WGR	WG	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	8	5		4
Risedronic acid	Tablet containing risedronate sodium 150 mg	Oral	Actonel Once-a-Month	TT	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	1	5		1
Risedronic acid	Tablet containing risedronate sodium 150 mg	Oral	Actonel Once-a-Month	TT	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	2	5		1
Risedronic acid	Tablet containing risedronate sodium 150 mg	Oral	APO-Risedronate	TX	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	1	5		1
Risedronic acid	Tablet containing risedronate sodium 150 mg	Oral	APO-Risedronate	TX	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	2	5		1
Risedronic acid	Tablet containing risedronate sodium 150 mg	Oral	Risedronate Way	IX	MP NP	C6310 C6323 C6327	P6310 P6323 P6327	1	5		1
Risedronic acid	Tablet containing risedronate sodium 150 mg	Oral	Risedronate Way	IX	MP NP	C14234 C14235 C14263	P14234 P14235 P14263	2	5		1
Risperidone	I.M. injection (modified release), set containing 1 pre-filled syringe powder for injection 75 mg and 1 pre-filled syringe diluent 383 microlitres	Injection	Risvan	SE	MP NP	C16231		1	5		1
Risperidone	I.M. injection (modified release), set containing 1 pre-filled syringe powder for injection 100 mg and 1 pre-filled syringe diluent 490 microlitres	Injection	Risvan	SE	MP NP	C16231		1	5		1
Risperidone	I.M. injection (modified release), set containing 1 vial powder for injection 25 mg and 1 pre-filled syringe diluent 2 mL	Injection	Risperdal Consta	JC	MP NP	C4246 C5912		2	5		1
Risperidone	I.M. injection (modified release), set containing 1 vial powder for injection 37.5 mg and 1 pre-filled syringe diluent 2 mL	Injection	Risperdal Consta	JC	MP NP	C4246 C5912		2	5		1
Risperidone	I.M. injection (modified release), set containing 1 vial powder for injection 50 mg and 1 pre-filled syringe diluent 2 mL	Injection	Risperdal Consta	JC	MP NP	C4246 C5912		2	5		1
Risperidone	Oral solution 1 mg per mL, 100 mL	Oral	Risperdal	JC	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	1	2		1
Risperidone	Oral solution 1 mg per mL, 100 mL	Oral	Risperdal	JC	MP NP	C4246 C5907	P4246 P5907	1	5		1
Risperidone	Oral solution 1 mg per mL, 100 mL	Oral	Risperidone Lupin	GQ	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	1	2		1
Risperidone	Oral solution 1 mg per mL, 100 mL	Oral	Risperidone Lupin	GQ	MP NP	C4246 C5907	P4246 P5907	1	5		1
Risperidone	Oral solution 1 mg per mL, 100 mL	Oral	Rixadone	AF	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	1	2		1
Risperidone	Oral solution 1 mg per mL, 100 mL	Oral	Rixadone	AF	MP NP	C4246 C5907	P4246 P5907	1	5		1
Risperidone	Tablet 0.5 mg	Oral	APO-Risperidone	TX	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 0.5 mg	Oral	APO-Risperidone	TX	MP NP	C4246	P4246	60	5		60
Risperidone	Tablet 0.5 mg	Oral	Ozidal	RA	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 0.5 mg	Oral	Ozidal	RA	MP NP	C4246	P4246	60	5		60
Risperidone	Tablet 0.5 mg	Oral	Rispa	RW	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 0.5 mg	Oral	Rispa	RW	MP NP	C4246	P4246	60	5		60
Risperidone	Tablet 0.5 mg	Oral	Risperidone Sandoz	SZ	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 0.5 mg	Oral	Risperidone Sandoz	SZ	MP NP	C4246	P4246	60	5		60
Risperidone	Tablet 0.5 mg	Oral	Rispernia	ZS	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 0.5 mg	Oral	Rispernia	ZS	MP NP	C4246	P4246	60	5		60
Risperidone	Tablet 0.5 mg	Oral	Rixadone	AF	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 0.5 mg	Oral	Rixadone	AF	MP NP	C4246	P4246	60	5		60
Risperidone	Tablet 1 mg	Oral	APO-Risperidone	TX	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 1 mg	Oral	APO-Risperidone	TX	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 1 mg	Oral	Ozidal	RA	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 1 mg	Oral	Ozidal	RA	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 1 mg	Oral	Rispa	RW	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 1 mg	Oral	Rispa	RW	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 1 mg	Oral	Risperidone Sandoz	SZ	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 1 mg	Oral	Risperidone Sandoz	SZ	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 1 mg	Oral	Rispernia	ZS	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 1 mg	Oral	Rispernia	ZS	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 1 mg	Oral	Rixadone	AF	MP NP	C6898 C10020 C10021 C16048	P6898 P10020 P10021 P16048	60	2		60
Risperidone	Tablet 1 mg	Oral	Rixadone	AF	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 2 mg	Oral	APO-Risperidone	TX	MP NP	C6898 C16048	P6898 P16048	60	2		60
Risperidone	Tablet 2 mg	Oral	APO-Risperidone	TX	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 2 mg	Oral	Ozidal	RA	MP NP	C6898 C16048	P6898 P16048	60	2		60
Risperidone	Tablet 2 mg	Oral	Ozidal	RA	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 2 mg	Oral	Rispa	RW	MP NP	C6898 C16048	P6898 P16048	60	2		60
Risperidone	Tablet 2 mg	Oral	Rispa	RW	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 2 mg	Oral	Risperidone Sandoz	SZ	MP NP	C6898 C16048	P6898 P16048	60	2		60
Risperidone	Tablet 2 mg	Oral	Risperidone Sandoz	SZ	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 2 mg	Oral	Rispernia	ZS	MP NP	C6898 C16048	P6898 P16048	60	2		60
Risperidone	Tablet 2 mg	Oral	Rispernia	ZS	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 2 mg	Oral	Rixadone	AF	MP NP	C6898 C16048	P6898 P16048	60	2		60
Risperidone	Tablet 2 mg	Oral	Rixadone	AF	MP NP	C4246 C5907	P4246 P5907	60	5		60
Risperidone	Tablet 3 mg	Oral	APO-Risperidone	TX	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 3 mg	Oral	Ozidal	RA	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 3 mg	Oral	Rispa	RW	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 3 mg	Oral	Risperidone Sandoz	SZ	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 3 mg	Oral	Rispernia	ZS	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 3 mg	Oral	Rixadone	AF	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 4 mg	Oral	APO-Risperidone	TX	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 4 mg	Oral	Rispa	RW	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 4 mg	Oral	Risperidone Sandoz	SZ	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 4 mg	Oral	Rispernia	ZS	MP NP	C4246 C5907		60	5		60
Risperidone	Tablet 4 mg	Oral	Rixadone	AF	MP NP	C4246 C5907		60	5		60
Ritonavir	Tablet 100 mg	Oral	Norvir	VE	MP NP	C4454 C4512		720	5		30	D(100)
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Riximyo	SZ	MP			6	0		2	D(100)
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Riximyo	SZ	MP			See Note 3	See Note 3		2	D(100)
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Ruxience	PF	MP			6	0		1	D(100)
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Ruxience	PF	MP			See Note 3	See Note 3		1	D(100)
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Truxima	EW	MP			6	0		2	D(100)
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Truxima	EW	MP			See Note 3	See Note 3		2	D(100)
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Riximyo	SZ	MP			2	1		1	D(100)
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Riximyo	SZ	MP			See Note 3	See Note 3		1	D(100)
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Ruxience	PF	MP			2	1		1	D(100)
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Ruxience	PF	MP			See Note 3	See Note 3		1	D(100)
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Truxima	EW	MP			2	1		1	D(100)
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Truxima	EW	MP			See Note 3	See Note 3		1	D(100)
Rivaroxaban	Capsule 15 mg	Oral	Relaban	NB	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Capsule 15 mg	Oral	Relaban	NB	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Capsule 20 mg	Oral	Relaban	NB	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Capsule 20 mg	Oral	Relaban	NB	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 2.5 mg	Oral	APO-Rivaroxaban	TX	MP NP	C10992	P10992	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	APO-Rivaroxaban	TX	MP	C11013	P11013	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	APO-Rivaroxaban	TX	MP NP	C14298	P14298	120	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C10992	P10992	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Rivaroxaban Lupin	GQ	MP	C11013	P11013	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C14298	P14298	120	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C10992	P10992	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Rivaroxaban-Teva	TB	MP	C11013	P11013	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C14298	P14298	120	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	RIVOXA	CR	MP NP	C10992	P10992	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	RIVOXA	CR	MP	C11013	P11013	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	RIVOXA	CR	MP NP	C14298	P14298	120	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Xarelto	AF	MP NP	C10992	P10992	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Xarelto	AF	MP	C11013	P11013	60	5		60
Rivaroxaban	Tablet 2.5 mg	Oral	Xarelto	AF	MP NP	C14298	P14298	120	5		60
Rivaroxaban	Tablet 10 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4382	P4382	15	0		15
Rivaroxaban	Tablet 10 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4402	P4402	15	1		15
Rivaroxaban	Tablet 10 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	APO-Rivaroxaban	TX	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	ARX-Rivaroxaban 10	XT	MP NP	C4382	P4382	15	0		15
Rivaroxaban	Tablet 10 mg	Oral	ARX-Rivaroxaban 10	XT	MP NP	C4402	P4402	15	1		15
Rivaroxaban	Tablet 10 mg	Oral	ARX-Rivaroxaban 10	XT	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	ARX-Rivaroxaban 10	XT	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	ARX-Rivaroxaban 10	XT	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	iXarola	AL	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	iXarola	AL	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	iXarola	AL	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivarelto	XW	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Rivarelto	XW	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivarelto	XW	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	RIVAXIB	MQ	MP NP	C4382	P4382	15	0		15
Rivaroxaban	Tablet 10 mg	Oral	RIVAXIB	MQ	MP NP	C4402	P4402	15	1		15
Rivaroxaban	Tablet 10 mg	Oral	RIVAXIB	MQ	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	RIVAXIB	MQ	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	RIVAXIB	MQ	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivoxa	CR	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Rivoxa	CR	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Rivoxa	CR	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	TROXA	XG	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	TROXA	XG	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	TROXA	XG	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	Xarelto	AF	MP NP	C4382	P4382	15	0		15
Rivaroxaban	Tablet 10 mg	Oral	Xarelto	AF	MP NP	C4402	P4402	15	1		15
Rivaroxaban	Tablet 10 mg	Oral	Xarelto	AF	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	Xarelto	AF	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	Xarelto	AF	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 10 mg	Oral	XAREMED	DZ	MP NP	C4382	P4382	15	0		15
Rivaroxaban	Tablet 10 mg	Oral	XAREMED	DZ	MP NP	C4402	P4402	15	1		15
Rivaroxaban	Tablet 10 mg	Oral	XAREMED	DZ	MP NP	C4402	P4402	30	0		30
Rivaroxaban	Tablet 10 mg	Oral	XAREMED	DZ	MP NP	C4132	P4132	30	5		30
Rivaroxaban	Tablet 10 mg	Oral	XAREMED	DZ	MP NP	C14300	P14300	60	5		30
Rivaroxaban	Tablet 15 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	APO-Rivaroxaban	TX	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	ARX-Rivaroxaban 15	XT	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	ARX-Rivaroxaban 15	XT	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	ARX-Rivaroxaban 15	XT	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	iXarola	AL	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	iXarola	AL	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivarelto	XW	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivarelto	XW	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	Rivarelto	XW	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	RIVAXIB	MQ	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	RIVAXIB	MQ	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	RIVAXIB	MQ	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivoxa	CR	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Rivoxa	CR	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	Rivoxa	CR	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	TROXA	XG	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	TROXA	XG	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	Xarelto	AF	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	Xarelto	AF	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	Xarelto	AF	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 15 mg	Oral	XAREMED	DZ	MP NP	C4269	P4269	28	5		28
Rivaroxaban	Tablet 15 mg	Oral	XAREMED	DZ	MP NP	C4098 C5098	P4098 P5098	42	0		42
Rivaroxaban	Tablet 15 mg	Oral	XAREMED	DZ	MP NP	C14301	P14301	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	APO-Rivaroxaban	TX	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	APO-Rivaroxaban	TX	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	ARX-Rivaroxaban 20	XT	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	ARX-Rivaroxaban 20	XT	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	iXarola	AL	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	iXarola	AL	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivarelto	XW	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivarelto	XW	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban Dr.Reddy's	RZ	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban Lupin	GQ	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban Sandoz	SZ	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivaroxaban-Teva	TB	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	RIVAXIB	MQ	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	RIVAXIB	MQ	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivoxa	CR	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Rivoxa	CR	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	TROXA	XG	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	TROXA	XG	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	Xarelto	AF	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	Xarelto	AF	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivaroxaban	Tablet 20 mg	Oral	XAREMED	DZ	MP NP	C4099 C4132 C4268 C4269	P4099 P4132 P4268 P4269	28	5		28
Rivaroxaban	Tablet 20 mg	Oral	XAREMED	DZ	MP NP	C14264 C14300 C14301 C14318	P14264 P14300 P14301 P14318	56	5		28
Rivastigmine	Capsule 1.5 mg (as hydrogen tartrate)	Oral	Exelon	NV	MP NP	C13938 C13940 C13941		56	5		56
Rivastigmine	Capsule 3 mg (as hydrogen tartrate)	Oral	Exelon	NV	MP NP	C13938 C13940 C13941		56	5		56
Rivastigmine	Capsule 4.5 mg (as hydrogen tartrate)	Oral	Exelon	NV	MP NP	C13938 C13940 C13941		56	5		56
Rivastigmine	Capsule 6 mg (as hydrogen tartrate)	Oral	Exelon	NV	MP NP	C13938 C13940 C13941		56	5		56
Rivastigmine	Transdermal patch 9 mg	Transdermal	Exelon Patch 5	NV	MP NP	C13938 C13940 C13941		30	5		30
Rivastigmine	Transdermal patch 18 mg	Transdermal	Exelon Patch 10	NV	MP NP	C13938 C13940 C13941		30	5		30
Rivastigmine	Transdermal patch 27 mg	Transdermal	Exelon Patch 15	NV	MP NP	C13938 C13940 C13941		30	5		30
Rizatriptan	Tablet (orally disintegrating) 10 mg (as benzoate)	Oral	APO-RIZATRIPTAN ODT	TW	MP NP	C5141		4	5		2
Rizatriptan	Tablet (orally disintegrating) 10 mg (as benzoate)	Oral	RIXALT	RF	MP NP	C5141		4	5		2
Rizatriptan	Tablet (orally disintegrating) 10 mg (as benzoate)	Oral	Rizatriptan-Au	DZ	MP NP	C5141		4	5		2
Rizatriptan	Tablet (orally disintegrating) 10 mg (as benzoate)	Oral	Rizatriptan ODT Viatris	MQ	MP NP	C5141		4	5		2
Rizatriptan	Tablet (orally disintegrating) 10 mg (as benzoate)	Oral	RIZATRIPTAN ODT-WGR	WG	MP NP	C5141		4	5		2
Rizatriptan	Wafer 10 mg (as benzoate)	Oral	Maxalt	AL	MP NP	C5141		4	5		2
Rizatriptan	Wafer 10 mg (as benzoate)	Oral	Rizatriptan Wafers-10mg	AF	MP NP	C5141		4	5		2
Romidepsin	Powder for injection 10 mg with solvent	Injection	ROMIDEPSIN-REACH	RQ	MP	C18736 C18800 C18832		See Note 3	See Note 3		1	D(100)
Romiplostim	Powder for injection 375 micrograms	Injection	Nplate	AN	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Romiplostim	Powder for injection 625 micrograms	Injection	Nplate	AN	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Romosozumab	Injection 105 mg in 1.17 mL single use pre-filled syringe	Injection	Evenity	AN	MP	C16022 C16023 C18927 C18972		2	5		2
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Cavstat	AF	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Cavstat	AF	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Crestor	FK	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Crestor	FK	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Crosuva 5	RW	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Crosuva 5	RW	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Pharmacor Rosuvastatin 5	CR	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Pharmacor Rosuvastatin 5	CR	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP			30	5		30
Rosuvastatin	Tablet 5 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Cavstat	AF	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Cavstat	AF	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Crestor	FK	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Crestor	FK	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Crosuva 10	RW	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Crosuva 10	RW	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Pharmacor Rosuvastatin 10	CR	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Pharmacor Rosuvastatin 10	CR	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP			30	5		30
Rosuvastatin	Tablet 10 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Cavstat	AF	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Cavstat	AF	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Crestor	FK	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Crestor	FK	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Crosuva 20	RW	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Crosuva 20	RW	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Pharmacor Rosuvastatin 20	CR	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Pharmacor Rosuvastatin 20	CR	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP			30	5		30
Rosuvastatin	Tablet 20 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	APO-ROSUVASTATIN	TX	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	APX-Rosuvastatin	TY	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Blooms Rosuvastatin	BG	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Cavstat	AF	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Cavstat	AF	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Crestor	FK	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Crestor	FK	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Crosuva 40	RW	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Crosuva 40	RW	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Pharmacor Rosuvastatin 40	CR	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Pharmacor Rosuvastatin 40	CR	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Rosuvastatin Lupin	GQ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Rosuvastatin RBX	RA	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	Rosuvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP			30	5		30
Rosuvastatin	Tablet 40 mg (as calcium)	Oral	ROSUVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Rotigotine	Transdermal patch 4.5 mg	Transdermal	Neupro	UC	MP NP	C17323	P17323	28	5		28
Rotigotine	Transdermal patch 4.5 mg	Transdermal	Neupro	UC	MP NP	C17278	P17278	56	5		28
Rotigotine	Transdermal patch 9 mg	Transdermal	Neupro	UC	MP NP	C17323	P17323	28	5		28
Rotigotine	Transdermal patch 9 mg	Transdermal	Neupro	UC	MP NP	C17278	P17278	56	5		28
Rotigotine	Transdermal patch 13.5 mg	Transdermal	Neupro	UC	MP NP	C17323	P17323	28	5		28
Rotigotine	Transdermal patch 13.5 mg	Transdermal	Neupro	UC	MP NP	C17278	P17278	56	5		28
Rotigotine	Transdermal patch 18 mg	Transdermal	Neupro	UC	MP NP	C17323	P17323	28	5		28
Rotigotine	Transdermal patch 18 mg	Transdermal	Neupro	UC	MP NP	C17278	P17278	56	5		28
Roxithromycin	Tablet 150 mg	Oral	APX-Roxithromycin	TY	MP NP PDP			10	0		10
Roxithromycin	Tablet 150 mg	Oral	APX-Roxithromycin	TY	MP NP		P10404	20CN10404	0CN10404		10
Roxithromycin	Tablet 150 mg	Oral	Roxar 150	RW	MP NP PDP			10	0		10
Roxithromycin	Tablet 150 mg	Oral	Roxar 150	RW	MP NP		P10404	20CN10404	0CN10404		10
Roxithromycin	Tablet 150 mg	Oral	Roxithromycin Sandoz	SZ	MP NP PDP			10	0		10
Roxithromycin	Tablet 150 mg	Oral	Roxithromycin Sandoz	SZ	MP NP		P10404	20CN10404	0CN10404		10
Roxithromycin	Tablet 150 mg	Oral	ROXITHROMYCIN-WGR	WG	MP NP PDP			10	0		10
Roxithromycin	Tablet 150 mg	Oral	ROXITHROMYCIN-WGR	WG	MP NP		P10404	20 CN10404	0 CN10404		10
Roxithromycin	Tablet 300 mg	Oral	APX-Roxithromycin	TY	MP NP PDP			5	0		5
Roxithromycin	Tablet 300 mg	Oral	APX-Roxithromycin	TY	MP NP		P10404	10CN10404	0CN10404		5
Roxithromycin	Tablet 300 mg	Oral	Roxar 300	RW	MP NP PDP			5	0		5
Roxithromycin	Tablet 300 mg	Oral	Roxar 300	RW	MP NP		P10404	10CN10404	0CN10404		5
Roxithromycin	Tablet 300 mg	Oral	Roxithromycin Sandoz	SZ	MP NP PDP			5	0		5
Roxithromycin	Tablet 300 mg	Oral	Roxithromycin Sandoz	SZ	MP NP		P10404	10CN10404	0CN10404		5
Roxithromycin	Tablet 300 mg	Oral	ROXITHROMYCIN-WGR	WG	MP NP PDP			5	0		5
Roxithromycin	Tablet 300 mg	Oral	ROXITHROMYCIN-WGR	WG	MP NP		P10404	10 CN10404	0 CN10404		5
Rozanolixizumab	Solution for subcutaneous infusion 280 mg in 2 mL (140 mg per mL)	Injection	Rystiggo	UC	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NV	MP	C13907 C13911	P13907 P13911	56	0		56	C(100)
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NV	MP NP	C13906 C19100 C19103 C19104 C19146 C19191	P13906 P19100 P19103 P19104 P19146 P19191	56	5		56
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NV	MP NP	C19098 C19147	P19098 P19147	56	5		56	C(100)
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NV	MP NP	C18241 C18324	P18241 P18324	112	5		56
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NV	MP	C16364 C16365	P16364 P16365	112	5		56
Ruxolitinib	Tablet 10 mg	Oral	Jakavi	NV	MP	C13907 C13911	P13907 P13911	56	0		56	C(100)
Ruxolitinib	Tablet 10 mg	Oral	Jakavi	NV	MP NP	C13906 C18241 C18324 C19100 C19103 C19104 C19146 C19191	P13906 P18241 P18324 P19100 P19103 P19104 P19146 P19191	56	5		56
Ruxolitinib	Tablet 10 mg	Oral	Jakavi	NV	MP NP	C19098 C19147	P19098 P19147	56	5		56	C(100)
Ruxolitinib	Tablet 10 mg	Oral	Jakavi	NV	MP	C16364 C16365	P16364 P16365	56	5		56
Ruxolitinib	Tablet 15 mg	Oral	Jakavi	NV	MP NP	C18241 C18324 C19100 C19103 C19104 C19146		56	5		56
Ruxolitinib	Tablet 15 mg	Oral	Jakavi	NV	MP	C16364 C16365		56	5		56
Ruxolitinib	Tablet 20 mg	Oral	Jakavi	NV	MP NP	C18241 C18324 C19100 C19103 C19104 C19146		56	5		56
Ruxolitinib	Tablet 20 mg	Oral	Jakavi	NV	MP	C16364 C16365		56	5		56
Sacituzumab govitecan	Powder for injection 180 mg	Injection	Trodelvy	GI	MP	C12656 C12669		See Note 3	See Note 3		1	D(100)
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Entresto	NV	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Entresto	NV	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Omtralo	NM	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Omtralo	NM	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Pharmacor Sacubitril/Valsartan	CR	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Pharmacor Sacubitril/Valsartan	CR	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Sacubitril/Valsartan Alphapharm	FY	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Sacubitril/Valsartan Alphapharm	FY	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Sacubitril/Valsartan Lupin 24/26	GQ	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Sacubitril/Valsartan Lupin 24/26	GQ	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	SACUBITRIL/VALSARTAN-WGR	WG	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	SACUBITRIL/VALSARTAN-WGR	WG	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Valtresto	TX	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 24.3 mg with valsartan 25.7 mg	Oral	Valtresto	TX	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Entresto	NV	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Entresto	NV	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Omtralo	NM	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Omtralo	NM	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Pharmacor Sacubitril/Valsartan	CR	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Pharmacor Sacubitril/Valsartan	CR	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Sacubitril/Valsartan Alphapharm	FY	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Sacubitril/Valsartan Alphapharm	FY	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Sacubitril/Valsartan Lupin 49/51	GQ	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Sacubitril/Valsartan Lupin 49/51	GQ	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	SACUBITRIL/VALSARTAN-WGR	WG	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	SACUBITRIL/VALSARTAN-WGR	WG	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Valtresto	TX	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 48.6 mg with valsartan 51.4 mg	Oral	Valtresto	TX	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Entresto	NV	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Entresto	NV	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Omtralo	NM	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Omtralo	NM	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Pharmacor Sacubitril/Valsartan	CR	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Pharmacor Sacubitril/Valsartan	CR	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Sacubitril/Valsartan Alphapharm	FY	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Sacubitril/Valsartan Alphapharm	FY	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Sacubitril/Valsartan Lupin 97/103	GQ	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Sacubitril/Valsartan Lupin 97/103	GQ	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	SACUBITRIL/VALSARTAN-WGR	WG	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	SACUBITRIL/VALSARTAN-WGR	WG	MP NP	C18338	P18338	112	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Valtresto	TX	MP NP	C18150	P18150	56	5		56
Sacubitril with valsartan	Tablet containing sacubitril 97.2 mg with valsartan 102.8 mg	Oral	Valtresto	TX	MP NP	C18338	P18338	112	5		56
Safinamide	Tablet 50 mg	Oral	ARX-Safinamide	XT	MP NP	C8624	P8624	30	5		30
Safinamide	Tablet 50 mg	Oral	ARX-Safinamide	XT	MP NP	C15699	P15699	60	5		30
Safinamide	Tablet 50 mg	Oral	Xadago	IX	MP NP	C8624	P8624	30	5		30
Safinamide	Tablet 50 mg	Oral	Xadago	IX	MP NP	C15699	P15699	60	5		30
Safinamide	Tablet 50 mg	Oral	XAFIMED	DZ	MP NP	C8624	P8624	30	5		30
Safinamide	Tablet 50 mg	Oral	XAFIMED	DZ	MP NP	C15699	P15699	60	5		30
Safinamide	Tablet 100 mg	Oral	ARX-Safinamide	XT	MP NP	C8624	P8624	30	5		30
Safinamide	Tablet 100 mg	Oral	ARX-Safinamide	XT	MP NP	C15699	P15699	60	5		30
Safinamide	Tablet 100 mg	Oral	Xadago	IX	MP NP	C8624	P8624	30	5		30
Safinamide	Tablet 100 mg	Oral	Xadago	IX	MP NP	C15699	P15699	60	5		30
Safinamide	Tablet 100 mg	Oral	XAFIMED	DZ	MP NP	C8624	P8624	30	5		30
Safinamide	Tablet 100 mg	Oral	XAFIMED	DZ	MP NP	C15699	P15699	60	5		30
Salbutamol	Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20	Inhalation	Ventolin Nebules	GK	MP NP	C6815 C6825		3	5		1
Salbutamol	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20	Inhalation	Ventolin Nebules	GK	MP NP	C6815 C6825		3	5		1
Salbutamol	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 20 (s19A)	Inhalation	Salbutamol (as sulfate) (Accord, UK)	OJ	MP NP	C6815 C6825		3	5		1
Salbutamol	Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30	Inhalation	Salbutamol Cipla	LR	MP NP	C6815 C6825		2	5		1
Salbutamol	Oral solution 2 mg (as sulfate) per 5 mL, 150 mL	Oral	Ventolin	GK	MP NP			2	5		1
Salbutamol	Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)	Inhalation by mouth	Asmol CFC-Free with dose counter	AF	MP NP			2	5		1
Salbutamol	Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)	Inhalation by mouth	Ventolin CFC-Free with dose counter	GK	MP NP			2	5		1
Salbutamol	Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)	Inhalation by mouth	Zempreon CFC-Free with dose counter	AL	MP NP			2	5		1
Salbutamol	Pressurised inhalation in breath actuated device 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	Airomir Autohaler	IL	MP NP	C6367		2	5		1
Salmeterol	Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses	Inhalation by mouth	Serevent Accuhaler	GK	MP NP	C6355	P6355	1	5		1
Salmeterol	Powder for oral inhalation in breath actuated device 50 micrograms (as xinafoate) per dose, 60 doses	Inhalation by mouth	Serevent Accuhaler	GK	MP NP	C15607	P15607	2	5		1
Sapropterin	Powder for oral solution 500 mg (as dihydrochloride)	Oral	Kuvan	IO	MP	C10391 C13868 C13885	P10391 P13868 P13885	30	0		30
Sapropterin	Powder for oral solution 500 mg (as dihydrochloride)	Oral	Kuvan	IO	MP NP	C10355 C13880 C13912	P10355 P13880 P13912	30	5		30
Sapropterin	Tablet (soluble) containing sapropterin dihydrochloride 100 mg	Oral	Kuvan	IO	MP	C13868 C13885	P13868 P13885	30	0		30
Sapropterin	Tablet (soluble) containing sapropterin dihydrochloride 100 mg	Oral	Kuvan	IO	MP NP	C11836 C11960	P11836 P11960	30	5		30
Sapropterin	Tablet (soluble) containing sapropterin dihydrochloride 100 mg	Oral	Kuvan	IO	MP	C10076	P10076	180	0		30
Sapropterin	Tablet (soluble) containing sapropterin dihydrochloride 100 mg	Oral	Kuvan	IO	MP NP	C10390 C13880 C13912	P10390 P13880 P13912	180	5		30
Saxagliptin	Tablet 2.5 mg (as hydrochloride)	Oral	Onglyza	AP	MP NP	C15261	P15261	28	5		28
Saxagliptin	Tablet 2.5 mg (as hydrochloride)	Oral	Onglyza	AP	MP NP	C15287	P15287	56	5		28
Saxagliptin	Tablet 5 mg (as hydrochloride)	Oral	Onglyza	AP	MP NP	C15261	P15261	28	5		28
Saxagliptin	Tablet 5 mg (as hydrochloride)	Oral	Onglyza	AP	MP NP	C15287	P15287	56	5		28
Saxagliptin with metformin	Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride	Oral	Kombiglyze XR 2.5/1000	AP	MP NP	C15276	P15276	56	5		56
Saxagliptin with metformin	Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride	Oral	Kombiglyze XR 2.5/1000	AP	MP NP	C15288	P15288	112	5		56
Saxagliptin with metformin	Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride	Oral	Kombiglyze XR 5/1000	AP	MP NP	C15276	P15276	28	5		28
Saxagliptin with metformin	Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride	Oral	Kombiglyze XR 5/1000	AP	MP NP	C15288	P15288	56	5		28
Saxagliptin with metformin	Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride	Oral	Kombiglyze XR 5/500	AP	MP NP	C15276	P15276	28	5		28
Saxagliptin with metformin	Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride	Oral	Kombiglyze XR 5/500	AP	MP NP	C15288	P15288	56	5		28
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C11390 C12392	P11390 P12392	1	0		1
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9064 C9429	P9064 P9429	1	2		1
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9063 C9105 C9431 C10431 C14692	P9063 P9105 P9431 P10431 P14692	1	5		1
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C8831 C9064	P8831 P9064	2	2		2
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C15807 C17590 C17594 C17670	P15807 P17590 C17594 P17670	2	3		2
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9063 C9105 C17671 C18530 C18571 C18583	P9063 P9105 P17671 P18530 P18571 P18583	2	5		2
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9069 C9155 C14655 C14662 C14670 C16382	P9069 P9155 P14655 P14662 P14670 P16382	4	0		1
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C15137 C15158 C18499	P15137 P15158 P18499	5	0		1
Secukinumab	Injection 150 mg in 1 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9069 C9155 C16382 C16779 C16785 C17644 C17680 C17681 C18529 C18582 C18647 C18653	P9069 P9155 P16382 P16779 P16785 P17644 P17680 P17681 P18529 P18582 P18647 P18653	8	0		2
Secukinumab	Injection 300 mg in 2 mL pre-filled pen	Injection	Cosentyx	NV	MP	C8831 C9064 C9429	P8831 P9064 P9429	1	2		1
Secukinumab	Injection 300 mg in 2 mL pre-filled pen	Injection	Cosentyx	NV	MP	C15807 C17590 C17594 C17670	P15807 P17590 P17594 P17670	1	3		1
Secukinumab	Injection 300 mg in 2 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9063 C9105 C9431 C14692 C17671 C18530 C18571 C18583	P9063 P9105 P9431 P14692 P17671 P18530 P18571 P18583	1	5		1
Secukinumab	Injection 300 mg in 2 mL pre-filled pen	Injection	Cosentyx	NV	MP	C9069 C9155 C14655 C14662 C14670 C16382 C16779 C16785 C17644 C17680 C17681 C18529 C18582 C18647 C18653	P9069 P9155 P14655 P14662 P14670 P16382 P16779 P16785 P17644 P17680 P17681 P18529 P18582 P18647 P18653	4	0		1
Selegiline	Tablet containing selegiline hydrochloride 5 mg	Oral	Eldepryl	OX	MP NP	C16541	P16541	100	5		100
Selegiline	Tablet containing selegiline hydrochloride 5 mg	Oral	Eldepryl	OX	MP NP	C16538	P16538	200	5		100
Selexipag	Tablet 200 micrograms	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 200 micrograms	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		140	D(100)
Selexipag	Tablet 400 micrograms	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 600 micrograms	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 800 micrograms	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 1 mg	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 1.2 mg	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 1.4 mg	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selexipag	Tablet 1.6 mg	Oral	Uptravi	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Selinexor	Tablet 20 mg	Oral	Xpovio	TG	MP	C14021 C14045	P14021 P14045	16	2		16	D(100)
Selinexor	Tablet 20 mg	Oral	Xpovio	TG	MP	C14023 C14024	P14023 P14024	20	2		20	D(100)
Selinexor	Tablet 20 mg	Oral	Xpovio	TG	MP	C14031 C14039	P14031 P14039	32	2		32	D(100)
Selpercatinib	Tablet 40 mg	Oral	Retevmo	LY	MP	C16270 C19021		56	5		56
Selpercatinib	Tablet 80 mg	Oral	Retevmo	LY	MP	C16282 C19048		112	5		56
Selumetinib	Capsule 10 mg	Oral	Koselugo	XI	MP	C15477 C15490 C15491		60	5		60
Selumetinib	Capsule 25 mg	Oral	Koselugo	XI	MP	C15477 C15490 C15491		60	5		60
Semaglutide	Solution for injection 2 mg in 3 mL pre-filled pen	Injection	Ozempic	NO	MP NP	C15263 C15301	P15263 P15301	1	5		1
Semaglutide	Solution for injection 2 mg in 3 mL pre-filled pen	Injection	Ozempic	NO	MP NP	C18495	P18495	2	5		1
Semaglutide	Solution for injection 4 mg in 3 mL pre-filled pen	Injection	Ozempic	NO	MP NP	C15263 C15301	P15263 P15301	1	5		1
Semaglutide	Solution for injection 4 mg in 3 mL pre-filled pen	Injection	Ozempic	NO	MP NP	C18495	P18495	2	5		1
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	APO-Sertraline	TX	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	APO-Sertraline	TX	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Blooms The Chemist Sertraline	BG	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Blooms The Chemist Sertraline	BG	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Eleva 50	AF	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Eleva 50	AF	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Sertra 50	RW	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Sertra 50	RW	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Sertraline generichealth	GQ	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Sertraline generichealth	GQ	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Sertraline Sandoz	SZ	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Sertraline Sandoz	SZ	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	SERTRALINE-WGR	WG	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	SERTRALINE-WGR	WG	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Setrona	RA	MP NP	C4755	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Setrona	RA	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Zoloft	GO	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 50 mg (as hydrochloride)	Oral	Zoloft	GO	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	APO-Sertraline	TX	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	APO-Sertraline	TX	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Blooms The Chemist Sertraline	BG	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Blooms The Chemist Sertraline	BG	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Eleva 100	AF	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Eleva 100	AF	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Sertra 100	RW	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Sertra 100	RW	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Sertraline generichealth	GQ	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Sertraline generichealth	GQ	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Sertraline Sandoz	SZ	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Sertraline Sandoz	SZ	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	SERTRALINE-WGR	WG	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	SERTRALINE-WGR	WG	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Setrona	RA	MP NP	C4755	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Setrona	RA	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Zoloft	GO	MP NP	C4755 C6277 C6289	P4755 P6277 P6289	30	5		30
Sertraline	Tablet 100 mg (as hydrochloride)	Oral	Zoloft	GO	MP NP	C15582 C15583 C15666	P15582 P15583 P15666	60	2		30
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMER	XT	MP NP	C5491	P5491	180	5		180
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMER	XT	MP	C5530 C9762	P5530 P9762	360	5		180	C(100)
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMER	XT	MP NP	C14872	P14872	360	5		180
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	Sevelamer Lupin	GQ	MP NP	C5491	P5491	180	5		180
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	Sevelamer Lupin	GQ	MP	C5530 C9762	P5530 P9762	360	5		180	C(100)
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	Sevelamer Lupin	GQ	MP NP	C14872	P14872	360	5		180
Sevelamer	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel	GZ	MP NP	C5491	P5491	180	5		180
Sevelamer	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel	GZ	MP NP	C14872	P14872	360	5		180
Sevelamer	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel	GZ	MP	C5530 C9762	P5530 P9762	360	5		180	C(100)
Sildenafil	Tablet 20 mg (as citrate)	Oral	SILDATIO PHT	RW	MP	See Note 3	See Note 3	See Note 3	See Note 3		90	D(100)
Sildenafil	Tablet 20 mg (as citrate)	Oral	Sildenafil PHT APOTEX	TY	MP	See Note 3	See Note 3	See Note 3	See Note 3		90	D(100)
Sildenafil	Tablet 20 mg (as citrate)	Oral	SILDENAFIL PHT ARX	XT	MP	See Note 3	See Note 3	See Note 3	See Note 3		90	D(100)
Sildenafil	Tablet 20 mg (as citrate)	Oral	Sildenafil Sandoz PHT 20	SZ	MP	See Note 3	See Note 3	See Note 3	See Note 3		90	D(100)
Siltuximab	Powder for injection 100 mg	Injection	Sylvant	RJ	MP	C12585 C12594		2	4		1	D(100)
Siltuximab	Powder for injection 400 mg	Injection	Sylvant	RJ	MP	C12585 C12594		2	4		1	D(100)
Simvastatin	Tablet 5 mg	Oral	Simvastatin Sandoz	SZ	MP NP			30	5		30
Simvastatin	Tablet 5 mg	Oral	Simvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Simvastatin	Tablet 5 mg	Oral	Zimstat	AF	MP NP			30	5		30
Simvastatin	Tablet 5 mg	Oral	Zimstat	AF	MP NP		P14238	60	5		30
Simvastatin	Tablet 10 mg	Oral	APO-Simvastatin	TX	MP NP			30	5		30
Simvastatin	Tablet 10 mg	Oral	APO-Simvastatin	TX	MP NP		P14238	60	5		30
Simvastatin	Tablet 10 mg	Oral	Simvar 10	RW	MP NP			30	5		30
Simvastatin	Tablet 10 mg	Oral	Simvar 10	RW	MP NP		P14238	60	5		30
Simvastatin	Tablet 10 mg	Oral	Simvastatin Sandoz	SZ	MP NP			30	5		30
Simvastatin	Tablet 10 mg	Oral	Simvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Simvastatin	Tablet 10 mg	Oral	SIMVASTATIN-WGR	WG	MP NP			30	5		30
Simvastatin	Tablet 10 mg	Oral	SIMVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Simvastatin	Tablet 10 mg	Oral	Zimstat	AF	MP NP			30	5		30
Simvastatin	Tablet 10 mg	Oral	Zimstat	AF	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	APO-Simvastatin	TX	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	APO-Simvastatin	TX	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	Lipex 20	AL	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	Lipex 20	AL	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	Simvar 20	RW	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	Simvar 20	RW	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	Simvastatin Sandoz	SZ	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	Simvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	SIMVASTATIN-WGR	WG	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	SIMVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	Zimstat	AF	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	Zimstat	AF	MP NP		P14238	60	5		30
Simvastatin	Tablet 20 mg	Oral	Zocor	MQ	MP NP			30	5		30
Simvastatin	Tablet 20 mg	Oral	Zocor	MQ	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	APO-Simvastatin	TX	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	APO-Simvastatin	TX	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	Lipex 40	AL	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	Lipex 40	AL	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	Simvar 40	RW	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	Simvar 40	RW	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	Simvastatin Sandoz	SZ	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	Simvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	SIMVASTATIN-WGR	WG	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	SIMVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	Zimstat	AF	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	Zimstat	AF	MP NP		P14238	60	5		30
Simvastatin	Tablet 40 mg	Oral	Zocor	MQ	MP NP			30	5		30
Simvastatin	Tablet 40 mg	Oral	Zocor	MQ	MP NP		P14238	60	5		30
Simvastatin	Tablet 80 mg	Oral	APO-Simvastatin	TX	MP NP			30	5		30
Simvastatin	Tablet 80 mg	Oral	APO-Simvastatin	TX	MP NP		P14238	60	5		30
Simvastatin	Tablet 80 mg	Oral	Simvar 80	RW	MP NP			30	5		30
Simvastatin	Tablet 80 mg	Oral	Simvar 80	RW	MP NP		P14238	60	5		30
Simvastatin	Tablet 80 mg	Oral	Simvastatin Sandoz	SZ	MP NP			30	5		30
Simvastatin	Tablet 80 mg	Oral	Simvastatin Sandoz	SZ	MP NP		P14238	60	5		30
Simvastatin	Tablet 80 mg	Oral	SIMVASTATIN-WGR	WG	MP NP			30	5		30
Simvastatin	Tablet 80 mg	Oral	SIMVASTATIN-WGR	WG	MP NP		P14238	60	5		30
Simvastatin	Tablet 80 mg	Oral	Zimstat	AF	MP NP			30	5		30
Simvastatin	Tablet 80 mg	Oral	Zimstat	AF	MP NP		P14238	60	5		30
Siponimod	Tablet 250 micrograms (as hemifumarate)	Oral	Mayzent	NV	MP NP	C16303 C16347		12	0		12
Siponimod	Tablet 1 mg (as hemifumarate)	Oral	Mayzent	NV	MP NP	C16303 C16347		28	5		28
Siponimod	Tablet 2 mg (as hemifumarate)	Oral	Mayzent	NV	MP NP	C16303 C16347		28	5		28
Sirolimus	Oral solution 1 mg per mL, 60 mL	Oral	Rapamune	PF	MP			1	3		1
Sirolimus	Oral solution 1 mg per mL, 60 mL	Oral	Rapamune	PF	MP		P14238	2	3		1
Sirolimus	Tablet 0.5 mg	Oral	Rapamune	PF	MP			100	3		100
Sirolimus	Tablet 0.5 mg	Oral	Rapamune	PF	MP		P14238	200	3		100
Sirolimus	Tablet 1 mg	Oral	Rapamune	PF	MP			100	3		100
Sirolimus	Tablet 1 mg	Oral	Rapamune	PF	MP		P14238	200	3		100
Sirolimus	Tablet 2 mg	Oral	Rapamune	PF	MP			100	3		100
Sirolimus	Tablet 2 mg	Oral	Rapamune	PF	MP		P14238	200	3		100
Sitagliptin	Tablet 25 mg	Oral	Januvia	MK	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Januvia	MK	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin Lupin	GQ	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin Lupin	GQ	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin Mylan	AF	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin Mylan	AF	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin Sandoz Pharma	SZ	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin Sandoz Pharma	SZ	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin SUN	RA	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitagliptin SUN	RA	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitaglo	CR	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Sitaglo	CR	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 25 mg	Oral	Xelevia	XT	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 25 mg	Oral	Xelevia	XT	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Januvia	MK	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Januvia	MK	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin Lupin	GQ	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin Lupin	GQ	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin Mylan	AF	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin Mylan	AF	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin Sandoz Pharma	SZ	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin Sandoz Pharma	SZ	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin SUN	RA	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitagliptin SUN	RA	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitaglo	CR	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Sitaglo	CR	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 50 mg	Oral	Xelevia	XT	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 50 mg	Oral	Xelevia	XT	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Januvia	MK	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Januvia	MK	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin Lupin	GQ	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin Lupin	GQ	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin Mylan	AF	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin Mylan	AF	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin Sandoz Pharma	SZ	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin Sandoz Pharma	SZ	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin SUN	RA	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitagliptin SUN	RA	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitaglo	CR	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Sitaglo	CR	MP NP	C15287	P15287	56	5		28
Sitagliptin	Tablet 100 mg	Oral	Xelevia	XT	MP NP	C15261	P15261	28	5		28
Sitagliptin	Tablet 100 mg	Oral	Xelevia	XT	MP NP	C15287	P15287	56	5		28
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet XR	MK	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet XR	MK	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz XR	SZ	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz XR	SZ	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR KND	CR	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR KND	CR	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR Mylan	AL	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR Mylan	AL	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet XR	MK	MP NP	C15276	P15276	28	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet XR	MK	MP NP	C15288	P15288	56	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz XR	SZ	MP NP	C15276	P15276	28	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz XR	SZ	MP NP	C15288	P15288	56	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR KND	CR	MP NP	C15276	P15276	28	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR KND	CR	MP NP	C15288	P15288	56	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR Mylan	AL	MP NP	C15276	P15276	28	5		28
Sitagliptin with metformin	Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin XR Mylan	AL	MP NP	C15288	P15288	56	5		28
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/1000	BG	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/1000	BG	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet	MK	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Janumet	MK	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	SITAGLIPTIN/METFORMIN 50/1000 SUN	RA	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	SITAGLIPTIN/METFORMIN 50/1000 SUN	RA	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Mylan 50/1000	AF	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Mylan 50/1000	AF	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz	SZ	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz	SZ	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	SITAGLO-MET	CR	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	SITAGLO-MET	CR	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Velmetia	XT	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride	Oral	Velmetia	XT	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/500	BG	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/500	BG	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Janumet	MK	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Janumet	MK	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	SITAGLIPTIN/METFORMIN 50/500 SUN	RA	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	SITAGLIPTIN/METFORMIN 50/500 SUN	RA	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Mylan 50/500	AF	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Mylan 50/500	AF	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz	SZ	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz	SZ	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	SITAGLO-MET	CR	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	SITAGLO-MET	CR	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Velmetia	XT	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride	Oral	Velmetia	XT	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/850	BG	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Blooms The Chemist Sitagliptin/Metformin 50/850	BG	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Janumet	MK	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Janumet	MK	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	SITAGLIPTIN/METFORMIN 50/850 SUN	RA	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	SITAGLIPTIN/METFORMIN 50/850 SUN	RA	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Mylan 50/850	AF	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Mylan 50/850	AF	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz	SZ	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Sitagliptin/Metformin Sandoz	SZ	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	SITAGLO-MET	CR	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	SITAGLO-MET	CR	MP NP	C15288	P15288	112	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Velmetia	XT	MP NP	C15276	P15276	56	5		56
Sitagliptin with metformin	Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride	Oral	Velmetia	XT	MP NP	C15288	P15288	112	5		56
Sodium acid phosphate	Tablet, compound effervescent, equivalent to 500 mg phosphorus	Oral	PHOSPHATE PHEBRA	FG	MP NP	C5089 C5095 C5114 C5123	P5089 P5095 P5114 P5123	100	5		100
Sodium acid phosphate	Tablet, compound effervescent, equivalent to 500 mg phosphorus	Oral	PHOSPHATE PHEBRA	FG	MP NP	C14874 C14921 C14922 C14962	P14874 P14921 P14922 P14962	200	5		100
Sodium bicarbonate	Capsule 840 mg	Oral	Sodibic	AS	MP NP			100	2		100
Sodium bicarbonate	Capsule 840 mg	Oral	Sodibic	AS	MP NP		P14238	200	2		100
Sodium phenylbutyrate	Granules 483 mg per g, 174 g	Oral	Pheburane	OH	MP NP	C9919 C9993		3	5	V9919 V9993	1
Sofosbuvir with velpatasvir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir	Oral	Epclusa	GI	MP NP	C5969		28	2		28
Sofosbuvir with velpatasvir and voxilaprevir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir and 100 mg voxilaprevir	Oral	Vosevi	GI	MP NP	C10248		28	2		28
Somapacitan	Injection 10 mg in 1.5 mL single use pre-filled pen	Injection	Sogroya	NO	MP	C18217 C18223 C18224 C18363 C18367 C18409 C18410 C18411 C18444 C18445 C18446 C18447 C18449 C18477		See Note 3	See Note 3		1	D(100)
Somapacitan	Injection 15 mg in 1.5 mL single use pre-filled pen	Injection	Sogroya	NO	MP	C18217 C18223 C18224 C18363 C18367 C18409 C18410 C18411 C18444 C18445 C18446 C18447 C18449 C18477		See Note 3	See Note 3		1	D(100)
Somatrogon	Injection 24 mg in 1.2 mL single use pre-filled pen	Injection	Ngenla	PF	MP	C18217 C18223 C18224 C18363 C18367 C18409 C18410 C18411 C18444 C18445 C18446 C18447 C18449 C18477		See Note 3	See Note 3		1	D(100)
Somatrogon	Injection 60 mg in 1.2 mL single use pre-filled pen	Injection	Ngenla	PF	MP	C18217 C18223 C18224 C18363 C18367 C18409 C18410 C18411 C18444 C18445 C18446 C18447 C18449 C18477		See Note 3	See Note 3		1	D(100)
Somatropin	Injection 0.4 mg (1.2 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 0.6 mg (1.8 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 0.8 mg (2.4 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 1 mg (3 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 1.2 mg (3.6 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 1.4 mg (4.2 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 1.6 mg (4.8 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 1.8 mg (5.4 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Injection 2 mg (6 i.u.) with diluent in single use syringe (without preservative)	Injection	Genotropin MiniQuick	PF	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311		See Note 3	See Note 3		7	D(100)
Somatropin	Powder for injection 5 mg (15 i.u.) with diluent in pre-filled pen (with preservative)	Injection	Genotropin GoQuick	PF	MP	C14366 C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311 C18914 C18917 C18920		See Note 3	See Note 3		1	D(100)
Somatropin	Powder for injection 12 mg (36 i.u.) with diluent in pre-filled pen (with preservative)	Injection	Genotropin GoQuick	PF	MP	C14366 C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17157 C17158 C17160 C17162 C17166 C17167 C17171 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17219 C17220 C17222 C17226 C17227 C17231 C17232 C17242 C17250 C17252 C17255 C17256 C17258 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C17311 C18914 C18917 C18920		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Omnitrope Surepal 5	SZ	MP	C17137 C17149 C17154 C17155 C17162 C17168 C17175 C17176 C17179 C17180 C17182 C17186 C17190 C17195 C17197 C17212 C17213 C17214 C17229 C17230 C17231 C17237 C17238 C17241 C17253 C17255 C17262 C17265 C17294 C17300 C17301 C17304 C17307 C17308 C17309 C17310 C17332 C17333 C17340 C17365 C17366 C17369 C17380 C17388		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Scitropin A	SA	MP	C17137 C17149 C17154 C17155 C17162 C17168 C17175 C17176 C17179 C17180 C17182 C17186 C17190 C17195 C17197 C17212 C17213 C17214 C17229 C17230 C17231 C17237 C17238 C17241 C17253 C17255 C17262 C17265 C17294 C17300 C17301 C17304 C17307 C17308 C17309 C17310 C17332 C17333 C17340 C17365 C17366 C17369 C17380 C17388		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen	Injection	Norditropin FlexPro	NO	MP	C14366 C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17158 C17160 C17162 C17166 C17167 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17220 C17226 C17227 C17231 C17232 C17242 C17248 C17250 C17252 C17255 C17256 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306 C18914 C18917 C18920		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 6 mg (18 i.u.) in 1.03 mL cartridge (with preservative)	Injection	Saizen	SG	MP	C14366 C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17149 C17151 C17158 C17160 C17162 C17166 C17167 C17182 C17186 C17187 C17188 C17189 C17190 C17195 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17220 C17226 C17227 C17231 C17241 C17242 C17250 C17252 C17255 C17256 C17259 C17261 C17263 C17292 C17293 C17298 C17305 C17306 C17309 C18914 C18917 C18920		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Omnitrope Surepal 10	SZ	MP	C17137 C17149 C17154 C17155 C17162 C17168 C17175 C17176 C17179 C17180 C17182 C17186 C17190 C17195 C17197 C17212 C17213 C17214 C17229 C17230 C17231 C17237 C17238 C17241 C17253 C17255 C17262 C17265 C17294 C17300 C17301 C17304 C17307 C17308 C17309 C17310 C17332 C17333 C17340 C17365 C17366 C17369 C17380 C17388		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative)	Injection	SciTropin A	SA	MP	C17137 C17149 C17154 C17155 C17162 C17168 C17175 C17176 C17179 C17180 C17182 C17186 C17190 C17195 C17197 C17212 C17213 C17214 C17229 C17230 C17231 C17237 C17238 C17241 C17253 C17255 C17262 C17265 C17294 C17300 C17301 C17304 C17307 C17308 C17309 C17310 C17332 C17333 C17340 C17365 C17366 C17369 C17380 C17388		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 10 mg (30 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen	Injection	Norditropin FlexPro	NO	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17158 C17160 C17162 C17166 C17167 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17220 C17226 C17227 C17231 C17232 C17242 C17248 C17250 C17252 C17255 C17256 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 12 mg (36 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Saizen	SG	MP	C14366 C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17149 C17151 C17158 C17160 C17162 C17166 C17167 C17182 C17186 C17187 C17188 C17189 C17190 C17195 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17220 C17226 C17227 C17231 C17241 C17242 C17250 C17252 C17255 C17256 C17259 C17261 C17263 C17292 C17293 C17298 C17305 C17306 C17309 C18914 C18917 C18920		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)	Injection	Omnitrope Surepal 15	SZ	MP	C17137 C17149 C17154 C17155 C17162 C17168 C17175 C17176 C17179 C17180 C17182 C17186 C17190 C17195 C17197 C17212 C17213 C17214 C17229 C17230 C17231 C17237 C17238 C17241 C17253 C17255 C17262 C17265 C17294 C17300 C17301 C17304 C17307 C17308 C17309 C17310 C17332 C17333 C17340 C17365 C17366 C17369 C17380 C17388		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative)	Injection	SciTropin A	SA	MP	C17137 C17149 C17154 C17155 C17162 C17168 C17175 C17176 C17179 C17180 C17182 C17186 C17190 C17195 C17197 C17212 C17213 C17214 C17229 C17230 C17231 C17237 C17238 C17241 C17253 C17255 C17262 C17265 C17294 C17300 C17301 C17304 C17307 C17308 C17309 C17310 C17332 C17333 C17340 C17365 C17366 C17369 C17380 C17388		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 15 mg (45 i.u.) in 1.5 mL cartridge (with preservative) in pre-filled pen	Injection	Norditropin FlexPro	NO	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17151 C17158 C17160 C17162 C17166 C17167 C17186 C17187 C17188 C17189 C17195 C17196 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17220 C17226 C17227 C17231 C17232 C17242 C17248 C17250 C17252 C17255 C17256 C17259 C17261 C17263 C17292 C17293 C17295 C17296 C17298 C17305 C17306		See Note 3	See Note 3		1	D(100)
Somatropin	Solution for injection 20 mg (60 i.u.) in 2.5 mL cartridge (with preservative)	Injection	Saizen	SG	MP	C17136 C17137 C17141 C17142 C17143 C17144 C17148 C17149 C17151 C17158 C17160 C17162 C17166 C17167 C17182 C17186 C17187 C17188 C17189 C17190 C17195 C17197 C17200 C17202 C17203 C17206 C17207 C17210 C17220 C17226 C17227 C17231 C17241 C17242 C17250 C17252 C17255 C17256 C17259 C17261 C17263 C17292 C17293 C17298 C17305 C17306 C17309		See Note 3	See Note 3		1	D(100)
Sonidegib	Capsule 200 mg	Oral	Odomzo	RA	MP	C7491 C18329 C18500		30	3		30
Sorafenib	Tablet 200 mg (as tosilate)	Oral	Nexavar	BN	MP	C8621 C17436 C17504	P8621 P17436 P17504	120	2		60
Sorafenib	Tablet 200 mg (as tosilate)	Oral	Nexavar	BN	MP	C7487	P7487	120	5		60
Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	Rectal	Micolette	AE	MP NP	C5613 C5640 C5685 C5720 C5775 C5776 C5804	P5613 P5640 P5685 P5720 P5775 P5776 P5804	2	2		1
Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	Rectal	Micolette	AE	MP NP	C6139	P6139	2	3		1
Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate	Enemas 3.125 g-450 mg-45 mg in 5 mL, 12	Rectal	Micolette	AE	MP NP	C15572 C15585 C15586 C15629 C15707 C15734 C15735	P15572 P15585 P15586 P15629 P15707 P15734 P15735	4	2		1
Sotalol	Tablet containing sotalol hydrochloride 80 mg	Oral	APX-Sotalol	TY	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 80 mg	Oral	Cardol	AF	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 80 mg	Oral	Solavert	RF	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 80 mg	Oral	Sotacor	RW	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 80 mg	Oral	Sotalol Sandoz	SZ	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 80 mg	Oral	SOTALOL-WGR	WG	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 160 mg	Oral	APX-Sotalol	TY	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 160 mg	Oral	Cardol	AF	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 160 mg	Oral	Solavert	RF	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 160 mg	Oral	Sotacor	RW	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 160 mg	Oral	Sotalol Sandoz	SZ	MP NP	C15967		60	5		60
Sotalol	Tablet containing sotalol hydrochloride 160 mg	Oral	SOTALOL-WGR	WG	MP NP	C15967		60	5		60
Soy protein and fat formula with vitamins and minerals -- carbohydrate free	Oral liquid 384 mL (RCF)	Oral	RCF	AB	MP NP	C6658		120	5		1
Spironolactone	Tablet 25 mg	Oral	Aldactone	PF	MP NP			100	5		100
Spironolactone	Tablet 25 mg	Oral	Aldactone	PF	MP NP		P14238	200	5		100
Spironolactone	Tablet 25 mg	Oral	Spiractin 25	AF	MP NP			100	5		100
Spironolactone	Tablet 25 mg	Oral	Spiractin 25	AF	MP NP		P14238	200	5		100
Spironolactone	Tablet 25 mg	Oral	Spironolactone Viatris 25	AL	MP NP			100	5		100
Spironolactone	Tablet 25 mg	Oral	Spironolactone Viatris 25	AL	MP NP		P14238	200	5		100
Spironolactone	Tablet 100 mg	Oral	Aldactone	PF	MP NP			100	5		100
Spironolactone	Tablet 100 mg	Oral	Aldactone	PF	MP NP		P14238	200	5		100
Spironolactone	Tablet 100 mg	Oral	Spiractin 100	AF	MP NP			100	5		100
Spironolactone	Tablet 100 mg	Oral	Spiractin 100	AF	MP NP		P14238	200	5		100
Spironolactone	Tablet 100 mg	Oral	Spironolactone Viatris 100	AL	MP NP			100	5		100
Spironolactone	Tablet 100 mg	Oral	Spironolactone Viatris 100	AL	MP NP		P14238	200	5		100
Stiripentol	Capsule 250 mg	Oral	Diacomit	EU	MP	C17456		120	3		60
Stiripentol	Capsule 500 mg	Oral	Diacomit	EU	MP	C17456		120	3		60
Stiripentol	Powder for oral suspension 250 mg	Oral	Diacomit	EU	MP	C17456		120	3		60
Stiripentol	Powder for oral suspension 500 mg	Oral	Diacomit	EU	MP	C17456		120	3		60
Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro	CS	MP NP	C5491	P5491	90	5		90
Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro	CS	MP	C5530 C9762	P5530 P9762	180	5		90	C(100)
Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro	CS	MP NP	C14872	P14872	180	5		90
Sulfasalazine	Tablet 500 mg	Oral	Salazopyrin	PF	MP NP	C16524	P16524	200	5		100
Sulfasalazine	Tablet 500 mg	Oral	Salazopyrin	PF	MP NP	C16493	P16493	400	5		100
Sulfasalazine	Tablet 500 mg (enteric coated)	Oral	Pyralin EN	FZ	MP NP	C16524	P16524	200	5		100
Sulfasalazine	Tablet 500 mg (enteric coated)	Oral	Pyralin EN	FZ	MP NP	C16493	P16493	400	5		100
Sulfasalazine	Tablet 500 mg (enteric coated)	Oral	Salazopyrin-EN	PF	MP NP	C16524	P16524	200	5		100
Sulfasalazine	Tablet 500 mg (enteric coated)	Oral	Salazopyrin-EN	PF	MP NP	C16493	P16493	400	5		100
Sulthiame	Tablet 50 mg	Oral	Ospolot	FF	MP NP	C16524	P16524	200	2		200
Sulthiame	Tablet 50 mg	Oral	Ospolot	FF	MP NP	C16493	P16493	400	2		200
Sulthiame	Tablet 200 mg	Oral	Ospolot	FF	MP NP	C16524	P16524	200	2		200
Sulthiame	Tablet 200 mg	Oral	Ospolot	FF	MP NP	C16493	P16493	400	2		200
Sumatriptan	Tablet 50 mg (as succinate)	Oral	APO-Sumatriptan	TX	MP NP	C5141		4	5		2
Sumatriptan	Tablet 50 mg (as succinate)	Oral	APO-Sumatriptan	TX	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Imigran	LN	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Iptam	AL	MP NP	C5141		4	5		2
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Iptam	AL	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Pharmacor Sumatriptan 50	CR	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Sumagraine Migraine Relief	GQ	MP NP	C5141		4	5		2
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Sumatran	OW	MP NP	C5141		4	5		2
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Sumatran	OW	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Sumatriptan generichealth	GQ	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	Sumatriptan Sandoz	SZ	MP NP	C5141		4	5		4
Sumatriptan	Tablet 50 mg (as succinate)	Oral	SUMATRIPTAN-WGR	WG	MP NP	C5141		4	5		4
Sumatriptan	Tablet (fast disintegrating) 50 mg (as succinate)	Oral	Imigran FDT	AS	MP NP	C5141		4	5		4
Sunitinib	Capsule 12.5 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 12.5 mg	Oral	Sunitinib Sandoz	SZ	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 12.5 mg	Oral	Sunitinib Sandoz	SZ	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 12.5 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 12.5 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 12.5 mg	Oral	Sutent	PF	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 12.5 mg	Oral	Sutent	PF	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 12.5 mg	Oral	Sutent	PF	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 12.5 mg	Oral	Sutent	PF	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 12.5 mg	Oral	Sutent	PF	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 25 mg	Oral	ARX-Sunitinib	XT	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 25 mg	Oral	ARX-Sunitinib	XT	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 25 mg	Oral	ARX-Sunitinib	XT	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 25 mg	Oral	ARX-Sunitinib	XT	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 25 mg	Oral	ARX-Sunitinib	XT	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 25 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 25 mg	Oral	Sunitinib Sandoz	SZ	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 25 mg	Oral	Sunitinib Sandoz	SZ	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 25 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 25 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 25 mg	Oral	Sutent	PF	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 25 mg	Oral	Sutent	PF	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 25 mg	Oral	Sutent	PF	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 25 mg	Oral	Sutent	PF	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 25 mg	Oral	Sutent	PF	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 37.5 mg	Oral	ARX-Sunitinib	XT	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 37.5 mg	Oral	ARX-Sunitinib	XT	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 37.5 mg	Oral	ARX-Sunitinib	XT	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 37.5 mg	Oral	ARX-Sunitinib	XT	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 37.5 mg	Oral	ARX-Sunitinib	XT	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 37.5 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 37.5 mg	Oral	Sunitinib Sandoz	SZ	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 37.5 mg	Oral	Sunitinib Sandoz	SZ	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 37.5 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 37.5 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 37.5 mg	Oral	Sutent	PF	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 37.5 mg	Oral	Sutent	PF	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 37.5 mg	Oral	Sutent	PF	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 37.5 mg	Oral	Sutent	PF	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 37.5 mg	Oral	Sutent	PF	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 50 mg	Oral	ARX-Sunitinib	XT	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 50 mg	Oral	ARX-Sunitinib	XT	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 50 mg	Oral	ARX-Sunitinib	XT	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 50 mg	Oral	ARX-Sunitinib	XT	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 50 mg	Oral	ARX-Sunitinib	XT	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 50 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 50 mg	Oral	Sunitinib Sandoz	SZ	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 50 mg	Oral	Sunitinib Sandoz	SZ	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 50 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 50 mg	Oral	Sunitinib Sandoz	SZ	MP NP	C17862	P17862	28	5		28
Sunitinib	Capsule 50 mg	Oral	Sutent	PF	MP NP	C17789	P17789	28	1		28
Sunitinib	Capsule 50 mg	Oral	Sutent	PF	MP	C11878 C19250	P11878 P19250	28	1		28
Sunitinib	Capsule 50 mg	Oral	Sutent	PF	MP	C17614	P17614	28	2		28
Sunitinib	Capsule 50 mg	Oral	Sutent	PF	MP NP	C17856	P17856	28	3		28
Sunitinib	Capsule 50 mg	Oral	Sutent	PF	MP NP	C17862	P17862	28	5		28
Tacrolimus	Capsule 0.5 mg	Oral	Pacrolim	AF	MP			100	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Pacrolim	AF	MP		P14238	200	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Pharmacor Tacrolimus 0.5	CR	MP			100	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Pharmacor Tacrolimus 0.5	CR	MP		P14238	200	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Prograf	LL	MP			100	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Prograf	LL	MP		P14238	200	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Tacrograf	RW	MP			100	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Tacrograf	RW	MP		P14238	200	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Tacrolimus Sandoz	SZ	MP			100	3		100
Tacrolimus	Capsule 0.5 mg	Oral	Tacrolimus Sandoz	SZ	MP		P14238	200	3		100
Tacrolimus	Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP			30	3		30
Tacrolimus	Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP		P14238	60	3		30
Tacrolimus	Capsule 0.5 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP			30	3		30
Tacrolimus	Capsule 0.5 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP		P14238	60	3		30
Tacrolimus	Capsule 0.75 mg	Oral	Tacrolimus Sandoz	SZ	MP			100	3		100
Tacrolimus	Capsule 0.75 mg	Oral	Tacrolimus Sandoz	SZ	MP		P14238	200	3		100
Tacrolimus	Capsule 1 mg	Oral	Pacrolim	AF	MP			100	3		100
Tacrolimus	Capsule 1 mg	Oral	Pacrolim	AF	MP		P14238	200	3		100
Tacrolimus	Capsule 1 mg	Oral	Pharmacor Tacrolimus 1	CR	MP			100	3		100
Tacrolimus	Capsule 1 mg	Oral	Pharmacor Tacrolimus 1	CR	MP		P14238	200	3		100
Tacrolimus	Capsule 1 mg	Oral	Prograf	LL	MP			100	3		100
Tacrolimus	Capsule 1 mg	Oral	Prograf	LL	MP		P14238	200	3		100
Tacrolimus	Capsule 1 mg	Oral	Tacrograf	RW	MP			100	3		100
Tacrolimus	Capsule 1 mg	Oral	Tacrograf	RW	MP		P14238	200	3		100
Tacrolimus	Capsule 1 mg	Oral	Tacrolimus Sandoz	SZ	MP			100	3		100
Tacrolimus	Capsule 1 mg	Oral	Tacrolimus Sandoz	SZ	MP		P14238	200	3		100
Tacrolimus	Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP			60	3		60
Tacrolimus	Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP		P14238	120	3		60
Tacrolimus	Capsule 1 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP			60	3		60
Tacrolimus	Capsule 1 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP		P14238	120	3		60
Tacrolimus	Capsule 2 mg	Oral	Tacrolimus Sandoz	SZ	MP			100	3		100
Tacrolimus	Capsule 2 mg	Oral	Tacrolimus Sandoz	SZ	MP		P14238	200	3		100
Tacrolimus	Capsule 3 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP			50	2		50
Tacrolimus	Capsule 3 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP		P14238	100	2		50
Tacrolimus	Capsule 3 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP			50	2		50
Tacrolimus	Capsule 3 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP		P14238	100	2		50
Tacrolimus	Capsule 5 mg	Oral	Pharmacor Tacrolimus 5	CR	MP			50	3		50
Tacrolimus	Capsule 5 mg	Oral	Pharmacor Tacrolimus 5	CR	MP		P14238	100	3		50
Tacrolimus	Capsule 5 mg	Oral	Prograf	LL	MP			50	3		50
Tacrolimus	Capsule 5 mg	Oral	Prograf	LL	MP		P14238	100	3		50
Tacrolimus	Capsule 5 mg	Oral	Tacrograf	RW	MP			50	3		50
Tacrolimus	Capsule 5 mg	Oral	Tacrograf	RW	MP		P14238	100	3		50
Tacrolimus	Capsule 5 mg	Oral	Tacrolimus Sandoz	SZ	MP			50	3		50
Tacrolimus	Capsule 5 mg	Oral	Tacrolimus Sandoz	SZ	MP		P14238	100	3		50
Tacrolimus	Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP			30	3		30
Tacrolimus	Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	LQ	MP		P14238	60	3		30
Tacrolimus	Capsule 5 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP			30	3		30
Tacrolimus	Capsule 5 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	SZ	MP		P14238	60	3		30
Tacrolimus	Ointment 1 mg per g, 30 g	Application	aZematop	XT	MP NP	C19259		1	1		1
Tadalafil	Tablet 20 mg	Oral	Adcirca	LY	MP	See Note 3	See Note 3	See Note 3	See Note 3		56	D(100)
Tadalafil	Tablet 20 mg	Oral	Tadalca	CR	MP	See Note 3	See Note 3	See Note 3	See Note 3		56	D(100)
Tadalafil	Tablet 20 mg	Oral	TADALIS 20	LR	MP	See Note 3	See Note 3	See Note 3	See Note 3		56	D(100)
Tadalafil	Tablet 20 mg	Oral	Tadalis 20	LR	MP	See Note 3	See Note 3	See Note 3	See Note 3		60	D(100)
Tafamidis	Capsule 61 mg	Oral	Vyndamax	PF	MP	C15303 C18247		30	5		30
Tafasitamab	Powder for I.V. infusion 200 mg	Injection	MINJUVI	XB	MP	C18931 C18976		See Note 3	See Note 3		1	D(100)
Talazoparib	Capsule 100 micrograms (as tosilate)	Oral	Talzenna	PF	MP NP	C17867		30	5		30
Talazoparib	Capsule 250 micrograms (as tosilate)	Oral	Talzenna	PF	MP NP	C17867		30	5		30
Talazoparib	Capsule 350 micrograms (as tosilate)	Oral	Talzenna	PF	MP NP	C17867		30	5		30
Talazoparib	Capsule 500 micrograms (as tosilate)	Oral	Talzenna	PF	MP NP	C17867		30	5		30
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Genox 20	AF	MP NP	C16579	P16579	30	5		30
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Genox 20	AF	MP NP	C16664	P16664	60	5		30
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Genox 20	AF	MP NP	C5522	P5522	60	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Genox 20	AF	MP NP	C14895	P14895	120	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	GenRx Tamoxifen	GX	MP NP	C5522	P5522	60	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	GenRx Tamoxifen	GX	MP NP	C14895	P14895	120	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Nolvadex-D	AP	MP NP	C16579	P16579	30	5		30
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Nolvadex-D	AP	MP NP	C5522 C16664	P5522 P16664	60	5		30
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Nolvadex-D	AP	MP NP	C14895	P14895	120	5		30
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Tamosin	OX	MP NP	C5522	P5522	60	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Tamosin	OX	MP NP	C14895	P14895	120	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Tamoxifen Sandoz	SZ	MP NP	C5522	P5522	60	5		60
Tamoxifen	Tablet 20 mg (as citrate)	Oral	Tamoxifen Sandoz	SZ	MP NP	C14895	P14895	120	5		60
Tapentadol	Tablet (modified release) 50 mg (as hydrochloride)	Oral	Palexia SR	CS	MP NP	C10748 C10752 C10755		28	0	V10748 V10752 V10755	28
Tapentadol	Tablet (modified release) 100 mg (as hydrochloride)	Oral	Palexia SR	CS	MP NP	C10748 C10752 C10755		28	0	V10748 V10752 V10755	28
Tapentadol	Tablet (modified release) 150 mg (as hydrochloride)	Oral	Palexia SR	CS	MP NP	C10748 C10752 C10755		28	0	V10748 V10752 V10755	28
Tapentadol	Tablet (modified release) 200 mg (as hydrochloride)	Oral	Palexia SR	CS	MP NP	C10748 C10752 C10755		28	0	V10748 V10752 V10755	28
Tapentadol	Tablet (modified release) 250 mg (as hydrochloride)	Oral	Palexia SR	CS	MP NP	C10748 C10752 C10755		28	0	V10748 V10752 V10755	28
Tebentafusp	Solution concentrate for I.V. infusion 100 micrograms in 0.5 mL	Injection	Kimmtrak	WM	MP	C14813 C14821 C14825 C15085		See Note 3	See Note 3		1	D(100)
Teduglutide	Powder for injection 5 mg with diluent	Injection	Revestive	TK	MP	See Note 3	See Note 3	See Note 3	See Note 3		28	D(100)
Telmisartan	Tablet 40 mg	Oral	APO-Telmisartan	TX	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	APO-Telmisartan	TX	MP NP		P14238	56	5		28
Telmisartan	Tablet 40 mg	Oral	Micardis	BY	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	Micardis	BY	MP NP		P14238	56	5		28
Telmisartan	Tablet 40 mg	Oral	Mizart	AF	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	Mizart	AF	MP NP		P14238	56	5		28
Telmisartan	Tablet 40 mg	Oral	Pharmacor Telmisartan 40	CR	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	Pharmacor Telmisartan 40	CR	MP NP		P14238	56	5		28
Telmisartan	Tablet 40 mg	Oral	Telmisartan Sandoz	SZ	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	Telmisartan Sandoz	SZ	MP NP		P14238	56	5		28
Telmisartan	Tablet 40 mg	Oral	TELMISARTAN-WGR	WG	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	TELMISARTAN-WGR	WG	MP NP		P14238	56	5		28
Telmisartan	Tablet 40 mg	Oral	Teltartan	RW	MP NP			28	5		28
Telmisartan	Tablet 40 mg	Oral	Teltartan	RW	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	APO-Telmisartan	TX	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	APO-Telmisartan	TX	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	Micardis	BY	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	Micardis	BY	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	Mizart	AF	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	Mizart	AF	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	Pharmacor Telmisartan 80	CR	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	Pharmacor Telmisartan 80	CR	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	Telmisartan Sandoz	SZ	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	Telmisartan Sandoz	SZ	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	TELMISARTAN-WGR	WG	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	TELMISARTAN-WGR	WG	MP NP		P14238	56	5		28
Telmisartan	Tablet 80 mg	Oral	Teltartan	RW	MP NP			28	5		28
Telmisartan	Tablet 80 mg	Oral	Teltartan	RW	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 40 mg-5 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 40 mg-5 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 40 mg-5 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 40 mg-5 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 40 mg-5 mg (as besilate)	Oral	Twilem 40/5	AL	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 40 mg-5 mg (as besilate)	Oral	Twilem 40/5	AL	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 40 mg-10 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 40 mg-10 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 40 mg-10 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 40 mg-10 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 40 mg-10 mg (as besilate)	Oral	Twilem 40/10	AL	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 40 mg-10 mg (as besilate)	Oral	Twilem 40/10	AL	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 80 mg-5 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 80 mg-5 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 80 mg-5 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 80 mg-5 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 80 mg-5 mg (as besilate)	Oral	Twilem 80/5	AL	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 80 mg-5 mg (as besilate)	Oral	Twilem 80/5	AL	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 80 mg-10 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 80 mg-10 mg (as besilate)	Oral	ARX-Telmisartan/Amlodipine	XT	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 80 mg-10 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 80 mg-10 mg (as besilate)	Oral	Telmisartan/Amlodipine Viatris	AF	MP NP		P14238	56	5		28
Telmisartan with amlodipine	Tablet 80 mg-10 mg (as besilate)	Oral	Twilem 80/10	AL	MP NP			28	5		28
Telmisartan with amlodipine	Tablet 80 mg-10 mg (as besilate)	Oral	Twilem 80/10	AL	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	APO-Telmisartan HCTZ 40/12.5	TX	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	APO-Telmisartan HCTZ 40/12.5	TX	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Micardis Plus 40/12.5 mg	BY	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Micardis Plus 40/12.5 mg	BY	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Mizart HCT 40/12.5 mg	AF	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Mizart HCT 40/12.5 mg	AF	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Telmisartan/HCT Sandoz	SZ	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Telmisartan/HCT Sandoz	SZ	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	TELMISARTAN HCTZ-WGR 40/12.5	WG	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	TELMISARTAN HCTZ-WGR 40/12.5	WG	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Teltartan HCT 40/12.5	RW	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 40 mg-12.5 mg	Oral	Teltartan HCT 40/12.5	RW	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	APO-Telmisartan HCTZ 80/12.5	TX	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	APO-Telmisartan HCTZ 80/12.5	TX	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Micardis Plus 80/12.5 mg	BY	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Micardis Plus 80/12.5 mg	BY	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Mizart HCT 80/12.5 mg	AF	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Mizart HCT 80/12.5 mg	AF	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Telmisartan/HCT Sandoz	SZ	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Telmisartan/HCT Sandoz	SZ	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	TELMISARTAN HCTZ-WGR 80/12.5	WG	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	TELMISARTAN HCTZ-WGR 80/12.5	WG	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Teltartan HCT 80/12.5	RW	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Teltartan HCT 80/12.5	RW	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	APO-Telmisartan HCTZ 80/25	TX	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	APO-Telmisartan HCTZ 80/25	TX	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Micardis Plus 80/25 mg	BY	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Micardis Plus 80/25 mg	BY	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Mizart HCT 80/25 mg	AF	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Mizart HCT 80/25 mg	AF	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Telmisartan/HCT Sandoz	SZ	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Telmisartan/HCT Sandoz	SZ	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	TELMISARTAN HCTZ-WGR 80/25	WG	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	TELMISARTAN HCTZ-WGR 80/25	WG	MP NP		P14238	56	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Teltartan HCT 80/25	RW	MP NP			28	5		28
Telmisartan with hydrochlorothiazide	Tablet 80 mg-25 mg	Oral	Teltartan HCT 80/25	RW	MP NP		P14238	56	5		28
Temazepam	Tablet 10 mg	Oral	APO-Temazepam	TX	PDP			25	0		25
Temazepam	Tablet 10 mg	Oral	APO-Temazepam	TX	MP NP MW		P16279	25	0		25
Temazepam	Tablet 10 mg	Oral	APO-Temazepam	TX	MP NP		P6175	50 CN6175	3 CN6175		25
Temazepam	Tablet 10 mg	Oral	APO-Temazepam	TX	MP NP		P5941 P5950 P16692	50CN5941 CN5950 CN16692	5CN5941 CN5950 CN16692		25
Temazepam	Tablet 10 mg	Oral	Normison	AS	PDP			25	0		25
Temazepam	Tablet 10 mg	Oral	Normison	AS	MP NP MW		P16279	25	0		25
Temazepam	Tablet 10 mg	Oral	Normison	AS	MP NP		P6175	50 CN6175	3 CN6175		25
Temazepam	Tablet 10 mg	Oral	Normison	AS	MP NP		P5941 P5950 P16692	50CN5941 CN5950 CN16692	5CN5941 CN5950 CN16692		25
Temazepam	Tablet 10 mg	Oral	Temaze	AF	PDP			25	0		25
Temazepam	Tablet 10 mg	Oral	Temaze	AF	MP NP MW		P16279	25	0		25
Temazepam	Tablet 10 mg	Oral	Temaze	AF	MP NP		P6175	50 CN6175	3 CN6175		25
Temazepam	Tablet 10 mg	Oral	Temaze	AF	MP NP		P5941 P5950 P16692	50CN5941 CN5950 CN16692	5CN5941 CN5950 CN16692		25
Temazepam	Tablet 10 mg	Oral	TEMAZEPAM-WGR	WG	PDP			25	0		25
Temazepam	Tablet 10 mg	Oral	TEMAZEPAM-WGR	WG	MP NP MW		P16279	25	0		25
Temazepam	Tablet 10 mg	Oral	TEMAZEPAM-WGR	WG	MP NP		P6175	50 CN6175	3 CN6175		25
Temazepam	Tablet 10 mg	Oral	TEMAZEPAM-WGR	WG	MP NP		P5941 P5950 P16692	50CN5941 CN5950 CN16692	5CN5941 CN5950 CN16692		25
Temazepam	Tablet 10 mg	Oral	Temtabs	LN	PDP			25	0		25
Temazepam	Tablet 10 mg	Oral	Temtabs	LN	MP NP MW		P16279	25	0		25
Temazepam	Tablet 10 mg	Oral	Temtabs	LN	MP NP		P6175	50 CN6175	3 CN6175		25
Temazepam	Tablet 10 mg	Oral	Temtabs	LN	MP NP		P5941 P5950 P16692	50CN5941 CN5950 CN16692	5CN5941 CN5950 CN16692		25
Temozolomide	Capsule 5 mg	Oral	APO-Temozolomide	TX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 5 mg	Oral	APO-Temozolomide	TX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 5 mg	Oral	Temizole 5	AL	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 5 mg	Oral	Temizole 5	AL	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 5 mg	Oral	Temozolomide Juno	JX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 5 mg	Oral	Temozolomide Juno	JX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 20 mg	Oral	APO-Temozolomide	TX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 20 mg	Oral	APO-Temozolomide	TX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 20 mg	Oral	Temizole 20	AL	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 20 mg	Oral	Temizole 20	AL	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 20 mg	Oral	Temozolomide Juno	JX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 20 mg	Oral	Temozolomide Juno	JX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 100 mg	Oral	APO-Temozolomide	TX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 100 mg	Oral	APO-Temozolomide	TX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 100 mg	Oral	Temizole 100	AL	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 100 mg	Oral	Temizole 100	AL	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 100 mg	Oral	Temozolomide Juno	JX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 100 mg	Oral	Temozolomide Juno	JX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 140 mg	Oral	APO-Temozolomide	TX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 140 mg	Oral	APO-Temozolomide	TX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 140 mg	Oral	Temizole 140	AL	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 140 mg	Oral	Temizole 140	AL	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 140 mg	Oral	Temozolomide Juno	JX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 140 mg	Oral	Temozolomide Juno	JX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 180 mg	Oral	APO-Temozolomide	TX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 180 mg	Oral	APO-Temozolomide	TX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 180 mg	Oral	Temozolomide Juno	JX	MP NP	C17848	P17848	5	5		5
Temozolomide	Capsule 180 mg	Oral	Temozolomide Juno	JX	MP NP	C17854	P17854	15	2		5
Temozolomide	Capsule 250 mg	Oral	APO-Temozolomide	TX	MP NP	C17848		5	5		5
Temozolomide	Capsule 250 mg	Oral	Temizole 250	AL	MP NP	C17848		5	5		5
Temozolomide	Capsule 250 mg	Oral	Temozolomide Juno	JX	MP NP	C17848		5	5		5
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	TENOFOVIR ARX	XT	MP NP	C10362	P10362	60	2		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	TENOFOVIR ARX	XT	MP NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Tenofovir Sandoz	SZ	MP NP	C10362	P10362	60	2		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Tenofovir Sandoz	SZ	MP NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Viatris	AL	MP NP	C10362	P10362	60	2		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Viatris	AL	MP NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	GQ	MP NP	C10362	P10362	60	2		30	D(100)
Tenofovir	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	GQ	MP NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5		30	D(100)
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat	Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg	Oral	Genvoya	GI	MP NP	C4470 C4522		60	5		30	D(100)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200	LR	MP NP	C11143	P11143	30	5		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200	LR	MP NP	C18908	P18908	60	2		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200	LR	MP NP	C6985 C6986	P6985 P6986	60	5		30	C(100)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 APX	XW	MP NP	C11143	P11143	30	5		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 APX	XW	MP NP	C18908	P18908	60	2		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 APX	XW	MP NP	C6985 C6986	P6985 P6986	60	5		30	C(100)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 ARX	XT	MP NP	C11143	P11143	30	5		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 ARX	XT	MP NP	C18908	P18908	60	2		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 ARX	XT	MP NP	C6985 C6986	P6985 P6986	60	5		30	C(100)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz Pharma 300/200	HX	MP NP	C11143	P11143	30	5		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz Pharma 300/200	HX	MP NP	C6985 C6986	P6985 P6986	60	5		30	C(100)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200	AL	MP NP	C11143	P11143	30	5		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200	AL	MP NP	C18908	P18908	60	2		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200	AL	MP NP	C6985 C6986	P6985 P6986	60	5		30	C(100)
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200	SZ	MP NP	C11143	P11143	30	5		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200	SZ	MP NP	C18908	P18908	60	2		30
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200	SZ	MP NP	C6985 C6986	P6985 P6986	60	5		30	C(100)
Tenofovir with emtricitabine and efavirenz	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg (s19A)	Oral	Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablet 600 mg/200 mg/300 mg (Camber, USA)	QY	MP NP	C4470 C4522		60	5		30	D(100)
Tenofovir with emtricitabine and efavirenz	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg and efavirenz 600 mg	Oral	Tenofovir Disoproxil Emtricitabine Efavirenz Viatris 300/200/600	AL	MP NP	C4470 C4522		60	5		30	D(100)
Tepotinib	Tablet 225 mg	Oral	Tepmetko	SG	MP	C13434 C13441		60	5		60
Terbinafine	Cream containing terbinafine hydrochloride 10 mg per g, 15 g	Application	Lamisil	NP	MP NP	C6412 C6434		2	3		1
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	APO-Terbinafine	TX	MP NP	C6404 C6453	P6404 P6453	42	0		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	APO-Terbinafine	TX	MP NP	C6395	P6395	42	1		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Tamsil	RW	MP NP	C6404 C6453	P6404 P6453	42	0		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Tamsil	RW	MP NP	C6395	P6395	42	1		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Terbinafine-DRLA	RZ	MP NP	C6404 C6453	P6404 P6453	42	0		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Terbinafine-DRLA	RZ	MP NP	C6395	P6395	42	1		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Terbinafine Sandoz	SZ	MP NP	C6404 C6453	P6404 P6453	42	0		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Terbinafine Sandoz	SZ	MP NP	C6395	P6395	42	1		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	TERBINAFINE-WGR	WG	MP NP	C6404 C6453	P6404 P6453	42	0		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	TERBINAFINE-WGR	WG	MP NP	C6395	P6395	42	1		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Tinasil	AF	MP NP	C6404 C6453	P6404 P6453	42	0		42
Terbinafine	Tablet 250 mg (as hydrochloride)	Oral	Tinasil	AF	MP NP	C6395	P6395	42	1		42
Terbutaline	Injection containing terbutaline sulfate 500 micrograms in 1 mL	Injection	Bricanyl	AP	MP NP			5	0		5
Terbutaline	Powder for oral inhalation in breath actuated device containing terbutaline sulfate 500 micrograms per dose, 120 doses	Inhalation by mouth	Bricanyl Turbuhaler	AP	MP NP	C9828		2	5		1
Teriflunomide	Tablet 14 mg	Oral	APO-TERIFLUNOMIDE	TX	MP NP	C16315 C16323		28	5		28
Teriflunomide	Tablet 14 mg	Oral	Pharmacor Teriflunomide	CR	MP NP	C16315 C16323		28	5		28
Teriflunomide	Tablet 14 mg	Oral	TERIFLAGIO	RW	MP NP	C16315 C16323		28	5		28
Teriflunomide	Tablet 14 mg	Oral	Teriflunomide Dr.Reddy's	RZ	MP NP	C16315 C16323		28	5		28
Teriflunomide	Tablet 14 mg	Oral	Teriflunomide GH	GQ	MP NP	C16315 C16323		28	5		28
Teriflunomide	Tablet 14 mg	Oral	Teriflunomide Sandoz	SZ	MP NP	C16315 C16323		28	5		28
Teriflunomide	Tablet 14 mg	Oral	Terimide	AF	MP NP	C16315 C16323		28	5		28
Teriparatide	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge	Injection	Ritosa	XT	MP	C12270 C19012	P12270 P19012	1	5		1
Teriparatide	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge	Injection	Ritosa	XT	MP	C15536	P15536	2	2		1
Teriparatide	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen	Injection	Teriparatide Lupin	GQ	MP	C12270 C19012	P12270 P19012	1	5		1
Teriparatide	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen	Injection	Teriparatide Lupin	GQ	MP	C15536	P15536	2	2		1
Teriparatide	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen	Injection	Terrosa	FX	MP	C12270 C19012	P12270 P19012	1	5		1
Teriparatide	Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen	Injection	Terrosa	FX	MP	C15536	P15536	2	2		1
Testosterone	I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL	Injection	Gonadron	RA	MP NP	C6324 C6910 C6919 C6933 C6934		1	1		1
Testosterone	I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL	Injection	Reandron 1000	AS	MP NP	C6324 C6910 C6919 C6933 C6934		1	1		1
Testosterone	I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL	Injection	REJUNON 1000	JU	MP NP	C6324 C6910 C6919 C6933 C6934		1	1		1
Testosterone	I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL	Injection	Testosterone ADVZ 1000	BZ	MP NP	C6324 C6910 C6919 C6933 C6934		1	1		1
Testosterone	Transdermal cream 50 mg per mL, 50 mL	Transdermal	AndroForte 5	LX	MP NP	C16166 C16194 C16204 C16211 C16212	P16166 P16194 P16204 P16211 P16212	1	1		1
Testosterone	Transdermal cream 50 mg per mL, 50 mL	Transdermal	AndroForte 5	LX	MP NP	C16186 C16195 C16206 C16207 C16214	P16186 P16195 P16206 P16207 P16214	2	1		1
Testosterone	Transdermal gel 50 mg in 5 g sachet, 30	Transdermal	Testogel	HB	MP NP	C6324 C6910 C6919 C6933 C6934	P6324 P6910 P6919 P6933 P6934	1	5		1
Testosterone	Transdermal gel 50 mg in 5 g sachet, 30	Transdermal	Testogel	HB	MP NP	C14912 C14913 C14955 C14956 C15015	P14912 P14913 P14955 P14956 P15015	2	5		1
Testosterone	Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2	Transdermal	Testogel	HB	MP NP	C6324 C6910 C6919 C6933 C6934	P6324 P6910 P6919 P6933 P6934	1	4		1
Testosterone	Transdermal gel (pump pack) 12.5 mg per 1.25 g dose, 60 doses, 2	Transdermal	Testogel	HB	MP NP	C14912 C14913 C14955 C14956 C15015	P14912 P14913 P14955 P14956 P15015	2	4		1
Testosterone	Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses	Transdermal	Testavan	IX	MP NP	C6324 C6910 C6919 C6933 C6934	P6324 P6910 P6919 P6933 P6934	1	5		1
Testosterone	Transdermal gel (pump pack) 23 mg per 1.15 g dose, 56 doses	Transdermal	Testavan	IX	MP NP	C14912 C14913 C14955 C14956 C15015	P14912 P14913 P14955 P14956 P15015	2	5		1
Tetrabenazine	Tablet 25 mg	Oral	iNova Pharmaceuticals (Australia) Pty Ltd	IL	MP NP	C16537	P16537	112	5		112
Tetrabenazine	Tablet 25 mg	Oral	iNova Pharmaceuticals (Australia) Pty Ltd	IL	MP NP	C16699	P16699	224	5		112
Tetrabenazine	Tablet 25 mg	Oral	Tetrabenazine SUN	RA	MP NP	C16537	P16537	112	5		112
Tetrabenazine	Tablet 25 mg	Oral	Tetrabenazine SUN	RA	MP NP	C16699	P16699	224	5		112
Tetracosactide	Compound depot injection 1 mg in 1 mL	Injection	Synacthen Depot 1 mg/1 mL	IX	MP	C7484		5	5		1
Tezacaftor with ivacaftor and ivacaftor	Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg	Oral	Symdeko	VR	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Tezepelumab	Solution for injection 210 mg in 1.91 mL single dose pre-filled pen (110 mg per mL)	Injection	Tezspire	AP	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Thalidomide	Capsule 50 mg	Oral	Thalomid	BQ	MP	C5914 C9290		112	0		28	D(100)
Thalidomide	Capsule 100 mg	Oral	Thalomid	BQ	MP	C5914 C9290		56	0		28	D(100)
Theophylline	Oral solution 133.3 mg per 25 mL, 500 mL	Oral	Nuelin	IL	MP NP			1	5		1
Theophylline	Tablet 200 mg (sustained release)	Oral	Nuelin-SR 200	IL	MP NP			100	5		100
Theophylline	Tablet 250 mg (sustained release)	Oral	Nuelin-SR 250	IL	MP NP			100	5		100
Theophylline	Tablet 300 mg (sustained release)	Oral	Nuelin-SR 300	IL	MP NP			100	5		100
Thiamine	Tablet containing thiamine hydrochloride 100 mg	Oral	Betavit	PP	MP NP	C5139	P5139	100	2		100
Thiamine	Tablet containing thiamine hydrochloride 100 mg	Oral	Betavit	PP	MP NP	C14319	P14319	200	2		100
Thyrotropin alfa	Powder for injection 0.9 mg, 2	Injection	Thyrogen	GZ	MP	C5296		1	0		1
Tiagabine	Tablet 5 mg (as hydrochloride)	Oral	Gabitril	TB	MP NP	C17445	P17445	100	5		50
Tiagabine	Tablet 5 mg (as hydrochloride)	Oral	Gabitril	TB	MP NP	C17444	P17444	200	5		50
Tiagabine	Tablet 10 mg (as hydrochloride)	Oral	Gabitril	TB	MP NP	C17445	P17445	100	5		50
Tiagabine	Tablet 10 mg (as hydrochloride)	Oral	Gabitril	TB	MP NP	C17444	P17444	200	5		50
Tiagabine	Tablet 15 mg (as hydrochloride)	Oral	Gabitril	TB	MP NP	C17445	P17445	100	5		50
Tiagabine	Tablet 15 mg (as hydrochloride)	Oral	Gabitril	TB	MP NP	C17444	P17444	200	5		50
Ticagrelor	Tablet 90 mg	Oral	ARX-TICAGRELOR	XT	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	ARX-TICAGRELOR	XT	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Brilinta	AP	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Brilinta	AP	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Pharmacor Ticagrelor	CR	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Pharmacor Ticagrelor	CR	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Dr.Reddy's	RZ	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Dr.Reddy's	RZ	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Lupin	GQ	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Lupin	GQ	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Sandoz	SZ	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Sandoz	SZ	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor SUN	RA	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor SUN	RA	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Viatris	AF	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Ticagrelor Viatris	AF	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	TICALOR	BZ	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	TICALOR	BZ	MP NP	C14240	P14240	112	5		56
Ticagrelor	Tablet 90 mg	Oral	Tirela	NB	MP NP	C5746	P5746	56	5		56
Ticagrelor	Tablet 90 mg	Oral	Tirela	NB	MP NP	C14240	P14240	112	5		56
Tildrakizumab	Injection 100 mg in 1 mL single dose pre-filled syringe	Injection	Ilumya	RA	MP	C18530 C18571 C18583	P18530 P18571 P18583	1	1		1
Tildrakizumab	Injection 100 mg in 1 mL single dose pre-filled syringe	Injection	Ilumya	RA	MP	C18614 C18680 C18681 C18682 C18704 C18705 C18717	P18614 P18680 P18681 P18682 P18704 P18705 P18717	1	2		1
Tildrakizumab	Injection 100 mg in 1 mL single dose pre-filled syringe	Injection	Ilumya	RA	MP	C19006 C19028 C19029	P19006 P19028 P19029	2	1		2
Timolol	Eye drops 5 mg (as maleate) per mL, 5 mL	Application to the eye	TIMOEYE	DZ	AO MP NP			1	5		1
Timolol	Eye drops 5 mg (as maleate) per mL, 5 mL	Application to the eye	TIMOEYE	DZ	AO MP NP		P14238	2	5		1
Timolol	Eye drops 5 mg (as maleate) per mL, 5 mL	Application to the eye	Timoptol	MF	AO MP NP			1	5		1
Timolol	Eye drops 5 mg (as maleate) per mL, 5 mL	Application to the eye	Timoptol	MF	AO MP NP		P14238	2	5		1
Timolol	Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL	Application to the eye	Timoptol XE	MF	AO MP NP			1	5		1
Timolol	Eye drops (gellan gum solution) 5 mg (as maleate) per mL, 2.5 mL	Application to the eye	Timoptol XE	MF	AO MP NP		P14238	2	5		1
Tioguanine	Tablet 40 mg	Oral	Lanvis	AS	MP			25	1		25
Tiotropium	Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)	Inhalation by mouth	Braltus	TB	MP NP	C6352	P6352	30	5		30
Tiotropium	Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)	Inhalation by mouth	Braltus	TB	MP NP	C15611	P15611	60	5		30
Tiotropium	Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)	Inhalation by mouth	Spiriva	BY	MP NP	C6352	P6352	30	5		30
Tiotropium	Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)	Inhalation by mouth	Spiriva	BY	MP NP	C15611	P15611	60	5		30
Tiotropium	Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)	Inhalation by mouth	Tiotropium Lupin	GQ	MP NP	C6352	P6352	30	5		30
Tiotropium	Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)	Inhalation by mouth	Tiotropium Lupin	GQ	MP NP	C15611	P15611	60	5		30
Tiotropium	Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations)	Inhalation by mouth	Spiriva Respimat	BY	MP NP	C5509 C8606 C12599		1	5		1
Tiotropium	Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations), pack of 2	Inhalation by mouth	Spiriva Respimat	BY	MP NP	C15566 C15753 C15754		1	5		1
Tiotropium with olodaterol	Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses	Inhalation by mouth	Spiolto Respimat	BY	MP NP	C7798		1	5		1
Tiotropium with olodaterol	Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses, pack of 2	Inhalation by mouth	Spiolto Respimat	BY	MP NP	C15691		1	5		1
Tirofiban	Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL	Injection	Aggrastat	AS	MP NP	C16063 C16123 C16147		1	2		1
Tirofiban	Solution concentrate for I.V. infusion 12.5 mg (as hydrochloride) in 50 mL	Injection	Tirofiban Juno	JU	MP NP	C16063 C16123 C16147		1	2		1
Tislelizumab	Solution concentrate for I.V. infusion 100 mg in 10 mL	Injection	Tevimbra	IE	MP	C16375		See Note 3	See Note 3		1	D(100)
Tobramycin	Capsule containing powder for oral inhalation 28 mg (for use in podhaler)	Inhalation by mouth	TOBI podhaler	GO	MP NP	C17397	P17397	224	0		224
Tobramycin	Capsule containing powder for oral inhalation 28 mg (for use in podhaler)	Inhalation by mouth	TOBI podhaler	GO	MP NP	C17405	P17405	224	2		224
Tobramycin	Capsule containing powder for oral inhalation 28 mg (for use in podhaler)	Inhalation by mouth	TOBI podhaler	GO	MP NP	C17328	P17328	448	2		224
Tobramycin	Injection 80 mg (as sulfate) in 2 mL (without preservative)	Injection	Pfizer Australia Pty Ltd	PF	MP NP	C5446 C5490 C5519		10	1		5
Tobramycin	Injection 80 mg in 2 mL	Injection	Tobramycin Viatris	AL	MP NP	C5446 C5490 C5519		10	1		5
Tobramycin	Injection 500 mg (as sulfate) in 5 mL (without preservative)	Injection	Tobra-Day	FF	MP NP	C5498		10	1		10
Tobramycin	Solution for inhalation 300 mg in 5 mL	Inhalation	Tobi	GO	MP NP	C17349	P17349	56	2		56
Tobramycin	Solution for inhalation 300 mg in 5 mL	Inhalation	Tobi	GO	MP NP	C17403	P17403	112	2		56
Tobramycin	Solution for inhalation 300 mg in 5 mL	Inhalation	TOBRAMYCIN SUN	RA	MP NP	C17349	P17349	56	2		56
Tobramycin	Solution for inhalation 300 mg in 5 mL	Inhalation	TOBRAMYCIN SUN	RA	MP NP	C17403	P17403	112	2		56
Tobramycin	Solution for inhalation 300 mg in 5 mL	Inhalation	TOBRAMYCIN WKT	XT	MP NP	C17349	P17349	56	2		56
Tobramycin	Solution for inhalation 300 mg in 5 mL	Inhalation	TOBRAMYCIN WKT	XT	MP NP	C17403	P17403	112	2		56
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Actemra	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Avtozma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Tocilizumab	Concentrate for injection 200 mg in 10 mL	Injection	Actemra	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Tocilizumab	Concentrate for injection 200 mg in 10 mL	Injection	Avtozma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Tocilizumab	Concentrate for injection 400 mg in 20 mL	Injection	Actemra	RO	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Tocilizumab	Concentrate for injection 400 mg in 20 mL	Injection	Avtozma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPen	RO	MP	C10560	P10560	4	0		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPen	RO	MP	C9477 C14094 C14121 C14182 C17709 C17748 C17760 C18639	P9477 P14094 P14121 P14182 P17709 P17748 P17760 P18639	4	1		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPen	RO	MP	C14084 C17710 C17742	P14084 P17710 P17742	4	2		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPen	RO	MP	C14080 C14147 C14175 C18534 C18562 C18565 C18584 C18601 C18604 C18638 C18661 C18670 C18696	P14080 P14147 P14175 P18534 P18562 P18565 P18584 P18601 P18604 P18638 P18661 P18670 P18696	4	3		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPen	RO	MP	C14088 C14499 C14507 C16725 C18944 C18945 C18947 C19268	P14088 P14499 P14507 P16725 P18944 P18945 P18947 P19268	4	5		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Actemra ACTPen	RO	MP	C9180	P9180	4	6		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Avtozma	EW	MP	C10560	P10560	4	0		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Avtozma	EW	MP	C9477 C14094 C14121 C14182 C17709 C17748 C17760 C18639 C19002	P9477 P14094 P14121 P14182 P17709 P17748 P17760 P18639 P19002	4	1		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Avtozma	EW	MP	C14084 C17710 C17742	P14084 P17710 P17742	4	2		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Avtozma	EW	MP	C14080 C14147 C14175 C18534 C18562 C18565 C18584 C18601 C18604 C18638 C18661 C18670 C18696 C18948 C19004 C19027 C19041	P14080 P14147 P14175 P18534 P18562 P18565 P18584 P18601 P18604 P18638 P18661 P18670 P18696 P18948 P19004 P19027 P19041	4	3		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Avtozma	EW	MP	C14088 C14499 C14507 C16725 C18938 C18939 C18944 C18945 C18947 C19036 C19268	P14088 P14499 P14507 P16725 P18938 P18939 P18944 P18945 P18947 P19036 P19268	4	5		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled pen	Injection	Avtozma	EW	MP	C9180 C19020	P9180 P19020	4	6		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous Injection	RO	MP	C10560	P10560	4	0		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous Injection	RO	MP	C9477 C14094 C14121 C14182 C17709 C17748 C17760 C18639	P9477 P14094 P14121 P14182 P17709 P17748 P17760 P18639	4	1		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous Injection	RO	MP	C14084 C17710 C17742	P14084 P17710 P17742	4	2		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous Injection	RO	MP	C14080 C14147 C14175 C18534 C18562 C18565 C18584 C18601 C18604 C18638 C18661 C18670 C18696	P14080 P14147 P14175 P18534 P18562 P18565 P18584 P18601 P18604 P18638 P18661 P18670 P18696	4	3		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous Injection	RO	MP	C14088 C14499 C14507 C16725 C18944 C18945 C18947 C19268	P14088 P14499 P14507 P16725 P18944 P18945 P18947 P19268	4	5		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Actemra Subcutaneous Injection	RO	MP	C9180	P9180	4	6		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Avtozma	EW	MP	C10560	P10560	4	0		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Avtozma	EW	MP	C9477 C14094 C14121 C14182 C17709 C17748 C17760 C18639 C19002	P9477 P14094 P14121 P14182 P17709 P17748 P17760 P18639 P19002	4	1		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Avtozma	EW	MP	C14084 C17710 C17742	P14084 P17710 P17742	4	2		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Avtozma	EW	MP	C14080 C14147 C14175 C18534 C18562 C18565 C18584 C18601 C18604 C18638 C18661 C18670 C18696 C18948 C19004 C19027 C19041	P14080 P14147 P14175 P18534 P18562 P18565 P18584 P18601 P18604 P18638 P18661 P18670 P18696 P18948 P19004 P19027 P19041	4	3		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Avtozma	EW	MP	C14088 C14499 C14507 C16725 C18938 C18939 C18944 C18945 C18947 C19036 C19268	P14088 P14499 P14507 P16725 P18938 P18939 P18944 P18945 P18947 P19036 P19268	4	5		4
Tocilizumab	Injection 162 mg in 0.9 mL single use pre-filled syringe	Injection	Avtozma	EW	MP	C9180 C19020	P9180 P19020	4	6		4
Tofacitinib	Oral solution 1 mg per mL, 240 mL	Oral	Xeljanz	PF	MP	C12120 C17737 C17745 C17746	P12120 P17737 P17745 P17746	1	3		1
Tofacitinib	Oral solution 1 mg per mL, 240 mL	Oral	Xeljanz	PF	MP	C17707	P17707	1	5		1
Tofacitinib	Tablet 5 mg	Oral	Xeljanz	PF	MP	C9064 C11915 C11940 C11944 C11956 C11975 C11976 C12120 C12174 C14655 C14662 C14670 C16392 C17737 C17745 C17746 C18534 C18562 C18584 C18604	P9064 P11915 P11940 P11944 P11956 P11975 P11976 P12120 P12174 P14655 P14662 P14670 P16392 P17737 P17745 P17746 P18534 P18562 P18584 P18604	56	3		56
Tofacitinib	Tablet 5 mg	Oral	Xeljanz	PF	MP	C9431 C11883 C11886 C11978 C12976 C14499 C14507 C14692 C16725 C17707	P9431 P11883 P11886 P11978 P12976 P14499 P14507 P14692 P16725 P17707	56	5		56
Tofacitinib	Tablet 10 mg	Oral	Xeljanz	PF	MP	C11915 C11940 C11975 C11976	P11915 P11940 P11975 P11976	56	3		56
Tofacitinib	Tablet 10 mg	Oral	Xeljanz	PF	MP	C11883 C12976	P11883 P12976	56	5		56
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody	BD	MP	C19261	P19261	1	2		1	D(100)
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody	BD	MP	C19237 C19253	P19237 P19253	1	5		1	D(100)
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody	BD	MP	C19231 C19243	P19231 P19243	1	6		1	D(100)
Tolvaptan	Pack containing 28 tablets 15 mg and 28 tablets 45 mg	Oral	Jinarc	OS	MP	C8288 C10250		1	5		1
Tolvaptan	Pack containing 28 tablets 15 mg and 28 tablets 45 mg	Oral	Tolvaptan Lupin	GQ	MP	C8288 C10250		1	5		1
Tolvaptan	Pack containing 28 tablets 30 mg and 28 tablets 60 mg	Oral	Jinarc	OS	MP	C8288 C10250		1	5		1
Tolvaptan	Pack containing 28 tablets 30 mg and 28 tablets 60 mg	Oral	Tolvaptan Lupin	GQ	MP	C8288 C10250		1	5		1
Tolvaptan	Pack containing 28 tablets 30 mg and 28 tablets 90 mg	Oral	Jinarc	OS	MP	C8288 C10250		1	5		1
Tolvaptan	Pack containing 28 tablets 30 mg and 28 tablets 90 mg	Oral	Tolvaptan Lupin	GQ	MP	C8288 C10250		1	5		1
Tolvaptan	Tablet 15 mg	Oral	Jinarc	OS	MP	C8288 C10250		28	5		28
Tolvaptan	Tablet 30 mg	Oral	Jinarc	OS	MP	C8288 C10250		28	5		28
Topiramate	Capsule 15 mg	Oral	Topamax Sprinkle	JC	MP NP	C17488	P17488	60	5		60
Topiramate	Capsule 15 mg	Oral	Topamax Sprinkle	JC	MP NP	C17525	P17525	120	5		60
Topiramate	Capsule 25 mg	Oral	Topamax Sprinkle	JC	MP NP	C17488	P17488	60	5		60
Topiramate	Capsule 25 mg	Oral	Topamax Sprinkle	JC	MP NP	C17525	P17525	120	5		60
Topiramate	Capsule 50 mg	Oral	Topamax Sprinkle	JC	MP NP	C17488	P17488	60	5		60
Topiramate	Capsule 50 mg	Oral	Topamax Sprinkle	JC	MP NP	C17525	P17525	120	5		60
Topiramate	Tablet 25 mg	Oral	APO-Topiramate	TX	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 25 mg	Oral	APO-Topiramate	TX	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 25 mg	Oral	Epiramax 25	RW	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 25 mg	Oral	Epiramax 25	RW	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 25 mg	Oral	RBX Topiramate	RA	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 25 mg	Oral	RBX Topiramate	RA	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 25 mg	Oral	Tamate	AF	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 25 mg	Oral	Tamate	AF	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 25 mg	Oral	Topiramate Sandoz	SZ	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 25 mg	Oral	Topiramate Sandoz	SZ	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 25 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 25 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 50 mg	Oral	APO-Topiramate	TX	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 50 mg	Oral	APO-Topiramate	TX	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 50 mg	Oral	Epiramax 50	RW	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 50 mg	Oral	Epiramax 50	RW	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 50 mg	Oral	RBX Topiramate	RA	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 50 mg	Oral	RBX Topiramate	RA	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 50 mg	Oral	Tamate	AF	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 50 mg	Oral	Tamate	AF	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 50 mg	Oral	Topiramate Sandoz	SZ	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 50 mg	Oral	Topiramate Sandoz	SZ	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 50 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 50 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 100 mg	Oral	APO-Topiramate	TX	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 100 mg	Oral	APO-Topiramate	TX	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 100 mg	Oral	Epiramax 100	RW	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 100 mg	Oral	Epiramax 100	RW	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 100 mg	Oral	RBX Topiramate	RA	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 100 mg	Oral	RBX Topiramate	RA	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 100 mg	Oral	Tamate	AF	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 100 mg	Oral	Tamate	AF	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 100 mg	Oral	Topiramate Sandoz	SZ	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 100 mg	Oral	Topiramate Sandoz	SZ	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 100 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C5325 C17487	P5325 P17487	60	5		60
Topiramate	Tablet 100 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C14901 C17562	P14901 P17562	120	5		60
Topiramate	Tablet 200 mg	Oral	APO-Topiramate	TX	MP NP	C17487	P17487	60	5		60
Topiramate	Tablet 200 mg	Oral	APO-Topiramate	TX	MP NP	C17562	P17562	120	5		60
Topiramate	Tablet 200 mg	Oral	Epiramax 200	RW	MP NP	C17487	P17487	60	5		60
Topiramate	Tablet 200 mg	Oral	Epiramax 200	RW	MP NP	C17562	P17562	120	5		60
Topiramate	Tablet 200 mg	Oral	RBX Topiramate	RA	MP NP	C17487	P17487	60	5		60
Topiramate	Tablet 200 mg	Oral	RBX Topiramate	RA	MP NP	C17562	P17562	120	5		60
Topiramate	Tablet 200 mg	Oral	Tamate	AF	MP NP	C17487	P17487	60	5		60
Topiramate	Tablet 200 mg	Oral	Tamate	AF	MP NP	C17562	P17562	120	5		60
Topiramate	Tablet 200 mg	Oral	Topiramate Sandoz	SZ	MP NP	C17487	P17487	60	5		60
Topiramate	Tablet 200 mg	Oral	Topiramate Sandoz	SZ	MP NP	C17562	P17562	120	5		60
Topiramate	Tablet 200 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C17487	P17487	60	5		60
Topiramate	Tablet 200 mg	Oral	TOPIRAMATE-WGR	WG	MP NP	C17562	P17562	120	5		60
Topotecan	Powder for I.V. infusion 4 mg (as hydrochloride)	Injection	Hycamtin	SZ	MP			See Note 3	See Note 3		5	D(100)
Topotecan	Solution concentrate for I.V. infusion 4 mg in 4 mL (as hydrochloride)	Injection	Topotecan Accord	OC	MP			See Note 3	See Note 3		5	D(100)
Toripalimab	Solution concentrate for I.V. infusion 240 mg in 6 mL	Injection	Zytorvi	RZ	MP	C17616		See Note 3	See Note 3	V17616	1	D(100)
Trabectedin	Powder for I.V. infusion 1 mg	Injection	Yondelis	ZL	MP	C14196 C14197		See Note 3	See Note 3		1	D(100)
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	APO-Tramadol	TX	MP NP MW	C16276	P16276	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	APO-Tramadol	TX	PDP	C10766	P10766	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	APO-Tramadol	TX	PDP	C10768	P10768	20	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	APO-Tramadol	TX	MP NP	C10764 C10771 C10772	P10764 P10771 P10772	20	0	V10764 V10771 V10772	20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramadol Sandoz	SZ	MP NP MW	C16276	P16276	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramadol Sandoz	SZ	PDP	C10766	P10766	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramadol Sandoz	SZ	PDP	C10768	P10768	20	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramadol Sandoz	SZ	MP NP	C10764 C10771 C10772	P10764 P10771 P10772	20	0	V10764 V10771 V10772	20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	TRAMADOL-WGR	WG	MP NP MW	C16276	P16276	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	TRAMADOL-WGR	WG	PDP	C10766	P10766	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	TRAMADOL-WGR	WG	PDP	C10768	P10768	20	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	TRAMADOL-WGR	WG	MP NP	C10764 C10771 C10772	P10764 P10771 P10772	20	0	V10764 V10771 V10772	20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramal	CS	MP NP MW	C16276	P16276	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramal	CS	PDP	C10766	P10766	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramal	CS	PDP	C10768	P10768	20	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramal	CS	MP NP	C10764 C10771 C10772	P10764 P10771 P10772	20	0	V10764 V10771 V10772	20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramedo	AF	MP NP MW	C16276	P16276	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramedo	AF	PDP	C10766	P10766	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramedo	AF	PDP	C10768	P10768	20	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Tramedo	AF	MP NP	C10764 C10771 C10772	P10764 P10771 P10772	20	0	V10764 V10771 V10772	20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Zydol	RW	MP NP MW	C16276	P16276	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Zydol	RW	PDP	C10766	P10766	10	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Zydol	RW	PDP	C10768	P10768	20	0		20
Tramadol	Capsule containing tramadol hydrochloride 50 mg	Oral	Zydol	RW	MP NP	C10764 C10771 C10772	P10764 P10771 P10772	20	0	V10764 V10771 V10772	20
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol AN	JU	MP NP	C10764 C10771 C10772		5	0	V10764 V10771 V10772	5
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol AN	JU	PDP	C10768		5	0		5
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol Sandoz	SZ	MP NP	C10764 C10771 C10772		5	0	V10764 V10771 V10772	5
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramadol Sandoz	SZ	PDP	C10768		5	0		5
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramal 100	CS	MP NP	C10764 C10771 C10772		5	0	V10764 V10771 V10772	5
Tramadol	Injection containing tramadol hydrochloride 100 mg in 2 mL	Injection	Tramal 100	CS	PDP	C10768		5	0		5
Tramadol	Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL	Oral	Tramal	CS	PDP	C10768		1	0		1
Tramadol	Oral drops containing tramadol hydrochloride 100 mg per mL, 10 mL	Oral	Tramal	CS	MP NP	C10764 C10771 C10772		1	0	V10764 V10771 V10772	1
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 50 mg	Oral	Tramal SR 50	CS	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	APO-Tramadol SR	TX	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	Tramadol Sandoz SR	SZ	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	Tramadol SR generichealth	GQ	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	TRAMADOL-WGR SR	WG	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	Tramal SR 100	CS	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	Tramedo SR	AL	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 100 mg	Oral	Zydol SR 100	RW	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	APO-Tramadol SR	TX	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	Tramadol Sandoz SR	SZ	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	Tramadol SR generichealth	GQ	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	TRAMADOL-WGR SR	WG	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	Tramal SR 150	CS	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	Tramedo SR	AL	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 150 mg	Oral	Zydol SR 150	RW	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	APO-Tramadol SR	TX	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	Tramadol Sandoz SR	SZ	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	Tramadol SR generichealth	GQ	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	TRAMADOL-WGR SR	WG	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	Tramal SR 200	CS	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	Tramedo SR	AL	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Tramadol	Tablet (sustained release) containing tramadol hydrochloride 200 mg	Oral	Zydol SR 200	RW	MP NP	C10748 C10752 C10755		20	0	V10748 V10752 V10755	20
Trametinib	Powder for oral solution 50 micrograms per mL (as dimethylsulfoxide), 90 mL	Oral	Mekinist	NV	MP	C16371 C16372		13	3		1
Trametinib	Tablet 500 micrograms	Oral	Mekinist	NV	MP NP	C17915 C17950	P17915 P17950	90	3		30
Trametinib	Tablet 500 micrograms	Oral	Mekinist	NV	MP	C10051	P10051	90	3		30
Trametinib	Tablet 500 micrograms	Oral	Mekinist	NV	MP NP	C17951	P17951	90	5		30
Trametinib	Tablet 500 micrograms	Oral	Mekinist	NV	MP	C17286	P17286	90	5		30
Trametinib	Tablet 500 micrograms	Oral	Mekinist	NV	MP	C16371 C16372	P16371 P16372	120	3		30
Trametinib	Tablet 2 mg	Oral	Mekinist	NV	MP NP	C17915 C17950	P17915 P17950	30	3		30
Trametinib	Tablet 2 mg	Oral	Mekinist	NV	MP	C10051 C16371 C16372	P10051 P16371 P16372	30	3		30
Trametinib	Tablet 2 mg	Oral	Mekinist	NV	MP NP	C17951	P17951	30	5		30
Trametinib	Tablet 2 mg	Oral	Mekinist	NV	MP	C17286	P17286	30	5		30
Trandolapril	Capsule 500 micrograms	Oral	Dolapril 0.5	RW	MP NP			28	5		28
Trandolapril	Capsule 500 micrograms	Oral	Dolapril 0.5	RW	MP NP		P14238	56	5		28
Trandolapril	Capsule 500 micrograms	Oral	Gopten	GO	MP NP			28	5		28
Trandolapril	Capsule 500 micrograms	Oral	Gopten	GO	MP NP		P14238	56	5		28
Trandolapril	Capsule 500 micrograms	Oral	Tranalpha	AF	MP NP			28	5		28
Trandolapril	Capsule 500 micrograms	Oral	Tranalpha	AF	MP NP		P14238	56	5		28
Trandolapril	Capsule 500 micrograms	Oral	Trandolapril Viatris	AL	MP NP			28	5		28
Trandolapril	Capsule 500 micrograms	Oral	Trandolapril Viatris	AL	MP NP		P14238	56	5		28
Trandolapril	Capsule 1 mg	Oral	Dolapril 1	RW	MP NP			28	5		28
Trandolapril	Capsule 1 mg	Oral	Dolapril 1	RW	MP NP		P14238	56	5		28
Trandolapril	Capsule 1 mg	Oral	Gopten	GO	MP NP			28	5		28
Trandolapril	Capsule 1 mg	Oral	Gopten	GO	MP NP		P14238	56	5		28
Trandolapril	Capsule 1 mg	Oral	Tranalpha	AF	MP NP			28	5		28
Trandolapril	Capsule 1 mg	Oral	Tranalpha	AF	MP NP		P14238	56	5		28
Trandolapril	Capsule 1 mg	Oral	Trandolapril Viatris	AL	MP NP			28	5		28
Trandolapril	Capsule 1 mg	Oral	Trandolapril Viatris	AL	MP NP		P14238	56	5		28
Trandolapril	Capsule 2 mg	Oral	Dolapril 2	RW	MP NP			28	5		28
Trandolapril	Capsule 2 mg	Oral	Dolapril 2	RW	MP NP		P14238	56	5		28
Trandolapril	Capsule 2 mg	Oral	Gopten	GO	MP NP			28	5		28
Trandolapril	Capsule 2 mg	Oral	Gopten	GO	MP NP		P14238	56	5		28
Trandolapril	Capsule 2 mg	Oral	Tranalpha	AF	MP NP			28	5		28
Trandolapril	Capsule 2 mg	Oral	Tranalpha	AF	MP NP		P14238	56	5		28
Trandolapril	Capsule 2 mg	Oral	Trandolapril Viatris	AL	MP NP			28	5		28
Trandolapril	Capsule 2 mg	Oral	Trandolapril Viatris	AL	MP NP		P14238	56	5		28
Trandolapril	Capsule 4 mg	Oral	Dolapril 4	RW	MP NP			28	5		28
Trandolapril	Capsule 4 mg	Oral	Dolapril 4	RW	MP NP		P14238	56	5		28
Trandolapril	Capsule 4 mg	Oral	Gopten	GO	MP NP			28	5		28
Trandolapril	Capsule 4 mg	Oral	Gopten	GO	MP NP		P14238	56	5		28
Trandolapril	Capsule 4 mg	Oral	Tranalpha	AF	MP NP			28	5		28
Trandolapril	Capsule 4 mg	Oral	Tranalpha	AF	MP NP		P14238	56	5		28
Trandolapril	Capsule 4 mg	Oral	Trandolapril Viatris	AL	MP NP			28	5		28
Trandolapril	Capsule 4 mg	Oral	Trandolapril Viatris	AL	MP NP		P14238	56	5		28
Trandolapril with verapamil	Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release)	Oral	Tarka 2/180	GO	MP NP			28	5		28
Trandolapril with verapamil	Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release)	Oral	Tarka 2/180	GO	MP NP		P14238	56	5		28
Trandolapril with verapamil	Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)	Oral	Tarka 4/240	GO	MP NP			28	5		28
Trandolapril with verapamil	Tablet containing trandolapril 4 mg with verapamil hydrochloride 240 mg (sustained release)	Oral	Tarka 4/240	GO	MP NP		P14238	56	5		28
Tranexamic acid	Tablet 500 mg	Oral	APO-Tranexamic Acid	TX	MP NP			100	2		100
Tranexamic acid	Tablet 500 mg	Oral	Cyklokapron	PF	MP NP			100	2		100
Tranexamic acid	Tablet 500 mg	Oral	Tranexamic Acid Lupin	GQ	MP NP			100	2		100
Tranexamic acid	Tablet 500 mg	Oral	Tranexamic Acid Waymade	IX	MP NP			100	2		100
Tranylcypromine	Tablet 10 mg (as sulfate)	Oral	Parnate	GH	MP			50	2		50
Tranylcypromine	Tablet 10 mg (as sulfate)	Oral	Parnate	GH	MP		P14238	100	1		50
Tranylcypromine	Tablet 10 mg (as sulfate)	Oral	TRANYLMED	DZ	MP			50	2		50
Tranylcypromine	Tablet 10 mg (as sulfate)	Oral	TRANYLMED	DZ	MP		P14238	100	1		50
Trastuzumab	Powder for I.V. infusion 60 mg	Injection	Trazimera	PF	MP	C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831		See Note 3	See Note 3	V15820 V15831	1	PB(100)
Trastuzumab	Powder for I.V. infusion 150 mg	Injection	Herzuma	EW	MP	C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831		See Note 3	See Note 3	V15820 V15831	1	PB(100)
Trastuzumab	Powder for I.V. infusion 150 mg	Injection	Ogivri	SZ	MP	C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831		See Note 3	See Note 3	V15820 V15831	1	PB(100)
Trastuzumab	Powder for I.V. infusion 150 mg	Injection	Trazimera	PF	MP	C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831		See Note 3	See Note 3	V15820 V15831	1	PB(100)
Trastuzumab	Powder for I.V. infusion 420 mg	Injection	Kanjinti	XT	MP	C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831		See Note 3	See Note 3	V15820 V15831	1	PB(100)
Trastuzumab	Powder for I.V. infusion 440 mg with diluent	Injection	Herzuma	EW	MP	C9349 C9353 C9571 C9573 C10213 C10294 C15820 C15831		See Note 3	See Note 3	V15820 V15831	1	PB(100)
Trastuzumab	Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL	Injection	Herceptin SC	RO	MP	C9353	P9353	1	0		1
Trastuzumab	Solution for subcutaneous injection containing trastuzumab 600 mg in 5 mL	Injection	Herceptin SC	RO	MP	C9462 C10212	P9462 P10212	1	3		1
Trastuzumab deruxtecan	Powder for I.V. infusion 100 mg	Injection	Enhertu	AP	MP	C15826 C15832		See Note 3	See Note 3	V15826 V15832	1	D(100)
Trastuzumab emtansine	Powder for I.V. infusion 100 mg	Injection	Kadcyla	RO	MP	C15818 C15819 C15827 C15828		See Note 3	See Note 3	V15818 V15819 V15827 V15828	1	D(100)
Trastuzumab emtansine	Powder for I.V. infusion 160 mg	Injection	Kadcyla	RO	MP	C15818 C15819 C15827 C15828		See Note 3	See Note 3	V15818 V15819 V15827 V15828	1	D(100)
Travoprost	Eye drops 40 micrograms per mL, 2.5 mL	Application to the eye	Travatan	NV	AO MP NP			1	5		1
Travoprost	Eye drops 40 micrograms per mL, 2.5 mL	Application to the eye	Travatan	NV	AO MP NP		P14238	2	5		1
Travoprost with timolol	Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL	Application to the eye	Duotrav	NV	AO	C5038	P5038	1	5		1
Travoprost with timolol	Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL	Application to the eye	Duotrav	NV	MP NP	C4343	P4343	1	5		1
Travoprost with timolol	Eye drops 40 micrograms travoprost with timolol 5 mg (as maleate) per mL, 2.5 mL	Application to the eye	Duotrav	NV	AO MP NP	C15558	P15558	2	5		1
Tremelimumab	Solution concentrate for I.V. infusion 300 mg in 15 mL	Injection	Imjudo	AP	MP	C17477		See Note 3	See Note 3		1	D(100)
Triamcinolone	Cream containing triamcinolone acetonide 200 micrograms per g, 100 g	Application	Aristocort 0.02%	AS	MP NP	C4924		2	0		1
Triamcinolone	Cream containing triamcinolone acetonide 200 micrograms per g, 100 g	Application	Tricortone	LN	MP NP	C4924		2	0		1
Triamcinolone	Injection containing triamcinolone acetonide 10 mg in 1 mL	Injection	Kenacort-A10	AS	MP NP	C6210 C6211 C6253 C6254 C6255 C6268 C6269 C6281 C6287		5	0		5
Triamcinolone	Injection containing triamcinolone acetonide 10 mg in 1 mL	Injection	Kenacort-A10	AS	PDP	C6209 C6237 C6291		5	0		5
Triamcinolone	Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g	Application	Aristocort 0.02%	AS	MP NP	C4924		2	0		1
Triamcinolone	Ointment containing triamcinolone acetonide 200 micrograms per g, 100 g	Application	Tricortone	LN	MP NP	C4924		2	0		1
Triamcinolone with neomycin, gramicidin and nystatin	Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL	Application to the ear	Kenacomb Otic	AS	MP NP			1	2		1
Triamcinolone with neomycin, gramicidin and nystatin	Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL	Application to the ear	Otocomb Otic	LN	MP NP			1	2		1
Triamcinolone with neomycin, gramicidin and nystatin	Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g	Application to the ear	Kenacomb Otic	AS	MP NP			1	2		1
Triamcinolone with neomycin, gramicidin and nystatin	Ear ointment containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 5 g	Application to the ear	Otocomb Otic	LN	MP NP			1	2		1
Trientine	Capsule containing trientine dihydrochloride 250 mg (equivalent to 166.7 mg trientine)	Oral	Trientine Dr. Reddy's	RZ	MP NP	C13321		200	5		100
Trientine	Capsule containing trientine dihydrochloride 250 mg (equivalent to 166.7 mg trientine)	Oral	Trientine Waymade	IX	MP NP	C13321		200	5		100
Trifluridine with tipiracil	Tablet containing 15 mg trifluridine with 6.14 mg tipiracil (as hydrochloride)	Oral	Lonsurf 15/6.14	SE	MP	C8183 C10310 C18515 C18518		60	2		20
Trifluridine with tipiracil	Tablet containing 20 mg trifluridine with 8.19 mg tipiracil (as hydrochloride)	Oral	Lonsurf 20/8.19	SE	MP	C8183 C10310 C18515 C18518		80	2		20
Triglycerides - medium chain, formula	Oral liquid 500 mL, 12 (Nutrini Peptisorb)	Oral	Nutrini Peptisorb	SB	MP NP	C4660		12	5		1
Triglycerides - medium chain, formula	Oral powder 400 g (Lipistart)	Oral	Lipistart	VF	MP NP	C4651 C4652 C4653 C4659 C4660		8	5		1
Triglycerides - medium chain, formula	Oral powder 400 g (Monogen)	Oral	Monogen	SB	MP NP	C4651 C4652 C4653 C4659 C4660		8	5		1
Triglycerides - medium chain, formula	Oral powder 400 g (Peptamen Junior)	Oral	Peptamen Junior	NT	MP NP	C4660		8	5		1
Triglycerides, long chain with glucose polymer	Oral liquid 1 L, 6 (ProZero)	Oral	ProZero	VF	MP NP	C4438		4	5		1
Triglycerides, medium chain	Oil 500 mL (MCT Oil)	Oral	MCT Oil	SB	MP NP	C6134 C6135 C6146 C6155 C6164 C6181 C6203		2	5		1
Triglycerides, medium chain	Oral emulsion 250 mL (Liquigen)	Oral	Liquigen	SB	MP NP	C6134 C6135 C6146 C6155 C6164 C6181 C6203		8	5		1
Triglycerides, medium chain and long chain with glucose polymer	Oral powder 400 g (Duocal)	Oral	Duocal	SB	MP NP	C4438		8	5		1
Trihexyphenidyl	Tablet containing trihexyphenidyl hydrochloride 2 mg	Oral	Artane	RW	MP NP			200	2		200
Trihexyphenidyl	Tablet containing trihexyphenidyl hydrochloride 5 mg	Oral	Artane	RW	MP NP			200	1		200
Trimethoprim	Tablet 300 mg	Oral	Alprim	AF	MP NP MW			7	1		7
Trimethoprim	Tablet 300 mg	Oral	Alprim	AF	MP		P4243	14CN4243	2CN4243		7
Trimethoprim	Tablet 300 mg	Oral	Alprim	AF	MP		P6163	28	0		7
Trimethoprim	Tablet 300 mg	Oral	Trimethoprim Viatris	MQ	MP NP MW			7	1		7
Trimethoprim	Tablet 300 mg	Oral	Trimethoprim Viatris	MQ	MP		P4243	14CN4243	2CN4243		7
Trimethoprim	Tablet 300 mg	Oral	Trimethoprim Viatris	MQ	MP		P6163	28	0		7
Trimethoprim	Tablet 300 mg	Oral	TRIMETHOPRIM-WGR	WG	MP NP MW			7	1		7
Trimethoprim	Tablet 300 mg	Oral	TRIMETHOPRIM-WGR	WG	MP		P4243	14CN4243	2CN4243		7
Trimethoprim	Tablet 300 mg	Oral	TRIMETHOPRIM-WGR	WG	MP		P6163	28	0		7
Trimethoprim	Tablet 300 mg	Oral	Triprim	RW	MP NP MW			7	1		7
Trimethoprim	Tablet 300 mg	Oral	Triprim	RW	MP		P4243	14CN4243	2CN4243		7
Trimethoprim	Tablet 300 mg	Oral	Triprim	RW	MP		P6163	28	0		7
Trimethoprim with sulfamethoxazole	Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL	Oral	Septrin	RW	PDP			1	0		1
Trimethoprim with sulfamethoxazole	Paediatric oral suspension 40 mg-200 mg per 5 mL, 100 mL	Oral	Septrin	RW	MP NP			1	1		1
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Bactrim DS	XO	PDP			10	0		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Bactrim DS	XO	MP NP			10	1		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Bactrim DS	XO	MP NP		P6201	30CN6201	2CN6201		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Resprim Forte	AF	PDP			10	0		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Resprim Forte	AF	MP NP			10	1		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Resprim Forte	AF	MP NP		P6201	30CN6201	2CN6201		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Septrin Forte	RW	PDP			10	0		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Septrin Forte	RW	MP NP			10	1		10
Trimethoprim with sulfamethoxazole	Tablet 160 mg-800 mg	Oral	Septrin Forte	RW	MP NP		P6201	30CN6201	2CN6201		10
Triptorelin	Injection 100 micrograms (as acetate) in 1 mL pre-filled syringe	Injection	Decapeptyl	FP	MP	C5046		28	0		7	PB(100)
Triptorelin	Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles	Injection	Diphereline	IS	MP NP			1	5		1
Triptorelin	Powder for I.M. injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles	Injection	Diphereline	IS	MP NP	C17812		1	1		1
Triptorelin	Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles	Injection	Diphereline	IS	MP NP	C12351 C12387 C17812		1	0		1
Tyrosine with carbohydrate	Sachets of oral powder 4 g containing 1 g tyrosine, 30 (Tyrosine 1000)	Oral	Tyrosine 1000	VF	MP NP	C4295		4	5		1
Ublituximab	Solution concentrate for I.V. infusion 150 mg in 6 mL	Injection	Briumvi	FW	MP	C7386 C9635	P7386 P9635	3	0		1	D(100)
Ublituximab	Solution concentrate for I.V. infusion 150 mg in 6 mL	Injection	Briumvi	FW	MP	C7699 C9523	P7699 P9523	4	0		1	D(100)
Umeclidinium	Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses	Inhalation by mouth	Incruse Ellipta	GK	MP NP	C4516	P4516	1	5		1
Umeclidinium	Powder for oral inhalation in breath actuated device 62.5 micrograms (as bromide) per dose, 30 doses	Inhalation by mouth	Incruse Ellipta	GK	MP NP	C15634	P15634	2	5		1
Umeclidinium with vilanterol	Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses	Inhalation by mouth	Anoro Ellipta 62.5/25	GK	MP NP	C7798	P7798	1	5		1
Umeclidinium with vilanterol	Powder for oral inhalation in breath actuated device containing umeclidinium 62.5 micrograms (as bromide) with vilanterol 25 micrograms (as trifenatate) per dose, 30 doses	Inhalation by mouth	Anoro Ellipta 62.5/25	GK	MP NP	C15691	P15691	2	5		1
Upadacitinib	Tablet 15 mg	Oral	Rinvoq	VE	MP	C13959	P13959	28	1		28
Upadacitinib	Tablet 15 mg	Oral	Rinvoq	VE	MP	C9064 C11944 C11956 C12174 C12504 C14217C14655 C14662 C14670 C15149 C15150 C16392 C18249 C18534 C18562 C18584 C18604	P9064 P11944 P11956 P12174 P12504 P14217 P14655 P14662 P14670 P15149 P15150 P16392 P18249 P18534 P18562 P18584 P18604	28	3		28
Upadacitinib	Tablet 15 mg	Oral	Rinvoq	VE	MP	C12499 C12508	P12499 P12508	28	4		28
Upadacitinib	Tablet 15 mg	Oral	Rinvoq	VE	MP	C9431 C10434 C11886 C11978 C12493 C12494 C13958 C14011 C14499 C14692 C15140 C18671 C18691 C18809 C18811 C18897	P9431 P10434 P11886 P11978 P12493 P12494 P13958 P14011 P14499 P14692 P15140 P18671 P18691 P18809 P18811 P18897	28	5		28
Upadacitinib	Tablet 30 mg	Oral	Rinvoq	VE	MP	C13959	P13959	28	1		28
Upadacitinib	Tablet 30 mg	Oral	Rinvoq	VE	MP	C18765 C18817 C18845 C18867 C18896	P18765 P18817 P18845 P18867 P18896	28	2		28
Upadacitinib	Tablet 30 mg	Oral	Rinvoq	VE	MP	C12504	P12504	28	3		28
Upadacitinib	Tablet 30 mg	Oral	Rinvoq	VE	MP	C12499 C12508	P12499 P12508	28	4		28
Upadacitinib	Tablet 30 mg	Oral	Rinvoq	VE	MP	C12493 C12494 C13958 C14011 C18809 C18810 C18897	P12493 P12494 P13958 P14011 P18809 P18810 P18897	28	5		28
Upadacitinib	Tablet 45 mg	Oral	Rinvoq	VE	MP	C18765 C18817 C18845 C18867	P18765 P18817 P18845 P18867	28	2		28
Upadacitinib	Tablet 45 mg	Oral	Rinvoq	VE	MP	C11976 C13990 C13999 C14014	P11976 P13990 P13999 P14014	28	3		28
Ursodeoxycholic acid	Capsule 250 mg	Oral	APO-Ursodeoxycholic acid	TX	MP NP	C16558		200	4		100
Ursodeoxycholic acid	Capsule 250 mg	Oral	Ursodox GH	GQ	MP NP	C16558		200	4		100
Ursodeoxycholic acid	Capsule 250 mg	Oral	Ursofalk	FD	MP NP	C16558		200	4		100
Ursodeoxycholic acid	Capsule 250 mg	Oral	Ursosan	BZ	MP NP	C16558		200	4		100
Ursodeoxycholic acid	Capsule 500 mg	Oral	Ursodox GH	GQ	MP NP	C16558		100	4		100
Ursodeoxycholic acid	Tablet 500 mg	Oral	ARX-URSODEOXYCHOLIC ACID	XT	MP NP	C16558		100	4		100
Ursodeoxycholic acid	Tablet 500 mg	Oral	Ursofalk	FD	MP NP	C16558		100	4		100
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C16818	P16818	1	0		1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C12156 C16836 C16856 C16896 C16924 C16925 C16927 C16976 C17000 C17094 C18723 C18898	P12156 P16836 P16856 P16896 P16924 P16925 P16927 P16976 P17000 P17094 P18723 P18898	1	1		1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C11120 C12334 C16832 C16868 C16885 C16894 C16899 C16900 C16910 C16920 C16922 C16937 C17039 C17067 C17068 C17070 C17071	P11120 P12334 P16832 P16868 P16885 P16894 P16899 P16900 P16910 P16920 P16922 P16937 P17039 P17067 P17068 P17070 P17071	1	2		1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Stelara	JC	MP	C18785 C18825 C18826 C18827 C18856 C18885	P18785 P18825 P18826 P18827 P18856 P18885	2	0	V18826 V18885	1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Wezlana	TN	MP	C16818	P16818	1	0		1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Wezlana	TN	MP	C12156 C16835 C16836 C16854 C16856 C16886 C16896 C16911 C16924 C16925 C16927 C16967 C16976 C17000 C17094 C18723 C18898	P12156 P16835 P16836 P16854 P16856 P16886 P16896 P16911 P16924 P16925 P16927 P16967 P16976 P17000 P17094 P18723 P18898	1	1		1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Wezlana	TN	MP	C11120 C12334 C16832 C16868 C16885 C16894 C16899 C16900 C16910 C16920 C16922 C16937 C17039 C17067 C17068 C17070 C17071	P11120 P12334 P16832 P16868 P16885 P16894 P16899 P16900 P16910 P16920 P16922 P16937 P17039 P17067 P17068 P17070 P17071	1	2		1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Wezlana	TN	MP	C18785 C18825 C18826 C18827 C18856 C18885	P18785 P18825 P18826 P18827 P18856 P18885	2	0	V18826 V18885	1
Ustekinumab	Injection 45 mg in 0.5 mL	Injection	Wezlana	TN	MP	C18721	P18721	2	2		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C16818	P16818	1	0		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C12156 C16835 C16854 C16856 C16886 C16896 C16911 C16925 C16927 C16967 C18723 C18898	P12156 P16835 P16854 P16856 P16886 P16896 P16911 P16925 P16927 P16967 P18723 P18898	1	1		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C11120 C12334 C16832 C16868 C16885 C16894 C16899 C16900 C16910 C16920 C16922 C16937 C17039 C17067 C17068 C17070 C17071	P11120 P12334 P16832 P16868 P16885 P16894 P16899 P16900 P16910 P16920 P16922 P16937 P17039 P17067 P17068 P17070 P17071	1	2		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C18785 C18825 C18827 C18856 C18885	P18785 P18825 P18827 P18856 P18885	2	0	V18885	1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C18721	P18721	2	2		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C16818	P16818	1	0		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C12156 C16835 C16854 C16856 C16886 C16896 C16911 C16925 C16927 C16967 C18723 C18898	P12156 P16835 P16854 P16856 P16886 P16896 P16911 P16925 P16927 P16967 P18723 P18898	1	1		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C11120 C12334 C16832 C16868 C16885 C16894 C16899 C16900 C16910 C16920 C16922 C16937 C17039 C17067 C17068 C17070 C17071	P11120 P12334 P16832 P16868 P16885 P16894 P16899 P16900 P16910 P16920 P16922 P16937 P17039 P17067 P17068 P17070 P17071	1	2		1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C18785 C18825 C18827 C18856 C18885	P18785 P18825 P18827 P18856 P18885	2	0	V18885	1
Ustekinumab	Injection 45 mg in 0.5 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C18721	P18721	2	2		1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Stelara	JC	MP	C16828 C16917 C16918 C19149 C19171 C19172	P16828 P16917 P16918 P19149 P19171 P19172	1	0		1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Stelara	JC	MP	C16915 C16916 C16973 C19193	P16915 P16916 P16973 P19193	1	1	V19193	1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C16828 C16917 C16918 C18785 C18825 C18827 C18856 C18885 C19149 C19171 C19172	P16828 P16917 P16918 P18785 P18825 P18827 P18856 P18885 P19149 P19171 P19172	1	0	V18885	1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C12156 C16835 C16886 C16896 C16911 C16915 C16916 C16927 C16967 C16973 C18723 C18898 C19193	P12156 P16835 P16886 P16896 P16911 P16915 P16916 P16927 P16967 P16973 P18723 P18898 P19193	1	1	V19193	1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Steqeyma	EW	MP	C11120 C12334 C16832 C16868 C16894 C16900 C16920 C16922 C16945 C17039 C17067 C17068 C17070 C17071 C18721 C19174	P11120 P12334 P16832 P16868 P16894 P16900 P16920 P16922 P16945 P17039 P17067 P17068 P17070 P17071 P18721 P19174	1	2		1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C16828 C16917 C16918 C18785 C18825 C18827 C18856 C18885 C19149 C19171 C19172	P16828 P16917 P16918 P18785 P18825 P18827 P18856 P18885 P19149 P19171 P19172	1	0	V18885	1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C12156 C16835 C16886 C16896 C16911 C16915 C16916 C16927 C16967 C16973 C18723 C18898 C19193	P12156 P16835 P16886 P16896 P16911 P16915 P16916 P16927 P16967 P16973 P18723 P18898 P19193	1	1	V19193	1
Ustekinumab	Injection 90 mg in 1 mL single use pre-filled syringe	Injection	Wezlana	TN	MP	C11120 C12334 C16832 C16868 C16894 C16900 C16920 C16922 C16945 C17039 C17067 C17068 C17070 C17071 C18721 C19174	P11120 P12334 P16832 P16868 P16894 P16900 P16920 P16922 P16945 P17039 P17067 P17068 P17070 P17071 P18721 P19174	1	2		1
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Stelara	JC	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Steqeyma	EW	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Wezlana	TN	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX-Valaciclovir	TY	MP NP	C5960	P5960	20	0		10
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX-Valaciclovir	TY	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX-Valaciclovir	TY	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX-Valaciclovir	TY	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX-Valaciclovir	TY	MP	C5975 C9267		500	2		100	C(100)
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Shilova 500	ZS	MP NP MW	C5940		30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Shilova 500	ZS	MP NP	C5961		30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Vaclovir	AF	MP NP	C5960	P5960	20	0		10
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Vaclovir	AF	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Vaclovir	AF	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Vaclovir	AF	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir RBX	RA	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir RBX	RA	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir RBX	RA	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir RBX	RA	MP	C5975 C9267		500	2		100	C(100)
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir Sandoz	SZ	MP NP	C5960	P5960	20	0		10
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir Sandoz	SZ	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir Sandoz	SZ	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir Sandoz	SZ	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir SZ	HX	MP NP MW	C5940		30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir SZ	HX	MP NP	C5961		30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	VALACICLOVIR-WGR	WG	MP NP	C5960	P5960	20	0		10
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	VALACICLOVIR-WGR	WG	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	VALACICLOVIR-WGR	WG	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	VALACICLOVIR-WGR	WG	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	RW	MP NP	C5960	P5960	20	0		10
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	RW	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	RW	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	RW	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex	RW	MP	C5975 C9267		500	2		100	C(100)
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Zelitrex	RF	MP NP	C5960	P5960	20	0		10
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Zelitrex	RF	MP NP MW	C5940	P5940	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Zelitrex	RF	MP NP	C5961	P5961	30	5		30
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Zelitrex	RF	MP NP	C5962 C5968	P5962 P5968	42	0		42
Valganciclovir	Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL	Oral	Valcyte	PB	MP NP	C4980		11	5		1	D(100)
Valganciclovir	Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL	Oral	Valcyte	PB	MP	C15782 C15784 C15800 C15814		11	5		1	D(100)
Valganciclovir	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Sandoz	SZ	MP NP	C4980		120	5		60	D(100)
Valganciclovir	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Sandoz	SZ	MP	C15782 C15784 C15800 C15814		120	5		60	D(100)
Valganciclovir	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Viatris	AL	MP NP	C4980		120	5		60	D(100)
Valganciclovir	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Viatris	AL	MP	C15782 C15784 C15800 C15814		120	5		60	D(100)
Valine with carbohydrate	Sachets of oral powder 4 g containing 1 g valine, 30 (Valine 1000)	Oral	Valine 1000	VF	MP NP	C5571		4	5		1
Valine with carbohydrate	Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine 50)	Oral	Valine 50	VF	MP NP	C5571		4	5		1
Valproic acid	Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL	Oral	Epilim Liquid	SW	MP NP	C16524	P16524	2	2		1
Valproic acid	Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL	Oral	Epilim Liquid	SW	MP NP	C16493	P16493	4	2		1
Valproic acid	Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL	Oral	Epilim Syrup	SW	MP NP	C16524	P16524	2	2		1
Valproic acid	Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL	Oral	Epilim Syrup	SW	MP NP	C16493	P16493	4	2		1
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	APO-Sodium Valproate	TX	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	APO-Sodium Valproate	TX	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Epilim EC	SW	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Epilim EC	SW	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Sodium Valproate Sandoz	SZ	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Sodium Valproate Sandoz	SZ	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Valpro EC 200	AF	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Valpro EC 200	AF	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Valproate Winthrop EC 200	WA	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Valproate Winthrop EC 200	WA	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	APO-Sodium Valproate	TX	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	APO-Sodium Valproate	TX	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Epilim EC	SW	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Epilim EC	SW	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Sodium Valproate Sandoz	SZ	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Sodium Valproate Sandoz	SZ	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Valpro EC 500	AF	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Valpro EC 500	AF	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Valproate Winthrop EC 500	WA	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Valproate Winthrop EC 500	WA	MP NP	C16493	P16493	400	2		100
Valproic acid	Tablet, crushable, containing sodium valproate 100 mg	Oral	Epilim	SW	MP NP	C16524	P16524	200	2		100
Valproic acid	Tablet, crushable, containing sodium valproate 100 mg	Oral	Epilim	SW	MP NP	C16493	P16493	400	2		100
Valsartan	Tablet 40 mg	Oral	Dilart	AF	MP NP			28	0		28
Valsartan	Tablet 40 mg	Oral	Diovan	NV	MP NP			28	0		28
Valsartan	Tablet 80 mg	Oral	Dilart	AF	MP NP			28	5		28
Valsartan	Tablet 80 mg	Oral	Dilart	AF	MP NP		P14238	56	5		28
Valsartan	Tablet 80 mg	Oral	Diovan	NV	MP NP			28	5		28
Valsartan	Tablet 80 mg	Oral	Diovan	NV	MP NP		P14238	56	5		28
Valsartan	Tablet 160 mg	Oral	Dilart	AF	MP NP			28	5		28
Valsartan	Tablet 160 mg	Oral	Dilart	AF	MP NP		P14238	56	5		28
Valsartan	Tablet 160 mg	Oral	Diovan	NV	MP NP			28	5		28
Valsartan	Tablet 160 mg	Oral	Diovan	NV	MP NP		P14238	56	5		28
Valsartan	Tablet 320 mg	Oral	Dilart	AF	MP NP			28	5		28
Valsartan	Tablet 320 mg	Oral	Dilart	AF	MP NP		P14238	56	5		28
Valsartan	Tablet 320 mg	Oral	Diovan	NV	MP NP			28	5		28
Valsartan	Tablet 320 mg	Oral	Diovan	NV	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Co-Diovan 80/12.5	NV	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Co-Diovan 80/12.5	NV	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Dilart HCT 80/12.5	AF	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Dilart HCT 80/12.5	AF	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-12.5 mg	Oral	Co-Diovan 160/12.5	NV	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-12.5 mg	Oral	Co-Diovan 160/12.5	NV	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-12.5 mg	Oral	Dilart HCT 160/12.5	AF	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-12.5 mg	Oral	Dilart HCT 160/12.5	AF	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-25 mg	Oral	Co-Diovan 160/25	NV	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-25 mg	Oral	Co-Diovan 160/25	NV	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-25 mg	Oral	Dilart HCT 160/25	AF	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 160 mg-25 mg	Oral	Dilart HCT 160/25	AF	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-12.5 mg	Oral	Co-Diovan 320/12.5	NV	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-12.5 mg	Oral	Co-Diovan 320/12.5	NV	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-12.5 mg	Oral	Dilart HCT 320/12.5	AF	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-12.5 mg	Oral	Dilart HCT 320/12.5	AF	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-25 mg	Oral	Co-Diovan 320/25	NV	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-25 mg	Oral	Co-Diovan 320/25	NV	MP NP		P14238	56	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-25 mg	Oral	Dilart HCT 320/25	AF	MP NP			28	5		28
Valsartan with hydrochlorothiazide	Tablet 320 mg-25 mg	Oral	Dilart HCT 320/25	AF	MP NP		P14238	56	5		28
Vancomycin	Capsule 125 mg (125,000 I.U.) (as hydrochloride)	Oral	Vancocin	AS	MP NP	C5636 C5660		40	0		20
Vancomycin	Capsule 125 mg (125,000 I.U.) (as hydrochloride)	Oral	Vancomycin BNM 125mg	BZ	MP NP	C5636 C5660		40	0		20
Vancomycin	Capsule 125 mg (125,000 I.U.) (as hydrochloride)	Oral	VANCOR	CR	MP NP	C5636 C5660		40	0		20
Vancomycin	Capsule 250 mg (250,000 I.U.) (as hydrochloride)	Oral	Vancocin	AS	MP NP	C5636 C5660		40	0		20
Vancomycin	Capsule 250 mg (250,000 I.U.) (as hydrochloride)	Oral	Vancomycin BNM 250mg	BZ	MP NP	C5636 C5660		40	0		20
Vancomycin	Capsule 250 mg (250,000 I.U.) (as hydrochloride)	Oral	VANCOR	CR	MP NP	C5636 C5660		40	0		20
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	MP	C5717	P5717	2	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	PDP	C5801	P5801	2	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	MP MW	C5769	P5769	5	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	MP	C5716	P5716	5	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	MP	C5717	P5717	2	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	PDP	C5801	P5801	2	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	MP MW	C5769	P5769	5	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	MP	C5716	P5716	5	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	MP	C5717	P5717	2	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	PDP	C5801	P5801	2	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	MP MW	C5769	P5769	5	0		1
Vancomycin	Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	MP	C5716	P5716	5	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	MP	C5717	P5717	1	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	PDP	C5801	P5801	1	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	MP MW	C5769	P5769	3	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Juno	XT	MP	C5716	P5716	3	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	MP	C5717	P5717	1	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	PDP	C5801	P5801	1	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	MP MW	C5769	P5769	3	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	VANCOMYCIN MEDSURGE	DZ	MP	C5716	P5716	3	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	MP	C5717	P5717	1	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	PDP	C5801	P5801	1	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	MP MW	C5769	P5769	3	0		1
Vancomycin	Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)	Injection	Vancomycin Viatris	AL	MP	C5716	P5716	3	0		1
Vanzacaftor with tezacaftor and with deutivacaftor	Tablet containing 4 mg vanzacaftor (as calcium) with 20 mg tezacaftor and with 50 mg deutivacaftor	Oral	Alyftrek	VR	MP	See Note 3	See Note 3	See Note 3	See Note 3		84	D(100)
Vanzacaftor with tezacaftor and with deutivacaftor	Tablet containing 10 mg vanzacaftor (as calcium) with 50 mg tezacaftor and with 125 mg deutivacaftor	Oral	Alyftrek	VR	MP	See Note 3	See Note 3	See Note 3	See Note 3		56	D(100)
Varenicline	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	PHARMACOR VARENICLINE	CR	MP NP	C6871		1	0		1
Varenicline	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	VARENAPIX	TX	MP NP	C6871		1	0		1
Varenicline	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	Varenicline Lupin	GQ	MP NP	C6871		1	0		1
Varenicline	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	Varenicline Sandoz	SZ	MP NP	C6871		1	0		1
Varenicline	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	Varenicline Viatris	AF	MP NP	C6871		1	0		1
Varenicline	Box containing 11 tablets 0.5 mg and 42 tablets 1 mg	Oral	VASSIX	NB	MP NP	C6871		1	0		1
Varenicline	Tablet 1 mg	Oral	PHARMACOR VARENICLINE	CR	MP NP	C6885	P6885	56	2		56
Varenicline	Tablet 1 mg	Oral	PHARMACOR VARENICLINE	CR	MP NP	C7483	P7483	112	0		56
Varenicline	Tablet 1 mg	Oral	VARENAPIX	TX	MP NP	C6885	P6885	56	2		56
Varenicline	Tablet 1 mg	Oral	VARENAPIX	TX	MP NP	C7483	P7483	112	0		56
Varenicline	Tablet 1 mg	Oral	Varenicline Lupin	GQ	MP NP	C6885	P6885	56	2		56
Varenicline	Tablet 1 mg	Oral	Varenicline Lupin	GQ	MP NP	C7483	P7483	112	0		56
Varenicline	Tablet 1 mg	Oral	Varenicline Sandoz	SZ	MP NP	C6885	P6885	56	2		56
Varenicline	Tablet 1 mg	Oral	Varenicline Sandoz	SZ	MP NP	C7483	P7483	112	0		56
Varenicline	Tablet 1 mg	Oral	Varenicline Viatris	AF	MP NP	C6885	P6885	56	2		56
Varenicline	Tablet 1 mg	Oral	Varenicline Viatris	AF	MP NP	C7483	P7483	112	0		56
Varenicline	Tablet 1 mg	Oral	VASSIX	NB	MP NP	C6885	P6885	56	2		56
Varenicline	Tablet 1 mg	Oral	VASSIX	NB	MP NP	C7483	P7483	112	0		56
Vedolizumab	Injection 108 mg in 0.68 mL single use pre-filled pen	Injection	Entyvio	TK	MP	C13237 C15944 C18860 C18877 C18878 C18909	P13237 P15944 P18860 P18877 P18878 P18909	2	0		2
Vedolizumab	Injection 108 mg in 0.68 mL single use pre-filled pen	Injection	Entyvio	TK	MP	C15943 C18879 C18904	P15943 P18879 P18904	2	5		2
Vedolizumab	Powder for injection 300 mg	Injection	Entyvio	TK	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	PB(100)
Vemurafenib	Tablet 240 mg	Oral	Zelboraf	RO	MP	C10157	P10157	224	3		56
Vemurafenib	Tablet 240 mg	Oral	Zelboraf	RO	MP NP	C17949	P17949	224	5		56
Venetoclax	Pack containing 14 tablets venetoclax 10 mg and 7 tablets venetoclax 50 mg and 7 tablets venetoclax 100 mg and 14 tablets venetoclax 100 mg	Oral	Venclexta	VE	MP	C14776 C15905 C18666 C18683		1	0		1
Venetoclax	Tablet 10 mg	Oral	Venclexta	VE	MP	C10995		14	0		2
Venetoclax	Tablet 50 mg	Oral	Venclexta	VE	MP	C10995	P10995	7	0		7
Venetoclax	Tablet 50 mg	Oral	Venclexta	VE	MP	C12462	P12462	28	2		7
Venetoclax	Tablet 100 mg	Oral	Venclexta	VE	MP	C12462	P12462	120	2		120
Venetoclax	Tablet 100 mg	Oral	Venclexta	VE	MP	C15907 C18648 C18687	P15907 P18648 P18687	120	4		120
Venetoclax	Tablet 100 mg	Oral	Venclexta	VE	MP	C11069 C15904 C18665 C18667	P11069 P15904 P18665 P18667	120	5		120
Venlafaxine	Capsule (modified release) 37.5 mg (as hydrochloride)	Oral	Efexor-XR	GO	MP NP	C5650		28	0		28
Venlafaxine	Capsule (modified release) 37.5 mg (as hydrochloride)	Oral	Elaxine SR 37.5	RW	MP NP	C5650		28	0		28
Venlafaxine	Capsule (modified release) 37.5 mg (as hydrochloride)	Oral	VENLAFAXINE XR-WGR	WG	MP NP	C5650		28	0		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	APO-Venlafaxine XR	TX	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	APO-Venlafaxine XR	TX	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	BTC Venlafaxine XR	BG	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	BTC Venlafaxine XR	BG	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Efexor-XR	GO	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Efexor-XR	GO	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Elaxine SR 75	RW	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Elaxine SR 75	RW	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Enlafax-XR	AF	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Enlafax-XR	AF	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Sandoz Venlafaxine XR	HX	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Sandoz Venlafaxine XR	HX	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Venlafaxine generichealth XR	GQ	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	Venlafaxine generichealth XR	GQ	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	VENLAFAXINE XR-WGR	WG	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 75 mg (as hydrochloride)	Oral	VENLAFAXINE XR-WGR	WG	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	APO-Venlafaxine XR	TX	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	APO-Venlafaxine XR	TX	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	BTC Venlafaxine XR	BG	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	BTC Venlafaxine XR	BG	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Efexor-XR	GO	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Efexor-XR	GO	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Elaxine SR 150	RW	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Elaxine SR 150	RW	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Enlafax-XR	AF	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Enlafax-XR	AF	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Sandoz Venlafaxine XR	HX	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Sandoz Venlafaxine XR	HX	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Venlafaxine generichealth XR	GQ	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	Venlafaxine generichealth XR	GQ	MP NP	C15553	P15553	56	2		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	VENLAFAXINE XR-WGR	WG	MP NP	C5650	P5650	28	5		28
Venlafaxine	Capsule (modified release) 150 mg (as hydrochloride)	Oral	VENLAFAXINE XR-WGR	WG	MP NP	C15553	P15553	56	2		28
Verapamil	Tablet containing verapamil hydrochloride 80 mg	Oral	Anpec 80	AF	MP NP			100	5		100
Verapamil	Tablet containing verapamil hydrochloride 80 mg	Oral	Anpec 80	AF	MP NP		P14238	200	5		100
Verapamil	Tablet containing verapamil hydrochloride 80 mg	Oral	Isoptin	GO	MP NP			100	5		100
Verapamil	Tablet containing verapamil hydrochloride 80 mg	Oral	Isoptin	GO	MP NP		P14238	200	5		100
Verapamil	Tablet containing verapamil hydrochloride 180 mg (sustained release)	Oral	Cordilox 180 SR	GT	MP NP			30	5		30
Verapamil	Tablet containing verapamil hydrochloride 180 mg (sustained release)	Oral	Cordilox 180 SR	GT	MP NP		P14238	60	5		30
Verapamil	Tablet containing verapamil hydrochloride 180 mg (sustained release)	Oral	Isoptin 180 SR	GO	MP NP			30	5		30
Verapamil	Tablet containing verapamil hydrochloride 180 mg (sustained release)	Oral	Isoptin 180 SR	GO	MP NP		P14238	60	5		30
Verapamil	Tablet containing verapamil hydrochloride 240 mg (sustained release)	Oral	Cordilox SR	GT	MP NP			30	5		30
Verapamil	Tablet containing verapamil hydrochloride 240 mg (sustained release)	Oral	Cordilox SR	GT	MP NP		P14238	60	5		30
Verapamil	Tablet containing verapamil hydrochloride 240 mg (sustained release)	Oral	Isoptin SR	GO	MP NP			30	5		30
Verapamil	Tablet containing verapamil hydrochloride 240 mg (sustained release)	Oral	Isoptin SR	GO	MP NP		P14238	60	5		30
Vericiguat	Tablet 2.5 mg	Oral	Verquvo	BN	MP NP	C13561 C16562		28	5		28
Vericiguat	Tablet 5 mg	Oral	Verquvo	BN	MP NP	C13561 C16562		28	5		28
Vericiguat	Tablet 10 mg	Oral	Verquvo	BN	MP NP	C13561 C16562		28	5		28
Vigabatrin	Oral powder, sachet 500 mg	Oral	Sabril	SW	MP NP	C17445	P17445	60	5		60
Vigabatrin	Oral powder, sachet 500 mg	Oral	Sabril	SW	MP NP	C17444	P17444	120	5		60
Vigabatrin	Tablet 500 mg	Oral	Sabril	SW	MP NP	C17445	P17445	100	5		100
Vigabatrin	Tablet 500 mg	Oral	Sabril	SW	MP NP	C17444	P17444	200	5		100
Vildagliptin	Tablet 50 mg	Oral	Galvus	NV	MP NP	C15261	P15261	60	5		60
Vildagliptin	Tablet 50 mg	Oral	Galvus	NV	MP NP	C15287	P15287	120	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/1000	XT	MP NP	C15276	P15276	60	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/1000	XT	MP NP	C15288	P15288	120	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride	Oral	Galvumet 50/1000	NV	MP NP	C15276	P15276	60	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride	Oral	Galvumet 50/1000	NV	MP NP	C15288	P15288	120	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/500	XT	MP NP	C15276	P15276	60	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/500	XT	MP NP	C15288	P15288	120	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride	Oral	Galvumet 50/500	NV	MP NP	C15276	P15276	60	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride	Oral	Galvumet 50/500	NV	MP NP	C15288	P15288	120	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/850	XT	MP NP	C15276	P15276	60	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride	Oral	ARX-Vildagliptin/Metformin 50/850	XT	MP NP	C15288	P15288	120	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride	Oral	Galvumet 50/850	NV	MP NP	C15276	P15276	60	5		60
Vildagliptin with metformin	Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride	Oral	Galvumet 50/850	NV	MP NP	C15288	P15288	120	5		60
Vinblastine	Solution for I.V. injection containing vinblastine sulfate 10 mg in 10 mL	Injection	DBL Vinblastine	PF	MP			See Note 3	See Note 3		5	D(100)
Vincristine	I.V. injection containing vincristine sulfate 1 mg in 1 mL	Injection	DBL Vincristine Sulfate	PF	MP			See Note 3	See Note 3		5	D(100)
Vinorelbine	Capsule 20 mg (as tartrate)	Oral	Velabine	XT	MP NP	C17855 C18015		20	2		1
Vinorelbine	Capsule 30 mg (as tartrate)	Oral	Velabine	XT	MP NP	C17855 C18015		16	2		1
Vinorelbine	Solution for I.V. infusion 10 mg (as tartrate) in 1 mL	Injection	Vinorelbine Ebewe	SZ	MP			See Note 3	See Note 3		1	PB(100)
Vinorelbine	Solution for I.V. infusion 50 mg (as tartrate) in 5 mL	Injection	Vinorelbine Ebewe	SZ	MP			See Note 3	See Note 3		1	PB(100)
Vismodegib	Capsule 150 mg	Oral	Erivedge	RO	MP	C7491 C18251 C18252		28	3		28
Vitamins, minerals and trace elements formula	Sachets containing oral powder 7 g, 30 (Phlexy-Vits)	Oral	Phlexy-Vits	SB	MP NP	C7275		1	5		1
Vitamins, minerals and trace elements with carbohydrate	Oral powder 200 g (Paediatric Seravit)	Oral	Paediatric Seravit	SB	MP NP	C6152		6	5		1
Vitamins, minerals and trace elements with carbohydrate	Sachets containing oral powder 6 g, 30 (FruitiVits)	Oral	FruitiVits	VF	MP NP	C6159		1	5		1
Vorasidenib	Tablet 10 mg	Oral	Voranigo	SE	MP	C18999 C19016 C19035		60	5		30
Vorasidenib	Tablet 40 mg	Oral	Voranigo	SE	MP	C18999 C19016 C19035		30	5		30
Voriconazole	Powder for oral suspension 40 mg per mL, 70 mL	Oral	Vfend	PF	MP NP	C15979 C15981 C16042 C16094 C16115		1	0		1
Voriconazole	Tablet 50 mg	Oral	Voriconazole Sandoz	SZ	MP NP	C16115	P16115	56	0		56
Voriconazole	Tablet 50 mg	Oral	Voriconazole Sandoz	SZ	MP NP	C15979 C15981 C16042 C16094	P15979 P15981 P16042 P16094	56	2		56
Voriconazole	Tablet 50 mg	Oral	Vttack	AF	MP NP	C16115	P16115	56	0		56
Voriconazole	Tablet 50 mg	Oral	Vttack	AF	MP NP	C15979 C15981 C16042 C16094	P15979 P15981 P16042 P16094	56	2		56
Voriconazole	Tablet 50 mg	Oral	Vzole	RW	MP NP	C16115	P16115	56	0		56
Voriconazole	Tablet 50 mg	Oral	Vzole	RW	MP NP	C15979 C15981 C16042 C16094	P15979 P15981 P16042 P16094	56	2		56
Voriconazole	Tablet 200 mg	Oral	Voriconazole Sandoz	SZ	MP NP	C16115	P16115	56	0		56
Voriconazole	Tablet 200 mg	Oral	Voriconazole Sandoz	SZ	MP NP	C15979 C15981 C16042 C16094	P15979 P15981 P16042 P16094	56	2		56
Voriconazole	Tablet 200 mg	Oral	Vttack	AF	MP NP	C16115	P16115	56	0		56
Voriconazole	Tablet 200 mg	Oral	Vttack	AF	MP NP	C15979 C15981 C16042 C16094	P15979 P15981 P16042 P16094	56	2		56
Voriconazole	Tablet 200 mg	Oral	Vzole	RW	MP NP	C16115	P16115	56	0		56
Voriconazole	Tablet 200 mg	Oral	Vzole	RW	MP NP	C15979 C15981 C16042 C16094	P15979 P15981 P16042 P16094	56	2		56
Vorinostat	Capsule 100 mg	Oral	Zolinza	MK	MP	C13246	P13246	120	1		120
Vorinostat	Capsule 100 mg	Oral	Zolinza	MK	MP	C18425	P18425	120	2		120
Vosoritide	Powder for injection 400 micrograms with diluent	Injection	Voxzogo	IO	MP	C13977 C13998		30	5	V13977 V13998	10
Vosoritide	Powder for injection 560 micrograms with diluent	Injection	Voxzogo	IO	MP	C13977 C13998		30	5	V13977 V13998	10
Vosoritide	Powder for injection 1.2 mg with diluent	Injection	Voxzogo	IO	MP	C13977 C13998		30	5	V13977 V13998	10
Vutrisiran	Injection 25 mg (as sodium) in 0.5 mL pre-filled syringe	Injection	Amvuttra	WM	MP	See Note 3	See Note 3	See Note 3	See Note 3		1	D(100)
Warfarin	Tablet containing warfarin sodium 1 mg	Oral	Coumadin	GO	MP NP			50	2		50
Warfarin	Tablet containing warfarin sodium 1 mg	Oral	Marevan	GT	MP NP			50	2		50
Warfarin	Tablet containing warfarin sodium 2 mg	Oral	Coumadin	GO	MP NP			50	2		50
Warfarin	Tablet containing warfarin sodium 3 mg	Oral	Marevan	GT	MP NP			50	2		50
Warfarin	Tablet containing warfarin sodium 5 mg	Oral	Coumadin	GO	MP NP			50	2		50
Warfarin	Tablet containing warfarin sodium 5 mg	Oral	Marevan	GT	MP NP			50	2		50
Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose	Oral powder 400 g, 6 (Renastart)	Oral	Renastart	VF	MP NP	C6190		4	5		1
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose	Oral powder 400 g (Kindergen)	Oral	Kindergen	SB	MP NP	C6190		16	5		1
Zanubrutinib	Capsule 80 mg	Oral	Brukinsa	IE	MP NP	C17898 C17927 C17930 C17931 C17961 C18007		120	5		120
Zidovudine	Capsule 100 mg	Oral	Retrovir	VI	MP NP	C4454 C4512		400	5		100	D(100)
Zidovudine	Capsule 250 mg	Oral	Retrovir	VI	MP NP	C4454 C4512		240	5		40	D(100)
Zidovudine	Syrup 10 mg per mL, 200 mL	Oral	Retrovir	VI	MP NP	C4454 C4512		15	5		1	D(100)
Zilucoplan	Solution for injection 16.6 mg in 0.416 mL (as tetrasodium) pre-filled syringe	Injection	Zilbrysq	UC	MP	See Note 3	See Note 3	See Note 3	See Note 3		28	D(100)
Zilucoplan	Solution for injection 23 mg in 0.574 mL (as tetrasodium) pre-filled syringe	Injection	Zilbrysq	UC	MP	See Note 3	See Note 3	See Note 3	See Note 3		28	D(100)
Zilucoplan	Solution for injection 32.4 mg in 0.810 mL (as tetrasodium) pre-filled syringe	Injection	Zilbrysq	UC	MP	See Note 3	See Note 3	See Note 3	See Note 3		28	D(100)
Ziprasidone	Capsule 20 mg (as hydrochloride)	Oral	Zeldox	GO	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 20 mg (as hydrochloride)	Oral	Ziprasidone GH	GQ	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 20 mg (as hydrochloride)	Oral	ZIPROX	RW	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 40 mg (as hydrochloride)	Oral	Zeldox	GO	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 40 mg (as hydrochloride)	Oral	Ziprasidone GH	GQ	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 40 mg (as hydrochloride)	Oral	ZIPROX	RW	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 60 mg (as hydrochloride)	Oral	Zeldox	GO	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 60 mg (as hydrochloride)	Oral	Ziprasidone GH	GQ	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 60 mg (as hydrochloride)	Oral	ZIPROX	RW	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 80 mg (as hydrochloride)	Oral	Zeldox	GO	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 80 mg (as hydrochloride)	Oral	Ziprasidone GH	GQ	MP NP	C4246 C5742		60	5		60
Ziprasidone	Capsule 80 mg (as hydrochloride)	Oral	ZIPROX	RW	MP NP	C4246 C5742		60	5		60
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	APO-Zoledronic Acid	TX	MP	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328		1	11		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	DEZTRON	DZ	MP	C14729 C14735	P14729 P14735	1	0		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	DEZTRON	DZ	MP	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronate-DRLA 4	RZ	MP	C14729 C14735	P14729 P14735	1	0		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronate-DRLA 4	RZ	MP	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronic Acid Accord	OC	MP	C14729 C14735	P14729 P14735	1	0		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronic Acid Accord	OC	MP	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11		1	PB(100)
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zometa	SA	MP	C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328		1	11		1	PB(100)
Zoledronic acid	Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL	Injection	Aclasta	HX	MP	C5710 C6308 C6313 C6318		1	0		1
Zoledronic acid	Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL	Injection	Osteovan	SZ	MP	C5710 C6308 C6313 C6318		1	0		1
Zoledronic acid	Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL	Injection	Zoledasta	TX	MP	C5710 C6308 C6313 C6318		1	0		1
Zoledronic acid	Solution for I.V. infusion 5 mg (as monohydrate) in 100 mL	Injection	Zoledronate-RDY 5	RI	MP	C5710 C6308 C6313 C6318		1	0		1
Zolmitriptan	Tablet 2.5 mg	Oral	APO-Zolmitriptan	TX	MP NP	C5141		4	5		2
Zolmitriptan	Tablet 2.5 mg	Oral	Zoltrip	RW	MP NP	C5141		4	5		2
Zolmitriptan	Tablet 2.5 mg	Oral	Zomig	AS	MP NP	C5141		4	5		2
Zonisamide	Capsule 25 mg	Oral	Zonegran	GH	MP NP	C17445	P17445	56	5		56
Zonisamide	Capsule 25 mg	Oral	Zonegran	GH	MP NP	C17444	P17444	112	5		56
Zonisamide	Capsule 50 mg	Oral	Zonegran	GH	MP NP	C17445	P17445	56	5		56
Zonisamide	Capsule 50 mg	Oral	Zonegran	GH	MP NP	C17444	P17444	112	5		56
Zonisamide	Capsule 100 mg	Oral	Zonegran	GH	MP NP	C17445	P17445	112	5		56
Zonisamide	Capsule 100 mg	Oral	Zonegran	GH	MP NP	C17444	P17444	224	5		56
Zuclopenthixol decanoate	Oily I.M. injection 200 mg in 1 mL	Injection	Clopixol Depot	LU	MP NP	C15956		5	0		5

Note 2: The pharmaceutical benefit may be covered by a special arrangement under section 100 of the Act. The matters determined for the pharmaceutical benefit in this instrument relate to its general supply under Part VII of the Act, and may be modified in the special arrangement instrument. When the pharmaceutical benefit is supplied under the special arrangement, the modified matters will apply.

Note 3: This matter has not been determined for the pharmaceutical benefit in this instrument. The pharmaceutical benefit can only be supplied, or can only be supplied in the circumstances mentioned, under special arrangements under section 100 of the Act. The matter may be determined in a special arrangement instrument.

Note 4: The pharmaceutical benefit may be supplied only under the particular prescriber bag provisions of the Act indicated by the code or codes in the column headed 'Section 100/Prescriber Bag only'. It is not able to be prescribed as a pharmaceutical benefit. The maximum quantity of the pharmaceutical benefit that may be obtained by the particular prescriber for direct supply from their prescriber bag is determined in a legislative instrument made under the relevant prescriber bag provisions of the Act (sections 93, 93AA and 93AB).

Part 2 · Ready-prepared pharmaceutical benefits for supply only

2Matters relating to pharmaceutical benefits#

The following table sets out pharmaceutical benefits and matters relating to pharmaceutical benefits and their supply, for the purposes of sections 6 to 10 and 20 to 23.

Listed Drug	Form	Manner of Administration	Brand	Responsible Person	Pack Quantity
Beclometasone	Pressurised inhalation in breath actuated device containing beclometasone dipropionate 100 micrograms per dose, 200 doses (CFC-free formulation)	Inhalation by mouth	Qvar 100 Autohaler	IL	1
Glyceryl trinitrate	Transdermal patch 18 mg	Transdermal	Minitran 5	IL	30
Methylphenidate	Tablet containing methylphenidate hydrochloride 27 mg (modified release) (Spain) (S19A)	Oral	Atenza (Spain)	XT	30
Methylphenidate	Tablet containing methylphenidate hydrochloride 54 mg (modified release) (Spain) (S19A)	Oral	Atenza (Spain)	XT	30
Miconazole	Tincture 20 mg per mL, 30 mL	Application	Daktarin Tincture	JT	1
Paraffin	Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g	Application to the eye	Poly Visc	IQ	1
Selpercatinib	Capsule 40 mg	Oral	Retevmo	LY	56
Selpercatinib	Capsule 80 mg	Oral	Retevmo	LY	56

Schedule 2 · Extemporaneously-prepared pharmaceutical benefits

Note: See the definition of extemporaneously-prepared pharmaceutical benefit in section 5, and sections 6, 14, 17 and 18.

Part 1 · Listed drugs that are or may be contained in extemporaneously-prepared pharmaceutical benefits

1Listed drugs and circumstances#

The following table sets out listed drugs and matters relating to their prescription, for the purposes of sections 6 and 14.

Listed drugs and circumstances
	Column 1	Column 2
Item	Listed drug	Circumstances
1	Acacia BP, powdered
2	Acetic Acid (33 per cent) BP
3	Alum BP
4	Aluminium Acetate Solution BP
5	Aqueous Cream APF	For use only as a base combined with active ingredients
6	Ascorbic Acid BP	For use only as an ingredient of ferrous sulfate mixtures
7	Aspirin BP
8	Belladonna Tincture BP
9	Benzocaine BP
10	Benzoic Acid BP
11	Benzoin Tincture Compound BP
12	Boric Acid, Olive Oil and Zinc Oxide Ointment QHF
13	Calcium Hydroxide BP
14	Cetomacrogol Cream, Aqueous APF	For use only as a base combined with active ingredients
15	Cetrimide Cream, Aqueous APF	For use only as a base combined with active ingredients
16	Chlorhexidine Cream, Aqueous APF	For use only as a base combined with active ingredients
17	Citric Acid Monohydrate BP
18	Coal Tar BP
19	Coal Tar Solution BP
20	Cocaine Hydrochloride BP
21	Coconut Oil BP
22	Codeine Phosphate BP	May only be prescribed in linctuses, mixtures and mixtures for children
23	Collodion Flexible BP
24	Dithranol BP
25	Emulsifying Ointment BP	For use only as a base combined with active ingredients
26	Ephedrine Hydrochloride BP	May only be prescribed in nasal instillations
27	Ferrous Sulfate BP
28	Formaldehyde Solution BP
29	Gentian Alkaline Mixture APF
30	Glycerol BP
31	Iodine BP
32	Kaolin Mixture BPC 1968
33	Kaolin and Opium Mixture APF 14
34	Lactic Acid BP
35	Lavender Oil, Spike BPC 1968
36	Levomenthol BP
37	Liquorice Liquid Extract BP
38	Magnesium Carbonate, Light BP
39	Magnesium Sulfate BP	May only be prescribed for other than oral use
40	Magnesium Trisilicate BP
41	Menthol, Racemic BP
42	Methyl Hydroxybenzoate BP
43	Paraffin, Hard BP
44	Paraffin, Light Liquid BP
45	Paraffin, Liquid BP	May only be prescribed for other than oral use
46	Paraffin, Soft White BP
47	Phenobarbitone Sodium BP	May only be prescribed for the treatment of epilepsy
48	Phenol, Liquefied BP	Not available for ear drops
49	Podophyllum Resin BP
50	Potassium Citrate BP
51	Potassium Iodide BP
52	Potassium Permanganate BP
53	Propyl Hydroxybenzoate BP
54	Propylene Glycol BP
55	Resorcinol BP
56	Salicylic Acid BP
57	Simple Ointment (white) BP	For use only as a base combined with active ingredients
58	Simple Ointment (yellow) BP	For use only as a base combined with active ingredients
59	Sodium Bicarbonate BP
60	Sodium Chloride BP
61	Sodium Citrate BP
62	Starches BP
63	Sulfur, Precipitated BP 1980
64	Syrup BP
65	Talc, Purified BP, sterilised
66	Thymol BP
67	Thymol Mouth Wash, Compound APF 15
68	Tragacanth BP, powdered
69	Tragacanth Powder, Compound BP 1980
70	Trichloroacetic Acid BP 1980
71	Triethanolamine BP
72	Water For Injections, sterilised BP	May only be prescribed in eye drops and eye lotions
73	Water, Purified BP
74	Wool Alcohols Ointment (white) BP	For use only as a base combined with active ingredients
75	Wool Alcohols Ointment (yellow) BP	For use only as a base combined with active ingredients
76	Wool Fat BP
77	Wool Fat, Hydrous BP
78	Zinc Cream BP	For use only as a base combined with active ingredients
79	Zinc Oxide BP
80	Zinc Sulfate BP

Part 2 · Additives that may be contained in extemporaneously-prepared pharmaceutical benefits

2Additives#

The following table sets out additives for the purposes of paragraph 6(3)(b).

Additives
	Column 1
Item	Additive
1	Acetone BP
2	Anise Water, Concentrated BP
3	Boric Acid BP
4	Castor Oil BP
5	Chlorhexidine Acetate BP
6	Chloroform BP
7	Ethanol (96 per cent) BP
8	Ethanols, Dilute BP
9	Ether, Solvent BP
10	Eucalyptus Oil BP
11	Honey, Purified BP 1993
12	Industrial Methylated Spirit BP
13	Olive Oil BP
14	Peppermint Oil BP
15	Peppermint Water, Concentrated APF
16	Sodium Thiosulfate BP

Part 3 · Maximum quantity and number of repeats

3Maximum quantity and number of repeats#

The following table sets out the maximum quantity and number of repeats for types of pharmaceutical benefits, for the purposes of sections 17 and 18.

Maximum quantity and number of repeats
	Column 1	Column 2	Column 3
Item	Type of pharmaceutical benefit	Maximum quantity	Number of repeats
1	Creams	100 g	1
2	Dusting Powders	100 g	1
3	Ear Drops	15 mL	2
4	Eye Drops containing Cocaine Hydrochloride BP	15 mL	..
5	Eye Drops, Other	15 mL	5
6	Eye Lotions	200 mL	2
7	Inhalations	50 mL	1
8	Linctuses containing Codeine Phosphate BP	100 mL	..
9	Linctuses, Other	100 mL	2
10	Lotions	200 mL	2
11	Mixtures containing Codeine Phosphate BP	200 mL	..
12	Mixtures, Other	200 mL	4
13	Mixtures for Children containing Codeine Phosphate BP	100 mL	..
14	Mixtures for Children, Other	100 mL	4
15	Mouth Washes	200 mL	1
16	Nasal Instillations	15 mL	2
17	Ointments, Waxes	100 g	1
18	Paints	25 mL	1
19	Pastes containing Cocaine Hydrochloride BP	25 g	..
20	Pastes, Other	100 g	1
21	Powders for Internal Use	100 g	2
22	Solutions	200 mL	2

Schedule 3 · Responsible persons

Note: See section 10.

1Codes representing persons#

The following table has effect for the purposes of section 10.

Code	Responsible Person	ABN
AB	Abbott Australasia Pty Ltd	95 000 180 389
AE	AFT Pharmaceuticals (AU) Pty Ltd	29 105 636 413
AF	Alphapharm Pty Ltd	93 002 359 739
AL	Alphapharm Pty Ltd	93 002 359 739
AN	Amgen Australia Pty Limited	31 051 057 428
AP	AstraZeneca Pty Ltd	54 009 682 311
AQ	Alcon Laboratories (Australia) Pty Ltd	88 000 740 830
AS	Aspen Pharmacare Australia Pty Limited	51 096 236 985
AV	sanofi-aventis Australia Pty Ltd	31 008 558 807
BB	Blackmores Limited	35 009 713 437
BD	Biogen Australia Pty Ltd	30 095 760 115
BG	Sandoz Pty Ltd	60 075 449 553
BN	Bayer Australia Ltd	22 000 138 714
BQ	Bristol-Myers Squibb Australia Pty Ltd	33 004 333 322
BX	BAXTER HEALTHCARE PTY LTD	43 000 392 781
BY	Boehringer Ingelheim Pty Ltd	52 000 452 308
BZ	Boucher & Muir Pty Ltd	58 000 140 474
CR	Pharmacor Pty Limited	58 121 020 835
CS	Seqirus (Australia) Pty Ltd	66 120 398 067
CX	Contact Lens Centre Australia Limited	42 092 190 040
DE	Stallergenes Australia Pty Ltd	17 151 366 540
DU	Douglas Pharmaceuticals Australia Pty Limited	61 612 164 824
DV	Medical Developments International Limited	14 106 340 667
DX	Ascensia Diabetes Care Australia Pty Limited	62 607 554 325
DZ	Medsurge Healthcare Pty Ltd	92 124 728 892
EI	Eisai Australia Pty Ltd	73 117 970 993
EJ	Encapsulate Pharma Pty Ltd	80 640 718 289
EO	Ego Pharmaceuticals Pty Ltd	86 005 142 361
EU	Chiesi Australia Pty Ltd	72 145 180 865
EV	Teva Pharma Australia Pty Ltd	41 169 715 664
EW	Celltrion Healthcare Australia Pty Ltd	66 625 407 105
FB	Pierre Fabre Australia Pty Ltd	30 098 999 850
FD	Dr Falk Pharma Australia Pty Ltd	40 631 091 131
FF	Phebra Pty Ltd	99 059 357 890
FG	Phebra Pty Ltd	99 059 357 890
FJ	Pharmaco (Australia) Limited	89 113 383 501
FK	A.Menarini Australia Pty Limited	62 116 935 758
FP	Ferring Pharmaceuticals Pty Limited	87 003 037 170
FQ	Pharmaco (Australia) Limited	89 113 383 501
FT	AMICUS THERAPEUTICS PTY LTD	87 621 776 476
FW	NEURAXPHARM AUSTRALIA PTY LIMITED	86 680 322 392
FX	Gedeon Richter Australia Pty Ltd	98 602 550 274
FY	Pharmacor Pty Limited	58 121 020 835
FZ	Pfizer Australia Pty Ltd	50 008 422 348
GA	Galderma Australia Pty Ltd	12 003 976 930
GC	GlaxoSmithKline Australia Pty Ltd	47 100 162 481
GH	Amdipharm Mercury (Australia) Pty Limited	91 118 106 684
GI	Gilead Sciences Pty Limited	71 072 611 708
GJ	HALEON AUSTRALIA PTY LTD	68 603 310 292
GK	GlaxoSmithKline Australia Pty Ltd	47 100 162 481
GO	Viatris Pty Ltd	29 601 608 771
GQ	Generic Health Pty Ltd	93 110 617 859
GT	Viatris Pty Ltd	29 601 608 771
GX	Apotex Pty Ltd	52 096 916 148
GZ	sanofi-aventis Australia Pty Ltd	31 008 558 807
HB	Besins Healthcare Australia Pty Ltd	68 164 882 062
HJ	Maple Healthcare Pty Ltd	28 646 585 739
HK	SEED PHARMA PTY. LTD.	81 612 154 373
HQ	Generic Health Pty Ltd	93 110 617 859
HT	BTC Speciality Health Pty Ltd	28 621 706 929
HW	HAMELN PHARMA PTY. LTD.	69 638 348 580
HX	Sandoz Pty Ltd	60 075 449 553
IE	BEONE MEDICINES AUS PTY LTD	23 164 802 037
IL	iNova Pharmaceuticals (Australia) Pty Limited	13 617 871 539
IM	iNova Pharmaceuticals (Australia) Pty Limited	13 617 871 539
IO	BioMarin Pharmaceutical Australia Pty Ltd	69 159 743 496
IQ	Alcon Laboratories (Australia) Pty Ltd	88 000 740 830
IR	Indivior Pty Ltd	22 169 280 102
IS	Ipsen Pty Ltd	47 095 036 909
IT	InterPharma Pty Ltd	19 099 877 899
IU	AUPHARMA PTY LTD	84 132 146 313
IX	Clinect Pty Ltd	76 150 558 473
IY	Clinect Pty Ltd	76 150 558 473
JA	JAZZ PHARMACEUTICALS ANZ PTY LTD	83 643 560 534
JC	Janssen-Cilag Pty Ltd	47 000 129 975
JG	Merck Healthcare Pty Ltd	72 006 900 830
JM	Glenmark Pharmaceuticals (Australia) Pty Ltd	23 116 922 500
JO	Juno Pharmaceuticals Pty Ltd	55 156 303 650
JT	Johnson & Johnson Pacific Pty Limited	73 001 121 446
JU	Juno Pharmaceuticals Pty Ltd	55 156 303 650
JW	Asteri Pharma Pty Ltd	69 665 948 158
JX	Juno Pharmaceuticals Pty Ltd	55 156 303 650
KF	BIOCELECT PTY LTD	88 168 092 171
KO	KYOWA KIRIN AUSTRALIA PTY LTD	47 631 934 453
KP	Eli Lilly Australia Pty Ltd	39 000 233 992
KQ	PHERO PHARMA PTY LTD	96 673 730 231
KS	KSJ GROUP PTY LTD	59 166 252 973
KT	ACTOR PHARMACEUTICALS PTY LTD	69 151 192 602
KY	Key Pharmaceuticals Pty Ltd	21 001 215 130
LD	Lacuna Pharma Pty Ltd	12 646 520 792
LJ	Anthia Life Sciences Pty Ltd	99 679 715 863
LL	Astellas Pharma Australia Pty Ltd	81 147 915 482
LM	Link Medical Products Pty Ltd	73 010 971 516
LN	Aspen Pharmacare Australia Pty Limited	51 096 236 985
LO	Leo Pharma Pty Ltd	72 147 880 617
LQ	Astellas Pharma Australia Pty Ltd	81 147 915 482
LR	Cipla Australia Pty Ltd	46 132 155 063
LT	Aspen Pharmacare Australia Pty Limited	51 096 236 985
LU	Lundbeck Australia Pty Ltd	86 070 094 290
LX	Lawley Pharmaceuticals Pty Ltd	12 095 973 523
LY	Eli Lilly Australia Pty Ltd	39 000 233 992
MF	Mundipharma Pty Limited	87 081 322 509
MK	Merck Sharp & Dohme (Australia) Pty Ltd	14 000 173 508
MQ	Alphapharm Pty Ltd	93 002 359 739
MW	Biomed Aust Pty Limited	67 080 084 377
NB	Nova Pharmaceuticals Australasia Pty Ltd	87 104 838 440
NE	Norgine Pty. Ltd.	78 005 022 882
NF	Novo Nordisk Pharmaceuticals Pty. Limited	40 002 879 996
NG	NEON HEALTHCARE PTY LIMITED	57 670 586 526
NM	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
NO	Novo Nordisk Pharmaceuticals Pty. Limited	40 002 879 996
NP	NICE-PAK PRODUCTS PTY. LTD.	71 051 956 346
NQ	Takeda Pharmaceuticals Australia Pty. Ltd.	71 095 610 870
NT	Nestle Australia Ltd	77 000 011 316
NU	Nutricia Australia Pty Limited	99 076 246 752
NV	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
OC	Accord Healthcare Pty. Ltd.	49 110 502 513
OD	Accord Healthcare Pty. Ltd.	49 110 502 513
OH	Orpharma Pty Ltd	19 157 901 267
OJ	The Trustee for ORSPEC PHARMA UNIT TRUST	15 634 980 417
ON	Orion Laboratories Pty. Ltd.	56 009 293 136
OQ	Organon Pharma Pty Ltd	54 637 107 512
OS	Otsuka Australia Pharmaceutical Pty. Ltd	20 601 768 754
OW	Arrow Pharma Pty Ltd	35 605 909 920
OX	Orion Pharma (Aus) Pty Limited	15 654 099 608
PB	Pharmaco (Australia) Limited	89 113 383 501
PF	Pfizer Australia Pty Ltd	50 008 422 348
PK	Fresenius Kabi Australia Pty Limited	39 109 383 593
PP	Petrus Pharmaceuticals Pty Ltd	21 108 884 126
QH	Cortex Health Pty Ltd	17 144 062 386
QS	Sandoz Pty Ltd	60 075 449 553
QY	Pro Pharmaceuticals Group Pty. Ltd.	20 605 457 430
RA	Sun Pharma ANZ Pty Ltd	17 110 871 826
RF	Arrow Pharma Pty Ltd	35 605 909 920
RI	Dr Reddy's Laboratories (Australia) Pty Ltd	16 120 092 408
RJ	Recordati Rare Diseases Australia Pty. Ltd.	26 627 263 094
RN	Sun Pharma ANZ Pty Ltd	17 110 871 826
RO	Roche Products Pty Ltd	70 000 132 865
RQ	Reach Pharmaceuticals Pty Ltd	25 623 897 183
RW	Arrow Pharma Pty Ltd	35 605 909 920
RX	Servier Laboratories (Aust.) Pty. Ltd.	54 004 838 500
RZ	Dr Reddy's Laboratories (Australia) Pty Ltd	16 120 092 408
SA	SciGen (Australia) Pty Limited	76 055 016 969
SB	Nutricia Australia Pty Limited	99 076 246 752
SE	Servier Laboratories (Aust.) Pty. Ltd.	54 004 838 500
SG	Merck Healthcare Pty Ltd	72 006 900 830
SI	Sigma Company Limited	44 004 132 923
SN	Smith & Nephew Pty Limited	68 000 087 507
SW	sanofi-aventis Australia Pty Ltd	31 008 558 807
SY	Bayer Australia Ltd	22 000 138 714
SZ	Sandoz Pty Ltd	60 075 449 553
TB	Teva Pharma Australia Pty Ltd	41 169 715 664
TD	STADA Pharmaceuticals Australia Pty Limited	73 154 966 944
TG	ANTENGENE (AUS) PTY. LTD.	30 638 038 990
TJ	Taiho Pharma Oceania Pty Ltd	97 675 212 530
TK	Takeda Pharmaceuticals Australia Pty. Ltd.	71 095 610 870
TN	Medtas Pty Ltd	72 644 270 860
TQ	Terumo BCT Australia Pty Limited	87 130 046 865
TS	Specialised Therapeutics Australia Pty Ltd	73 124 031 241
TT	Theramex Australia Pty Ltd	37 623 186 845
TW	Apotex Pty Ltd	52 096 916 148
TX	Apotex Pty Ltd	52 096 916 148
TY	Apotex Pty Ltd	52 096 916 148
UC	UCB Australia Proprietary Limited	48 005 799 208
UI	PERRIGO AUSTRALIA PTY LIMITED	15 141 623 403
UL	Bausch & Lomb (Australia) Pty Ltd	88 000 222 408
UO	Bausch & Lomb (Australia) Pty Ltd	88 000 222 408
UR	Camurus Pty Ltd	79 627 784 605
VB	AbbVie Pty Ltd	48 156 384 262
VE	AbbVie Pty Ltd	48 156 384 262
VF	Vitaflo Australia Pty Limited	82 097 161 254
VI	ViiV Healthcare Pty Ltd	46 138 687 448
VJ	VITALION PTY LTD	33 677 876 014
VK	CSL BEHRING (AUSTRALIA) PTY LTD	48 160 734 761
VM	MSN LABORATORIES AUSTRALIA PTY LTD	78 686 372 716
VQ	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
VR	Vertex Pharmaceuticals (Australia) Pty. Ltd.	34 160 157 157
VZ	Sanofi-aventis Healthcare Pty Ltd	43 076 651 959
WA	sanofi-aventis Australia Pty Ltd	31 008 558 807
WG	WAGNER PHARMACEUTICALS PTY LTD	48 670 339 867
WM	MEDISON PHARMA AUSTRALIA PTY LIMITED	19 659 723 403
WZ	Bridgewest Perth Pharma Pty Ltd	21 663 385 411
XB	Specialised Therapeutics Alim Pty Ltd	61 617 311 127
XC	Southern Cross Pharma Pty Ltd	47 094 447 677
XG	ALGORAERX PTY LTD	13 685 469 738
XH	MS Health Pty Ltd	33 155 182 586
XI	Alexion Pharmaceuticals Australasia Pty Ltd	59 132 343 036
XN	Southern XP Pty Ltd	34 639 505 481
XO	Echo Therapeutics Pty Ltd	92 628 298 699
XT	Arrotex Pharmaceuticals Pty Ltd	30 605 552 234
XW	Arrotex Pharmaceuticals Pty Ltd	30 605 552 234
XY	MAXX PHARMA PTY LTD	33 629 622 224
YG	EUGIA PHARMA (AUSTRALIA) PTY LTD	57 656 083 028
YN	Mayne Pharma International Pty Ltd	88 007 870 984
YO	The Trustee for ORSPEC PHARMA UNIT TRUST	15 634 980 417
YT	Mayne Products Pty Ltd	59 140 866 379
ZB	Specialised Therapeutics Pm Pty Ltd	50 617 311 083
ZE	Seekwell Pty Ltd	91 624 401 618
ZL	Specialised Therapeutics Pharma Pty Ltd	77 609 261 430
ZO	Swedish Orphan Biovitrum Pty Ltd	14 645 396 532
ZS	Strides Pharma Science Pty Ltd	44 635 036 734
ZU	Seekwell Pty Ltd	91 624 401 618

Schedule 4 · Circumstances, purposes, conditions and variations

Note: See sections 13, 15, 16, 19 and 23.

Part 1 · Circumstances, purposes and conditions

1Circumstances, purposes and conditions#

The following table sets out:

(a)circumstances for circumstances codes, for the purposes of section 13 and 23; and

(b)purposes for purposes codes, for the purposes of sections 15 and 16; and

(c)for the purposes of section 19, information relating to how authorisation is obtained when the circumstances or conditions for writing a prescription include an authorisation requirement.

Circumstances Code	Purposes Code	Conditions Code	Listed Drug	Circumstances and Purposes	Authority Requirements (part of Circumstances; or Conditions)
C17311	P17311	CN17311	Somatropin	Short stature and poor body composition due to Prader-Willi syndromeInitial treatmentPatient must have diagnostic results consistent with Prader-Willi syndrome (the condition must be genetically proven). orPatient must have a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist. ANDPatient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified. orPatient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment. orPatient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment. ANDPatient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must not have previously received treatment under the PBS S100 Growth Hormone Program. ANDPatient must not have a chronological age of 18 years or greater.Must be treated by a specialist or consultant physician in paediatric endocrinology. orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND5. (a) Confirmation that the patient has diagnostic results consistent with Prader-Willi syndrome; OR(b) Confirmation that the patient has a clinical diagnosis of Prader-Willi syndrome, confirmed by a clinical geneticist6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with 1 repeat allowed)Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17313	P17313	CN17313	Evolocumab	Familial homozygous hypercholesterolaemiaInitial treatmentThe treatment must be in conjunction with dietary therapy and exercise. ANDThe condition must have been confirmed by genetic testing. orThe condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7. ANDPatient must have an LDL cholesterol level in excess of 1.8 millimoles per litre. ANDPatient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise. orPatient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin. orPatient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information.Must be treated by a specialist physician. orMust be treated by an authorised prescriber in consultation with a specialist physician.The qualifying LDL cholesterol level following at least 12 consecutive weeks of treatment with a statin (unless treatment with a statin is contraindicated or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old.A clinically important product-related adverse event is defined as follows:(i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or(ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or(iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.The following must be documented in the patient's medical records:(i) the qualifying Dutch Lipid Clinic Network Score; or(ii) the result of genetic testing confirming a diagnosis of familial homozygous hypercholesterolaemiaOne of the following must be documented in the patient's medical records regarding prior statin treatment:(i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or(ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or(iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information.Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.	Compliance with Authority Required procedures - Streamlined Authority Code 17313
C17316	P17316	CN17316	Acitretin	Severe intractable psoriasisMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17316
C17320	P17320	CN17320	NintedanibPirfenidone	Idiopathic pulmonary fibrosisInitial treatment 1 - new patientThe condition must be diagnosed through a multidisciplinary team. ANDPatient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months. ANDPatient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height. ANDPatient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7. ANDPatient must not have had an acute respiratory infection at the time of FVC measurement. ANDPatient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%. ANDPatient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types. ANDPatient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17323	P17323	CN17323	Rotigotine	Parkinson diseaseThe treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17326	P17326	CN17326	Etanercept	Severe psoriatic arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.An adequate response to treatment is defined as:an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; andeither of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C17328	P17328	CN17328	Tobramycin	Proven Pseudomonas aeruginosa infectionContinuing treatmentThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have cystic fibrosis. ANDPatient must have previously been issued with an authority prescription for tobramycin inhalation capsules. ANDPatient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s).Patient must be 6 years of age or older.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17328
C17329	P17329	CN17329	NintedanibPirfenidone	Idiopathic pulmonary fibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types. ANDPatient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.	Compliance with Authority Required procedures
C17332	P17332	CN17332	Somatropin	Growth retardation secondary to an intracranial lesion, or cranial irradiationRecommencement of treatmentPatient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category. ANDPatient must have had a lapse in growth hormone treatment. ANDThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must be male and must not have a bone age of 15.5 years or more. orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology. orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.Patient must be aged 3 years or older.The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND3. Recent growth data (height and weight, not older than three months); AND4. A bone age result performed within the last 12 months; AND5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17333	P17333	CN17333	Somatropin	Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growthRecommencement of treatment as a reclassified patientPatient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth. ANDPatient must have had a lapse in treatment. ANDThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems. ANDPatient must have a structural lesion that is not neoplastic. orPatient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment). orPatient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion. ANDPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels. orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels. ANDPatient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies). ANDPatient must have hypothalamic obesity. ANDPatient must have had a growth velocity above the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment). orPatient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment. orPatient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must be male and must not have a bone age of 15.5 years or more. orPatient must be female and must not have a bone age of 13.5 years or more.Patient must be aged 3 years or older.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology. orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND7. Confirmation that the patient has hypothalamic obesity; AND8. Recent growth data (height and weight, not older than three months); AND9. A bone age result performed within the last 12 months; AND10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17340	P17340	CN17340	Somatropin	Short stature associated with biochemical growth hormone deficiencyContinuing treatment as a reclassified patientPatient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency. ANDThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems. ANDPatient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological). orPatient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment. orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment). orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment. orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment. ANDPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels. orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must be male and must not have a bone age of 15.5 years or more. orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology. orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics. ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND6. A bone age result performed within the last 12 months; AND7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17349	P17349	CN17349	Tobramycin	Proven Pseudomonas aeruginosa infectionPatient must have cystic fibrosis. ANDThe treatment must be for management.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17349
C17351	P17351	CN17351	Apremilast	Severe chronic plaque psoriasisPatient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug. orPatient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information. orPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate. ANDThe condition must have caused significant interference with quality of life. ANDPatient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) deucravacitinib.Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician. orMust be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar. orMust be treated by a prescriber who is not any of the above, but where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types.Patient must be at least 18 years of age.For patients who do not demonstrate an adequate response to apremilast, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'.This assessment must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17351
C17355	P17355	CN17355	Etanercept	Severe psoriatic arthritisInitial treatment - Initial 1 (new patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months. ANDPatient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months. orPatient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; andeither(a) an active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C17356	P17356	CN17356	Pirfenidone	Idiopathic pulmonary fibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types. ANDPatient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.	Compliance with Authority Required procedures
C17365	P17365	CN17365	Somatropin	Growth retardation secondary to an intracranial lesion, or cranial irradiationContinuing treatmentPatient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category. ANDPatient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must be male and must not have a bone age of 15.5 years or more. orPatient must be female and must not have a bone age of 13.5 years or more.Patient must be aged 3 years or older.The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND4. A bone age result performed within the last 12 months; AND5. The final adult height (in cm) of the patient's mother and father (where available); AND6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17366	P17366	CN17366	Somatropin	Biochemical growth hormone deficiency and precocious pubertyContinuing treatmentPatient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category. ANDPatient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orPatient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must be male and must not have a bone age of 15.5 years or more. orPatient must be female and must not have a bone age of 13.5 years or more.Patient must be aged 3 years or older.The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND4. A bone age result performed within the last 12 months; AND5. The final adult height (in cm) of the patient's mother and father (where available); AND6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17369	P17369	CN17369	Somatropin	Short stature associated with biochemical growth hormone deficiencyInitial treatmentPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency). orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels. orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels. ANDPatient must have a current height at or below the 1st percentile for age and sex. orPatient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child). orPatient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must not have previously received treatment under the PBS S100 Growth Hormone Program. ANDPatient must be male and must not have a bone age of 15.5 years or more. orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a specialist or consultant physician in paediatric endocrinology. orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology. ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex; AND4. A bone age result performed within the last 12 months; AND5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17372	P17372	CN17372	Nintedanib	Progressive fibrosing Interstitial lung diseaseInitial treatmentThe condition must be diagnosed through a multidisciplinary team. ANDThe condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication. ANDThe condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5). ANDPatient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of: (i) age, (ii) gender, (iii) height. ANDThe condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of: (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient's medical records. ANDPatient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7. ANDPatient must not have had an acute respiratory infection at the time of FVC measurement. ANDPatient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that is both: (i) at least 30% predicted, (ii) no greater than 80% predicted. ANDThe condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is). ANDThe condition must not be due to reversible causes (e.g. drug toxicity).Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types. ANDPatient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following: (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.	Compliance with Written Authority Required procedures
C17374	P17374	CN17374	Etanercept	Severe chronic plaque psoriasisFirst continuing treatment, Face, hand, footPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 1 month old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C17380	P17380	CN17380	Somatropin	Short stature associated with Turner syndromeInitial treatmentMust be treated by a specialist or consultant physician in paediatric endocrinology. orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female. orPatient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female. orPatient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring-chromosome, or partial deletion of an X chromosome), and gender of rearing is female. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must not have previously received treatment under the PBS S100 Growth Hormone Program. ANDPatient must not have a height greater than or equal to 155.0 cm. ANDPatient must not have a bone age of 13.5 years or greater.Patient must be aged 3 years or older.The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17381	P17381	CN17381	CefalexinFlucloxacillin	OsteomyelitisMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where this prescription is to continue existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17381
C17387	P17387	CN17387	Dexamethasone	Diabetic macular oedema (DMO)Initial treatmentPatient must have visual impairment due to diabetic macular oedema. ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment. ANDThe condition must be diagnosed by optical coherence tomography. orThe condition must be diagnosed by fluorescein angiography. ANDPatient must have had a cataract removed in the treated eye. orPatient must be scheduled for cataract surgery in the treated eye. ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors. orPatient must be unsuitable for treatment with VEGF inhibitors. orPatient must have failed prior treatment with VEGF inhibitors. ANDThe treatment must be as monotherapy. orThe treatment must be in combination with laser photocoagulation. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Authority approval for initial treatment of each eye must be sought.Details (date, unique identifying number/code or provider number) of one of the following diagnostic reports for each eye must be documented in the patient's medical records:(i) fluorescein angiogram report;(ii) optical coherence tomography report.	Compliance with Authority Required procedures
C17388	P17388	CN17388	Somatropin	Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infantsRecommencement of treatmentPatient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category. ANDPatient must have had a lapse in growth hormone treatment. ANDThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant). orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone. orThe treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems. ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes. ANDPatient must not have an active tumour or evidence of tumour growth or activity. ANDPatient must not have a chronological age of 5 years or greater.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology. orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.Patient must be aged 3 years or older.The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2025 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).The authority application must be in writing and must include:1. Details of the proposed prescription; AND2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND3. Recent growth data (height and weight, not older than three months); AND4. A bone age result performed within the last 12 months; AND5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C17391	P17391	CN17391	Deucravacitinib	Severe chronic plaque psoriasisPatient must not have achieved adequate response after at least 6 weeks of treatment with methotrexate prior to initiating treatment with this drug. orPatient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information. orPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate. ANDThe condition must have caused significant interference with quality of life. ANDPatient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with each of: (i) a biological medicine, (ii) ciclosporin, (iii) apremilast.Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician. orMust be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar. orMust be treated by a prescriber who is not any of the above, but where there is agreement to continue treatment (not initiate treatment) with one of the above practitioner types.Patient must be at least 18 years of age.For patients who do not demonstrate an adequate response to deucravacitinib, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'.This assessment must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17391
C17393	P17393	CN17393	Nintedanib	Progressive fibrosing Interstitial lung diseaseContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types. ANDPatient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. ANDPatient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications: (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.	Compliance with Authority Required procedures
C17395	P17395	CN17395	Ranibizumab	Proliferative diabetic retinopathy (PDR) and/or Diabetic macular oedema (DMO)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDThe treatment must be as monotherapy. orThe treatment must be in combination with laser photocoagulation.Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.	Compliance with Authority Required procedures - Streamlined Authority Code 17395
C17397	P17397	CN17397	Tobramycin	Proven Pseudomonas aeruginosa infectionInitial treatmentPatient must have cystic fibrosis. ANDPatient must have been assessed for bronchial hyperresponsiveness as per the TGA-approved Product Information, with a negative test result. ANDPatient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS-subsidised therapy. The trial commencement date must be documented in the patient's medical records.Patient must be 6 years of age or older.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17397
C17399	P17399	CN17399	Lumasiran	Primary hyperoxaluria type 1Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must continue to demonstrate clinical benefit as assessed by the treating physician. ANDPatient must not have previously undergone liver transplant for primary hyperoxaluria type 1.Must be treated by a nephrologist with experience in the management of hyperoxaluria. orMust be treated by a paediatrician with experience in the management of hyperoxaluria. orMust be treated by an authorised prescriber in consultation with one of the above specialty types.At the time of the authority application, prescribers should request the appropriate number of vials based on the patient's weight, as per the TGA approved Product Information. Up to 1 repeat may be requested for continuing treatment.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17401	P17401	CN17401	Lumasiran	Primary hyperoxaluria type 1Initial treatment - loading doseThe condition must be primary hyperoxaluria type 1 confirmed by genetic testing. ANDPatient must have undergone treatment with pyridoxine therapy. orPatient must have a PH1 allele that is considered not responsive to pyridoxine therapy. orPatient must be contraindicated for pyridoxine therapy as determined by the treating or consulting clinician. ANDPatient must have urinary oxalate greater than or equal to 0.70 mmol/24 h/1.73 m2 measured by mean 24-h urinary oxalate excretion from a valid 24-h urine collection. orPatient must have urinary oxalate: creatinine ratio greater than the upper limit of normal based on age on at least two of three single-void collections during screening. orPatient must have clinical symptoms indicative of hyperoxaluria, such as (i) nephrocalcinosis; (ii) renal stones; (iii) renal impairment; (iv) systemic oxalosis. ANDPatient must not have previously undergone liver transplant for primary hyperoxaluria type 1.Must be treated by a nephrologist with experience in the management of hyperoxaluria. orMust be treated by a paediatrician with experience in the management of hyperoxaluria. orMust be treated by an authorised prescriber in consultation with one of the above specialty types.At the time of the authority application, prescribers should request the appropriate number of vials based on the patient's weight, as per the TGA approved Product Information. Up to 2 repeats may be requested for initial treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17402	P17402	CN17402	Evolocumab	Familial homozygous hypercholesterolaemiaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be in conjunction with dietary therapy and exercise.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17402
C17403	P17403	CN17403	Tobramycin	Proven Pseudomonas aeruginosa infectionThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have cystic fibrosis. ANDThe treatment must be for management.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17403
C17405	P17405	CN17405	Tobramycin	Proven Pseudomonas aeruginosa infectionContinuing treatmentPatient must have cystic fibrosis. ANDPatient must have previously been issued with an authority prescription for tobramycin inhalation capsules. ANDPatient must have demonstrated ability to tolerate the dry powder formulation following the initial 4-week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s).Patient must be 6 years of age or older.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where patient care is being shared with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17405
C17406	P17406	CN17406	Budesonide	Eosinophilic oesophagitisSubsequent continuing treatment - Maintenance of remissionPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction. ANDPatient must have documented evidence of having achieved histologic remission while receiving Initial and First continuing PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16 eosinophils per mm2 hpf on oesophageal biopsy. ANDThe condition must not have progressed while being treated with this drug.Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types.Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient's diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient's eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.The result of the histological assessment must be documented in the patient's medical records.First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.	Compliance with Authority Required procedures
C17409	P17409	CN17409	Budesonide	Eosinophilic oesophagitisFirst continuing treatment - until remission is confirmedPatient must have previously received PBS-subsidised initial treatment with this drug for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug for this condition. ANDPatient must not receive more than 36 weeks of treatment under this restriction.Must be treated by a prescriber who is either: (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis, (iv) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned prescriber types.Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient's diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient's eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.The result of the histological assessment must be documented in the patient's medical records.First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.	Compliance with Authority Required procedures
C17413	P17413	CN17413	Daratumumab	Untreated multiple myelomaContinuing treatment as first line drug therapy from week 25 onwards (administered once every four weeks)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone. ANDPatient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
C17431	P17431	CN17431	Infliximab	Severe chronic plaque psoriasisContinuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous formPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDThe treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where the condition is affecting the whole body, an adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle.Where the condition is affecting the face/hand/foot, an adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) A reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or, sustained at this level, as compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or(ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle.All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 17431
C17434	P17434	CN17434	Infliximab	Moderate to severe ulcerative colitisContinuing treatment with subcutaneous form or switching from intravenous form to subcutaneous formMust be treated by a gastroenterologist (code 87). orMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]. orMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition. orPatient must have received this drug in the intravenous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab intravenous form continuing treatment restriction. ANDPatient must not receive more than 24 weeks of treatment under this restriction. ANDPatient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug. orPatient must have demonstrated an adequate response to treatment with this drug in the intravenous form.Patient must be at least 18 years of age.Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed within 4 weeks prior to completing their current course of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 17434
C17436	P17436	CN17436	Sorafenib	Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 17436
C17437	P17437	CN17437	Durvalumab	Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 17437
C17438	P17438	CN17438	Brentuximab vedotin	Relapsed or Refractory Hodgkin lymphomaInitial treatmentPatient must have undergone a primary autologous stem cell transplant (ASCT). ANDPatient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT. orPatient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT. ANDPatient must not receive more than 4 cycles of treatment under this restriction. ANDPatient must not have received prior treatment with this drug for this condition. orPatient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting.	Compliance with Authority Required procedures
C17440	P17440	CN17440	Brentuximab vedotin	Relapsed or Refractory Hodgkin lymphomaContinuing treatmentPatient must not have undergone an autologous stem cell transplant (ASCT) for this condition. ANDPatient must not be suitable for ASCT for this condition. orPatient must not be suitable for treatment with multi-agent chemotherapy for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. ANDPatient must not receive more than 12 cycles of treatment under this restriction.The treatment must not exceed a total of 16 cycles for this condition in a lifetime.	Compliance with Authority Required procedures
C17444	P17444	CN17444	TiagabineVigabatrinZonisamide	Focal onset seizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17444
C17445	P17445	CN17445	GabapentinTiagabineVigabatrinZonisamide	Focal onset seizuresThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17445
C17446	P17446	CN17446	Lamotrigine	Epileptic seizuresMust be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C17449	P17449	CN17449	Everolimus	Refractory seizures associated with tuberous sclerosis complexInitial treatmentPatient must have a confirmed diagnosis of tuberous sclerosis complex (TSC). ANDPatient must be experiencing a minimum of two partial-onset seizures per week. ANDThe condition must have failed to be controlled satisfactorily at stable doses of at least two antiseizure medications. ANDThe treatment must be in combination with at least one antiseizure medication. ANDPatient must not be a candidate for curative surgery.Patient must be at least 2 years of age.	Compliance with Authority Required procedures
C17451	P17451	CN17451	Brivaracetam	Intractable focal onset seizuresInitial treatmentMust be treated by a neurologist.The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent. ANDThe condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents. ANDThe treatment must not be given concomitantly with levetiracetam, except for cross titration.	Compliance with Authority Required procedures - Streamlined Authority Code 17451
C17452	P17452	CN17452	Brivaracetam	Intractable focal onset seizuresContinuing treatmentPatient must have previously been treated with PBS-subsidised treatment with this drug for this condition. ANDThe treatment must not be given concomitantly with levetiracetam.	Compliance with Authority Required procedures - Streamlined Authority Code 17452
C17455	P17455	CN17455	Lacosamide	Intractable focal onset seizuresContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 17455
C17456	P17456	CN17456	Stiripentol	Severe myoclonic epilepsy in infancy (Dravet syndrome)Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications. ANDThe treatment must be as adjunctive therapy to at least two other antiseizure medications.Must be treated by a neurologist if treatment is being initiated. orMust be treated by a neurologist if treatment is being continued or re-initiated. orMust be treated by a paediatrician in consultation with a neurologist if treatment is being continued. orMust be treated by a general practitioner in consultation with a neurologist if treatment is being continued.	Compliance with Authority Required procedures - Streamlined Authority Code 17456
C17457	P17457	CN17457	Fenfluramine	Severe myoclonic epilepsy in infancy (Dravet syndrome)Patient must have (if initiating) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications. orPatient must have had (if continuing) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications. ANDThe treatment must be as adjunctive therapy to at least two other antiseizure medications.Must be treated by a neurologist if treatment is being initiated. orMust be treated by a neurologist if treatment is being continued or re-initiated. orMust be treated by a paediatrician in consultation with a neurologist if treatment is being continued. orMust be treated by a general practitioner in consultation with a neurologist if treatment is being continued.	Compliance with Authority Required procedures
C17460	P17460	CN17460	Levetiracetam	Epileptic seizuresThe treatment must not be given concomitantly with brivaracetam, except for cross titration.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C17477	P17477	CN17477	Tremelimumab	Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaInitial treatmentPatient must be undergoing combination treatment with PBS-subsidised durvalumab. ANDPatient must have a WHO performance status of 0 or 1. ANDPatient must not be suitable for transarterial chemoembolisation. ANDPatient must have Child Pugh class A. ANDThe condition must be untreated with systemic therapy. orPatient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).Patient must not be undergoing PBS-subsidised treatment with this drug for this indication more than once per lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 17477
C17478	P17478	CN17478	Oxcarbazepine	SeizuresPatient must have focal onset seizures. orPatient must have primary generalised tonic-clonic seizures. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17478
C17481	P17481	CN17481	Perampanel	Intractable focal onset seizuresContinuing treatmentThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have previously been issued with an authority prescription for this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 17481
C17487	P17487	CN17487	Topiramate	SeizuresPatient must have focal onset seizures. orPatient must have primary generalised tonic-clonic seizures. orPatient must have seizures of the Lennox-Gastaut syndrome. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17487
C17488	P17488	CN17488	Topiramate	SeizuresPatient must have focal onset seizures. orPatient must have primary generalised tonic-clonic seizures. orPatient must have seizures of the Lennox-Gastaut syndrome. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication. ANDPatient must be unable to take a solid dose form of topiramate.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17488
C17491	P17491	CN17491	Daratumumab	Relapsed and/or refractory multiple myelomaInitial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly)The condition must be confirmed by a histological diagnosis. ANDThe treatment must be in combination with bortezomib and dexamethasone. ANDPatient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised).Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), or irrespective of whether the disease staging has been changed (i.e. disease has changed from untreated multiple myeloma to relapsed or refractory multiple myeloma), (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner.A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease.	Compliance with Authority Required procedures
C17498	P17498	CN17498	Obeticholic acid	Primary biliary cholangitis (previously known as Primary biliary cirrhosis)Initial treatmentMust be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist. orMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types. ANDPatient must be undergoing concurrent treatment with ursodeoxycholic acid. orPatient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated. ANDPatient must not be undergoing concurrent treatment with elafibranor.Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug. orPatient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug. ANDPatient must not have/be each of: (i) severe liver disease, (ii) immunocompromised. ANDPatient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks. orPatient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks. orPatient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid. orPatient must have experienced an intolerance to elafibranor of a severity requiring treatment discontinuation, prior to initiating treatment with this drug. orPatient must have inadequately responded to treatment with elafibranor, prior to initiating treatment with this drug.Patient must be at least 18 years of age.Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.	Compliance with Authority Required procedures
C17499	P17499	CN17499	Elafibranor	Primary biliary cholangitis (previously known as Primary biliary cirrhosis)Initial treatmentMust be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist. orMust be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types. ANDPatient must be undergoing concurrent treatment with ursodeoxycholic acid. orPatient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated. ANDPatient must not be undergoing concurrent treatment with obeticholic acid.Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug. orPatient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug. ANDPatient must not have/be each of: (i) severe liver disease, (ii) immunocompromised. ANDPatient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks. orPatient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks. orPatient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid. orPatient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug. orPatient must have inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug.Patient must be at least 18 years of age.Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.	Compliance with Authority Required procedures
C17501	P17501	CN17501	Elafibranor	Primary biliary cholangitis (previously known as Primary biliary cirrhosis)Continuing treatmentMust be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist. orMust be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types. ANDPatient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the 'Initial treatment' listing, (ii) 'Grandfather' arrangements. ANDPatient must be undergoing concurrent treatment with ursodeoxycholic acid. orPatient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated. ANDPatient must not be undergoing concurrent treatment with obeticholic acid.Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.The improvement in the qualifying laboratory reading(s) has/have been documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17501
C17502	P17502	CN17502	Infliximab	Ankylosing spondylitisContinuing treatment with subcutaneous form or switching from intravenous form to subcutaneous formPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDThe treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:(a) an ESR measurement no greater than 25 mm per hour; or(b) a CRP measurement no greater than 10 mg per L; or(c) an ESR or CRP measurement reduced by at least 20% from baseline.Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 17502
C17504	P17504	CN17504	Sorafenib	Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaInitial treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have Child Pugh class A. ANDThe condition must be untreated with systemic therapy. orPatient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy, (iii) durvalumab/tremelimumab combination therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 17504
C17505	P17505	CN17505	Durvalumab	Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaInitial treatmentPatient must be undergoing combination treatment with tremelimumab for the first dose of treatment. ANDPatient must have a WHO performance status of 0 or 1. ANDPatient must not be suitable for transarterial chemoembolisation. ANDPatient must have Child Pugh class A. ANDThe condition must be untreated with systemic therapy. orPatient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).	Compliance with Authority Required procedures - Streamlined Authority Code 17505
C17507	P17507	CN17507	Brentuximab vedotin	Relapsed or Refractory Hodgkin lymphomaContinuing treatmentPatient must have undergone a primary autologous stem cell transplant (ASCT) for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. ANDPatient must not receive more than 12 cycles of treatment under this restriction.The treatment must not exceed a total of 16 cycles for this condition in a lifetime.	Compliance with Authority Required procedures
C17508	P17508	CN17508	Brentuximab vedotin	Relapsed or Refractory Hodgkin lymphomaInitial treatmentPatient must not have undergone an autologous stem cell transplant (ASCT) for this condition. ANDPatient must not be suitable for ASCT for this condition. orPatient must not be suitable for treatment with multi-agent chemotherapy for this condition. ANDPatient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition. orPatient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition. ANDPatient must not receive more than 4 cycles of treatment under this restriction. ANDPatient must not have received prior treatment with this drug for this condition. orPatient must not have failed PBS-subsidised treatment with this drug for this condition in the first-line setting.	Compliance with Authority Required procedures
C17509	P17509	CN17509	Oxcarbazepine	SeizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have focal onset seizures. orPatient must have primary generalised tonic-clonic seizures. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17509
C17512	P17512	CN17512	Lamotrigine	Epileptic seizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C17513	P17513	CN17513	Lacosamide	Idiopathic generalised epilepsy with primary generalised tonic-clonic seizuresMust be treated by a neurologist. orMust be treated by a paediatrician. orMust be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced. ANDThe treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised antiseizure medication at the time the drug is/was first commenced.	Compliance with Authority Required procedures - Streamlined Authority Code 17513
C17515	P17515	CN17515	Lacosamide	Idiopathic generalised epilepsy with primary generalised tonic-clonic seizuresDose titration at the start of therapy, during therapy or to gradually cease treatmentMust be treated by a neurologist. orMust be treated by a paediatrician.The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced. ANDThe treatment must be (for initiating treatment)/have been (for continuing treatment) in combination with at least one PBS-subsidised antiseizure medication at the time the drug is/was first commenced. ANDThe treatment must be for dose titration purposes.	Compliance with Authority Required procedures - Streamlined Authority Code 17515
C17516	P17516	CN17516	Lacosamide	Idiopathic generalised epilepsy with primary generalised tonic-clonic seizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.Must be treated by a neurologist. orMust be treated by a paediatrician. orMust be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.The condition must have failed to be controlled satisfactorily by at least two antiseizure medications prior to when the drug is/was first commenced. ANDThe treatment must have been in combination with at least one PBS-subsidised antiseizure medication at the time the drug was first commenced.	Compliance with Authority Required procedures - Streamlined Authority Code 17516
C17517	P17517	CN17517	Perampanel	Intractable focal onset seizuresContinuing treatmentPatient must have previously been issued with an authority prescription for this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 17517
C17520	P17520	CN17520	Lacosamide	Intractable focal onset seizuresInitial treatmentMust be treated by a neurologist.The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent. ANDThe condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents.	Compliance with Authority Required procedures - Streamlined Authority Code 17520
C17521	P17521	CN17521	Cannabidiol	Severe myoclonic epilepsy in infancy (Dravet syndrome)Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other antiseizure medications. ANDThe treatment must be as adjunctive therapy to at least two other antiseizure medications.Must be treated by a neurologist if treatment is being initiated. orMust be treated by a neurologist if treatment is being continued or re-initiated. orMust be treated by a paediatrician in consultation with a neurologist if treatment is being continued. orMust be treated by a general practitioner in consultation with a neurologist if treatment is being continued.	Compliance with Authority Required procedures
C17525	P17525	CN17525	Topiramate	SeizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have focal onset seizures. orPatient must have primary generalised tonic-clonic seizures. orPatient must have seizures of the Lennox-Gastaut syndrome. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication. ANDPatient must be unable to take a solid dose form of topiramate.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17525
C17531	P17531	CN17531	Infliximab	Severe psoriatic arthritisContinuing treatment with subcutaneous form or switching from intravenous form to subcutaneous formMust be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDThe treatment must have both: (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; andeither of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 17531
C17539	P17539	CN17539	Everolimus	Refractory seizures associated with tuberous sclerosis complexContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have maintained a response to the PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be in combination with at least one antiseizure medication. ANDPatient must not be a candidate for curative surgery.	Compliance with Authority Required procedures - Streamlined Authority Code 17539
C17540	P17540	CN17540	Brivaracetam	Intractable focal onset seizuresContinuing treatmentPatient must have previously been treated with PBS-subsidised treatment with this drug for this condition. ANDPatient must be unable to take a solid dose form of this drug. ANDThe treatment must not be given concomitantly with levetiracetam.	Compliance with Authority Required procedures - Streamlined Authority Code 17540
C17541	P17541	CN17541	Lacosamide	Intractable focal onset seizuresInitial treatmentMust be treated by a neurologist.The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent. ANDThe condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents. ANDThe treatment must be for dose titration purposes.	Compliance with Authority Required procedures - Streamlined Authority Code 17541
C17543	P17543	CN17543	Levetiracetam	Epileptic seizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDThe treatment must not be given concomitantly with brivaracetam, except for cross titration.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C17548	P17548	CN17548	Obeticholic acid	Primary biliary cholangitis (previously known as Primary biliary cirrhosis)Continuing treatmentMust be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist. orMust be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types. ANDPatient must be undergoing continuing PBS-subsidised treatment with this drug, with treatment having commenced through one of: (i) the 'Initial treatment' listing, (ii) 'Grandfather' arrangements. ANDPatient must be undergoing concurrent treatment with ursodeoxycholic acid. orPatient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated. ANDPatient must not be undergoing concurrent treatment with elafibranor.Patient must have achieved an adequate response to this drug, defined as having at least one of: (i) an alkaline phosphate (ALP) level less than 1.67 times the upper limit of normal (ULN), (ii) a reduction in the ALP reading of at least 15% compared to the baseline level provided with the initial authority application, (iii) a total bilirubin level within the normal reference range.The improvement in the qualifying laboratory reading(s) has/have been documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17548
C17549	P17549	CN17549	Infliximab	Severe active rheumatoid arthritisBalance of supply for Initial treatment - subcutaneous formMust be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive). ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. ANDThe treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form.Patient must be at least 18 years of age.	Compliance with Authority Required procedures
C17551	P17551	CN17551	Infliximab	Severe active rheumatoid arthritisContinuing treatment with subcutaneous form or switching from intravenous form to subcutaneous formMust be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. orPatient must have demonstrated an adequate response to treatment with this drug in the intravenous form. ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 17551
C17552	P17552	CN17552	Infliximab	Moderate to severe ulcerative colitisBalance of supply for Initial treatment - subcutaneous formMust be treated by a gastroenterologist (code 87). orMust be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]. orMust be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive). ANDThe treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form.Patient must be at least 18 years of age.	Compliance with Authority Required procedures
C17560	P17560	CN17560	Lacosamide	Intractable focal onset seizuresContinuing treatmentThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 17560
C17561	P17561	CN17561	Brivaracetam	Intractable focal onset seizuresInitial treatmentMust be treated by a neurologist.The treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent. ANDThe condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents. ANDPatient must be unable to take a solid dose form of this drug. ANDThe treatment must not be given concomitantly with levetiracetam, except for cross titration.	Compliance with Authority Required procedures - Streamlined Authority Code 17561
C17562	P17562	CN17562	Topiramate	SeizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have focal onset seizures. orPatient must have primary generalised tonic-clonic seizures. orPatient must have seizures of the Lennox-Gastaut syndrome. ANDThe condition must have failed to be controlled satisfactorily by at least one other antiseizure medication.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17562
C17563	P17563	CN17563	Levetiracetam	Epileptic seizuresPatient must be unable to take a solid dose form of levetiracetam. ANDThe treatment must not be given concomitantly with brivaracetam, except for cross titration.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C17564	P17564	CN17564	Levetiracetam	Epileptic seizuresThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must be unable to take a solid dose form of levetiracetam. ANDThe treatment must not be given concomitantly with brivaracetam, except for cross titration.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C17567	P17567	CN17567	Elafibranor	Primary biliary cholangitis (previously known as Primary biliary cirrhosis)Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangementsPatient must have received treatment with this drug for this PBS indication prior to 1 November 2025.Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist. orMust be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types. ANDPatient must be undergoing concurrent treatment with ursodeoxycholic acid. orPatient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated. ANDPatient must not be undergoing concurrent treatment with obeticholic acid.Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug. orPatient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug. ANDPatient must not have/be each of: (i) severe liver disease, (ii) immunocompromised. ANDPatient must have had, prior to initiating treatment with this drug, an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks. orPatient must have had, prior to initiating treatment with this drug, a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks. orPatient must have had, prior to initiating treatment with this drug, abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid. orPatient must have experienced an intolerance to obeticholic acid of a severity requiring treatment discontinuation, prior to initiating treatment with this drug. orPatient must have had inadequately responded to treatment with obeticholic acid, prior to initiating treatment with this drug.Patient must be at least 18 years of age.Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.	Compliance with Authority Required procedures
C17570	P17570	CN17570	Perampanel	Idiopathic generalised epilepsy with primary generalised tonic-clonic seizuresInitial treatmentMust be treated by a neurologist.The condition must have failed to be controlled satisfactorily by at least two antiseizure medications. ANDThe treatment must be in combination with at least one PBS-subsidised antiseizure medication.Patient must be aged 12 years or older.	Compliance with Authority Required procedures - Streamlined Authority Code 17570
C17573	P17573	CN17573	Capivasertib	Locally advanced or metastatic breast cancerThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be estrogen receptor positive. ANDThe treatment must be in combination with fulvestrant. ANDThe treatment must be following progression on at least one endocrine-based regimen in the metastatic setting. orThe treatment must be following recurrence on or within 12 months of completing endocrine-based adjuvant therapy.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:1) Evidence of HER2 negative status (evidence obtained in relation to past PBS treatment is acceptable).2) Evidence of HR status.	Compliance with Authority Required procedures
C17577	P17577	CN17577	Perampanel	Intractable focal onset seizuresInitial treatmentThe treatment must be in combination with two or more antiseizure medications which include one second-line adjunctive agent. ANDThe condition must have failed to be controlled satisfactorily by other antiseizure medications, which include at least one first-line antiseizure agent and at least two second-line adjunctive antiseizure agents.Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 17577
C17585	P17585	CN17585	Bimekizumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 1 (new patient)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition. orPatient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. orPatient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count; and(iii) the name of the antibiotic/s received for two separate courses each of three months; or(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C17587	P17587	CN17587	Adalimumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17590	P17590	CN17590	Secukinumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The details of two proposed prescriptions should be submitted with every initial application for this drug.Prescribing the 150 mg presentation:One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.Prescribing the 300 mg presentation:One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.	Compliance with Written Authority Required procedures
C17591	P17591	CN17591	Bimekizumab	Moderate to severe hidradenitis suppurativaTransitioning from non-PBS to PBS-subsidised supply - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 December 2025. ANDPatient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug for this condition. ANDPatient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer. ANDPatient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition. orPatient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition. orPatient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of non-PBS-subsidised treatment with this drug for this condition. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a dermatologist.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Assessment of disease severity must not have been more than 4 weeks old at the time treatment with this drug was initiated.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count; and(iii) the name of the antibiotic/s received; or(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal. The name of the one course of antibiotics must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal.(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).A patient may qualify for PBS-subsidised treatment under this restriction once only.For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Written Authority Required procedures
C17594	P17594	CN17594	Secukinumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition. ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The details of two proposed prescriptions should be submitted with every initial application for this drug.Prescribing the 150 mg presentation:One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.Prescribing the 300 mg presentation:One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.	Compliance with Written Authority Required procedures
C17595	P17595	CN17595	Bimekizumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C17596	P17596	CN17596	Bimekizumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C17603	P17603	CN17603	Iptacopan	Paroxysmal nocturnal haemoglobinuria (PNH)Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025. ANDPatient must have a documented PNH granulocyte clone size equal to or greater than 10% within the 3 months prior to initiating non-PBS-subsidised treatment with this drug. ANDPatient must have experienced an inadequate response to a complement 5 (C5) inhibitor demonstrated by a haemoglobin level of less than 105 g/L prior to initiating non-PBS-subsidised treatment with this drug. orPatient must be intolerant to C5 inhibitors as determined by the treating physician prior to initiating non-PBS-subsidised treatment with this drug. ANDPatient must have been receiving treatment with at least one C5 inhibitor for at least 3 months prior to initiating non-PBS-subsidised treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have experienced clinical improvement as a result of treatment with this drug. orPatient must have experienced a stabilisation of the condition as a result of treatment with this drug.Must be treated by a haematologist. orMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x109/L)(iii) White Cell Count (x109/L)(iv) Reticulocytes (x109/L)(v) Neutrophils (x109/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH: ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
C17611	P17611	CN17611	Cabozantinib	Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET)Initial treatmentPatient must not have received prior PBS-subsidised treatment with this drug for this condition. ANDPatient must have progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) following at least one prior systemic therapy other than a somatostatin analogue for this indication prior to initiating treatment with this drug. ANDPatient must have had a WHO performance status score of no greater than 2 at treatment initiation with this drug.Patient must not be undergoing treatment with this drug more than once per lifetime.Patients who develop disease progression while receiving PBS-subsidised treatment with cabozantinib for this condition are not eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.Patients who develop intolerance while receiving PBS-subsidised treatment with cabozantinib are eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.Disease progression must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17611
C17614	P17614	CN17614	Sunitinib	Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)Initial treatmentPatient must be symptomatic (despite somatostatin analogues). orPatient must have disease progression. ANDThe treatment must be as monotherapy.Disease progression must be documented in the patient's medical records.Patients who have developed progressive disease with any of: (i) everolimus; (ii) cabozantinib are not eligible to receive PBS-subsidised treatment with sunitinib for this condition.Patients who have developed intolerance with any of: (i) everolimus; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.	Compliance with Authority Required procedures
C17616	P17616	CN17616	Toripalimab	Recurrent or metastatic nasopharyngeal carcinomaPatient must have a WHO performance status of no higher than 2. ANDThe condition must not be amenable to salvage surgery or radiotherapy. ANDPatient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition. ANDThe treatment must be commenced in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting (i.e. used in combination with PBC for 6 cycles in the first line setting unless intolerance/contraindication is confirmed). orThe treatment must be the sole PBS-subsidised therapy at the time of treatment initiation where the condition has progressed following treatment with PBC (i.e. used as monotherapy in the second line setting).Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 cumulative months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.	Compliance with Authority Required procedures - Streamlined Authority Code 17616
C17617	P17617	CN17617	Adalimumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17620	P17620	CN17620	Adalimumab	Moderate to severe hidradenitis suppurativaFirst continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated a response to treatment with this drug for this condition.Must be treated by a dermatologist.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17634	P17634	CN17634	Octreotide	Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe condition must be unresectable locally advanced disease or metastatic disease. ANDThe condition must be World Health Organisation (WHO) grade 1 or 2. ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17634
C17635	P17635	CN17635	LanreotideOctreotide	Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease. ANDThe condition must be World Health Organisation (WHO) grade 1 or 2. ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17635
C17636	P17636	CN17636	Cabozantinib	Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) or extra-pancreatic neuroendocrine tumour (epNET)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Patient must not be undergoing treatment with this drug more than once per lifetime.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.Patients who develop disease progression while receiving PBS-subsidised treatment with cabozantinib for this condition are not eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.Patients who develop intolerance while receiving PBS-subsidised treatment with cabozantinib are eligible to receive subsequent PBS-subsidised treatment with any of: (i) sunitinib, (ii) everolimus.	Compliance with Authority Required procedures - Streamlined Authority Code 17636
C17637	P17637	CN17637	LanreotideOctreotide	Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)The condition must be unresectable locally advanced disease or metastatic disease. ANDThe condition must be World Health Organisation (WHO) grade 1 or 2. ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17637
C17638	P17638	CN17638	Lanreotide	Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Initial treatmentMust be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist. orMust be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.The condition must be unresectable locally advanced disease or metastatic disease. ANDThe condition must be World Health Organisation (WHO) grade 1 or 2. ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17638
C17643	P17643	CN17643	Bimekizumab	Moderate to severe hidradenitis suppurativaInitial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years), or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment. orPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment. orPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment. ANDThe treatment must provide no more than the balance of up to 16 weeks treatment.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C17644	P17644	CN17644	Secukinumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 1 (new patient)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition. orPatient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. orPatient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count; and(iii) the name of the antibiotic/s received for two separate courses each of three months; or(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).This restriction is intended for induction dosing only.The details of two proposed prescriptions should be submitted with every initial application for this drug.Prescribing the 150 mg presentation:One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.Prescribing the 300 mg presentation:One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C17646	P17646	CN17646	Bimekizumab	Moderate to severe hidradenitis suppurativaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated a response to treatment with this drug for this condition.Must be treated by a dermatologist.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17660	P17660	CN17660	Daratumumab	Untreated multiple myelomaInitial treatment as first-line drug therapy from week 0 to week 24The condition must be newly diagnosed. ANDThe condition must be confirmed by a histological diagnosis. ANDPatient must be ineligible for a primary stem cell transplantation. ANDThe treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone. ANDPatient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide.Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.	Compliance with Authority Required procedures
C17661	P17661	CN17661	Daratumumab	Untreated multiple myelomaTransitioning from non-PBS to PBS-subsided treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025. ANDPatient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was newly diagnosed, (b) the condition was confirmed by a histological diagnosis, (c) the patient was/is ineligible for a stem cell transplant, (d) the treatment is being given as triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, (iii) dexamethasone, (e) patient is not receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.	Compliance with Authority Required procedures
C17663	P17663	CN17663	Adalimumab	Moderate to severe hidradenitis suppurativaSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction. ANDPatient must have demonstrated a response to treatment with this drug for this condition.Must be treated by a dermatologist.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17666	P17666	CN17666	Iptacopan	Paroxysmal nocturnal haemoglobinuria (PNH)Return from PBS-subsidised eculizumab post pregnancy or from PBS-subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancyPatient must have received prior PBS-subsidised treatment with this drug for this condition. ANDPatient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)' criteria. orPatient must have received prior PBS-subsidised treatment with at least one C5 inhibitor and must be returning to iptacopan treatment for reasons other than post pregnancy. ANDPatient must have experienced clinical improvement as a result of treatment with this drug. orPatient must have experienced a stabilisation of the condition as a result of treatment with this drug. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist. orMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x109/L)(iii) White Cell Count (x109/L)(iv) Reticulocytes (x109/L)(v) Neutrophils (x109/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH: ULN ratio (in figures, rounded to one decimal place)Patients may qualify under this treatment phase more than once.	Compliance with Written Authority Required procedures
C17670	P17670	CN17670	Secukinumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 1 (new patient)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition. orPatient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. orPatient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 16 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count; and(iii) the name of the antibiotic/s received for two separate courses each of three months; or(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The details of two proposed prescriptions should be submitted with every initial application for this drug.Prescribing the 150 mg presentation:One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.Prescribing the 300 mg presentation:One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C17671	P17671	CN17671	Secukinumab	Moderate to severe hidradenitis suppurativaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated a response to treatment with this drug for this condition.Must be treated by a dermatologist.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hidradenitis Suppurativa Clinical Response (HiSCR) result.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17676	P17676	CN17676	Iptacopan	Paroxysmal nocturnal haemoglobinuria (PNH)Continuing treatmentPatient must have received PBS-subsidised treatment with this drug for this condition. ANDPatient must have experienced clinical improvement as a result of treatment with this drug. orPatient must have experienced a stabilisation of the condition as a result of treatment with this drug. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist. orMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided on the first continuing authority application:(i) Haemoglobin (g/L)(ii) Platelets (x109/L)(iii) White Cell Count (x109/L)(iv) Reticulocytes (x109/L)(v) Neutrophils (x109/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH: ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
C17677	P17677	CN17677	Everolimus	Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)Initial treatmentPatient must be symptomatic (despite somatostatin analogues). orPatient must have disease progression. ANDThe treatment must be as monotherapy.Disease progression must be documented in the patient's medical records.Patients who have developed progressive disease with any of: (i) sunitinib; (ii) cabozantinib are not eligible to receive PBS-subsidised everolimus for this condition.Patients who have developed intolerance with any of: (i) sunitinib; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus.	Compliance with Authority Required procedures
C17678	P17678	CN17678	Cannabidiol	Seizures of the Lennox-Gastaut syndromePatient must have a diagnosis of Lennox-Gastaut syndrome; the diagnosis should be confirmed by an electroencephalogram (EEG) where possible. ANDPatient must have (as an initiating patient)/have had (as a continuing patient) more than one type of seizure that is not adequately controlled with at least two other antiseizure medications prior to initiating treatment with this medicine. ANDThe treatment must be as adjunctive therapy to other antiseizure medication.Must be treated by a prescriber who is either: (i) a neurologist, (ii) a paediatrician if treatment is being initiated. orMust be treated by a prescriber who is either: (i) a neurologist, (ii) a paediatrician if treatment is being continued or re-initiated. orMust be treated by a general practitioner in consultation with either: (i) a neurologist, (ii) a paediatrician if treatment is being continued.Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17678
C17679	P17679	CN17679	Adalimumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 1 (new patient)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition. orPatient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. orPatient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial 1 (new patient) or Initial 2 (recommencement of treatment) - balance of supplyThe authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count; and(iii) the name of the antibiotic/s received for two separate courses each of three months; or(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics.The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C17680	P17680	CN17680	Secukinumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3. ANDPatient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The details of two proposed prescriptions should be submitted with every initial application for this drug.Prescribing the 150 mg presentation:One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.Prescribing the 300 mg presentation:One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.This restriction is intended for induction dosing only.	Compliance with Written Authority Required procedures
C17681	P17681	CN17681	Secukinumab	Moderate to severe hidradenitis suppurativaInitial treatment - Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have had 3 treatment failures within this treatment cycle to PBS-subsidised biological medicines for this condition. ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a dermatologist.Assessment of disease severity must be no more than 4 weeks old at the time of application.A response to treatment is defined as:Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.An application for a patient who has received PBS-subsidised treatment with this drug, has not experienced treatment failure, and wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(i) the Hurley stage grading; and(ii) the AN count.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription(s); and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The details of two proposed prescriptions should be submitted with every initial application for this drug.Prescribing the 150 mg presentation:One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.Prescribing the 300 mg presentation:One prescription should be for the induction doses, containing a quantity of 4 doses of 300 mg and no repeats and the second prescription should be for 1 dose of 300 mg and 3 repeats.This restriction is intended for induction dosing only.	Compliance with Written Authority Required procedures
C17695	P17695	CN17695	Iptacopan	Paroxysmal nocturnal haemoglobinuria (PNH)Initial treatment (new patient)Patient must not have received prior treatment with this drug for this condition. ANDPatient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months. ANDPatient must have experienced an inadequate response/intolerance to either: (i) Complement 5 (C5) inhibitor, (ii) pegcetacoplan. ANDPatient must have received treatment with at least one complement inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred. ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a haematologist. orMust be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:(i) Haemoglobin (g/L)(ii) Platelets (x109/L)(iii) White Cell Count (x109/L)(iv) Reticulocytes (x109/L)(v) Neutrophils (x109/L)(vi) Granulocyte clone size (%)(vii) Lactate Dehydrogenase (LDH)(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory(ix) the LDH: ULN ratio (in figures, rounded to one decimal place)	Compliance with Written Authority Required procedures
C17696	P17696	CN17696	Lanreotide	Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe condition must be unresectable locally advanced disease or metastatic disease. ANDThe condition must be World Health Organisation (WHO) grade 1 or 2. ANDThe treatment must be either: (i) as monotherapy; (ii) in combination with cabozantinib.Patient must be at least 18 years of age.WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.	Compliance with Authority Required procedures - Streamlined Authority Code 17696
C17701	P17701	CN17701	Odevixibat	Progressive familial intrahepatic cholestasis (PFIC)Initial treatment (PFIC diagnosed prior to turning 18 years of age)Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication. ANDPatient must have a clinical diagnosis of progressive familial intrahepatic cholestasis (PFIC). ANDPatient must have elevated serum bile acids at treatment initiation with this drug. ANDPatient must be experiencing itch at treatment initiation with this drug, with other factors causing pruritus excluded through both: (i) physical examination, (ii) patient history. ANDPatient must have had an average pruritus score of at least 2 on the PrucisionTM ObsRO Pruritus Scale assessed on three occasions over a one-week period prior to treatment initiation with this drug.Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist.Patient must be aged between 6 months and 17 years inclusive. orPatient must be/have been diagnosed prior to turning 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the pruritus score using the PrucisionTM ObsRO Pruritus scale;(2) details of serum bile acids (date and micromol/L).If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescriber must exclude any other causes of pruritus which include any of the following:(i) drug related (e.g., opioid-related pruritus);(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; chronic kidney disease; polycythaemia vera/leukaemia/lymphoma; hypothyroidism; uncontrolled diabetes, eczema, scabies).At the time of the authority application, the prescriber should request the appropriate strength(s) and quantity based on the patient's weight, according to the dosing schedule in the TGA-approved Product Information to provide sufficient drug for one month's supply with 2 repeats. A separate authority approval is required for each strength requested.An application for continuing treatment must occur following an assessment of response conducted up to 3 months of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.An application for dose modification treatment must occur following an assessment of response conducted from 1 month of therapy up to 3 months of therapy. This will enable ongoing treatment for those who meet the dose modification restriction criteria for PBS-subsidised treatment.If a patient fails to demonstrate a response to treatment with this drug after 1 month, they will be eligible to receive PBS-subsidised treatment at a higher dose with this drug for this condition under the dose modification treatment phase for a maximum of 5 months; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs within this treatment phase.All diagnostic reports/tools must be documented in the patient's medical records.An adequate clinical response to initial treatment is defined as an average of at least 1 grade improvement in pruritus score on the PrucisionTM ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.Eligible patients must not be recommencing treatment directly through this treatment phase.	Compliance with Written Authority Required procedures
C17703	P17703	CN17703	Odevixibat	Progressive familial intrahepatic cholestasis (PFIC)Initial treatment (PFIC diagnosed after turning 18 years of age)Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication. ANDPatient must have a clinical diagnosis of progressive familial intrahepatic cholestasis (PFIC). ANDPatient must have elevated serum bile acids at treatment initiation with this drug. ANDPatient must be experiencing itch at treatment initiation with this drug, with other factors causing pruritus excluded through both: (i) physical examination, (ii) patient history. ANDPatient must have had an average pruritus score of at least 2 on the PrucisionTM ObsRO Pruritus Scale assessed on three occasions over a one-week period prior to treatment initiation with this drug.Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).Patient must be/have been diagnosed after turning 18 years of age.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the pruritus score using the PrucisionTM ObsRO Pruritus scale;(2) details of serum bile acids (date and micromol/L).If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescriber must exclude any other causes of pruritus which include any of the following:(i) drug related (e.g., opioid-related pruritus);(ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy;(iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; chronic kidney disease; polycythaemia vera/leukaemia/lymphoma; hypothyroidism; uncontrolled diabetes, eczema, scabies).At the time of the authority application, the prescriber should request the appropriate strength(s) and quantity based on the patient's weight, according to the dosing schedule in the TGA-approved Product Information to provide sufficient drug for one month's supply with 2 repeats. A separate authority approval is required for each strength requested.An application for continuing treatment must occur following an assessment of response conducted up to 3 months of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.An application for dose modification treatment must occur following an assessment of response conducted from 1 month of therapy up to 3 months of therapy. This will enable ongoing treatment for those who meet the dose modification restriction criteria for PBS-subsidised treatment.If a patient fails to demonstrate a response to treatment with this drug after 1 month, they will be eligible to receive PBS-subsidised treatment at a higher dose with this drug for this condition under the dose modification treatment phase for a maximum of 5 months; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs within this treatment phase.All diagnostic reports/tools must be documented in the patient's medical records.An adequate clinical response to initial treatment is defined as an average of at least 1 grade improvement in pruritus score on the PrucisionTM ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.Eligible patients must not be recommencing treatment directly through this treatment phase.	Compliance with Written Authority Required procedures
C17705	P17705	CN17705	Odevixibat	Progressive familial intrahepatic cholestasis (PFIC)Continuing treatment (PFIC diagnosed prior to turning 18 years of age)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated an adequate clinical response to the most recent course of treatment. orPatient must be undergoing dose escalation to 120 micrograms/kg/day if they were unable to maintain a previously demonstrated adequate clinical response at 40 micrograms/kg/day in continuing treatment. ANDPatient must not be undergoing treatment with this drug for this condition, where an adequate clinical response was unable to be maintained at 120 micrograms/kg/day.Must be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist. orMust be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the PrucisionTM ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.Confirmation of eligibility for continuing treatment must be provided with the authority application and documented in the patient's medical records (include assessment of adequate clinical response to preceding supply).A patient may be eligible for treatment at the higher dose (120 micrograms/kg/day), if a loss of response occurred, or if an adequate response was unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment. To be eligible for continuing treatment at the higher dose (120 micrograms/kg/day), the patient must demonstrate and maintain an adequate clinical response at the higher dose.	Compliance with Authority Required procedures
C17706	P17706	CN17706	Etanercept	Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDThe condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) the date of the last continuing prescription.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17707	P17707	CN17707	AdalimumabEtanerceptTofacitinib	Severe active juvenile idiopathic arthritisContinuing treatmentMust be treated by a rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 17707
C17709	P17709	CN17709	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDThe condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis.Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) the date of the last continuing prescription.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17710	P17710	CN17710	Tocilizumab	Severe active juvenile idiopathic arthritisContinuing treatmentMust be treated by a rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must be under 30kg. ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 17710
C17713	P17713	CN17713	AdalimumabEtanercept	Severe active juvenile idiopathic arthritisContinuing treatmentMust be treated by a rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 17713
C17715	P17715	CN17715	Adalimumab	Enthesitis/spondylitis related juvenile idiopathic arthritisInitial treatmentPatient must have a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. orPatient must have had a break in treatment of at least 2 years from the most recently prescribed PBS-subsidised biological medicine for this condition. ANDPatient must have failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months. orPatient must have failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age.If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.The following must be provided at the time of application and documented in the patient's medical records:(1) details of prior treatment including dose and duration of treatment; and(i) if applicable, the baseline Juvenile Spondyloarthritis Disease Activity Index score; or(ii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17717	P17717	CN17717	Adalimumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDThe condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) the date of the last continuing prescription.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17719	P17719	CN17719	Adalimumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate. orPatient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:(a) an active joint count of at least 10 active (swollen and tender) joints; or(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or(c) active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or(e) development/worsening of erosive disease due to active arthritis.The assessment of response to prior treatment must be documented in the patient's medical records.The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) details of prior treatment including dose and duration of treatment.At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17721	P17721	CN17721	Odevixibat	Progressive familial intrahepatic cholestasis (PFIC)Continuing treatment (PFIC diagnosed after turning 18 years of age)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated an adequate clinical response to the most recent course of treatment. orPatient must be undergoing dose escalation to 120 micrograms/kg/day if they were unable to maintain a previously demonstrated adequate clinical response at 40 micrograms/kg/day in continuing treatment. ANDPatient must not be undergoing treatment with this drug for this condition, where an adequate clinical response was unable to be maintained at 120 micrograms/kg/day.Must be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC). orMust be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the PrucisionTM ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.Confirmation of eligibility for continuing treatment must be provided with the authority application and documented in the patient's medical records (include assessment of adequate clinical response to preceding supply).A patient may be eligible for treatment at the higher dose (120 micrograms/kg/day), if a loss of response occurred, or if an adequate response was unable to be maintained at the lower dose (40 micrograms/kg/day) during continuing treatment. To be eligible for continuing treatment at the higher dose (120 micrograms/kg/day), the patient must demonstrate and maintain an adequate clinical response at the higher dose.	Compliance with Authority Required procedures
C17722	P17722	CN17722	Odevixibat	Progressive familial intrahepatic cholestasis (PFIC)Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed after turning 18 years of age)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have demonstrated an adequate clinical response after at least 1 month and up to 3 months following commencement of treatment at 40 micrograms/kg/day.Patient must be undergoing treatment with this drug for this condition at 120 micrograms/kg/day. ANDMust be treated by a specialist hepatologist experienced in the management of progressive familial intrahepatic cholestasis (PFIC). orMust be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).At the time of the authority application, the prescriber should request sufficient quantity and repeats to provide for the balance to complete up to 6 months of treatment (inclusive of initial and dose modification treatment), if dose modification is being accessed following initial treatment.An application for continuing treatment must occur following an assessment of response conducted up to a maximum of 6 months from initiation of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.If a patient fails to demonstrate a response to treatment 6 months after initiating treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the PrucisionTM ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.Confirmation of eligibility for dose modification treatment must be documented in the patient's medical records (include assessment of response score after at least 1 month and up to 3 months after commencing initial treatment).Any further authority applications occurring immediately after access through this dose modification listing are not to occur through the initial treatment listing.Dose modificationWhere the drug's Product Information indicates variable dosing regimens based on the individual's response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word 'cancelled'. This treatment phase listing recognises that a patient's optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.Eligible patients must not be recommencing treatment directly through this treatment phase.	Compliance with Authority Required procedures
C17724	P17724	CN17724	Etanercept	Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate. orPatient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:(a) an active joint count of at least 10 active (swollen and tender) joints; or(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or(c) active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or(e) development/worsening of erosive disease due to active arthritis.The assessment of response to prior treatment must be documented in the patient's medical records.The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) details of prior treatment including dose and duration of treatment.At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17725	P17725	CN17725	Etanercept	Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. ANDPatient must not receive more than 16 weeks of treatment under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
C17730	P17730	CN17730	Adalimumab	Enthesitis/spondylitis related juvenile idiopathic arthritisTransitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026. ANDPatient must have, prior to initiating treatment with this drug for this condition, a diagnosis of enthesitis/spondylitis related juvenile idiopathic arthritis defined by at least one of the following: (i) peripheral arthritis and enthesitis, (ii) inflammatory sacroiliitis on Magnetic Resonance Imaging (MRI) plus at least 3 months of inflammatory back pain, (iii) arthritis or enthesitis plus at least 2 of: (a) sacroiliac joint tenderness, (b) inflammatory back pain, (c) presence of HLA-B27 antigen, (d) acute (symptomatic) anterior uveitis, (e) history of spondyloarthritis in a first-degree relative. ANDPatient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for axial disease (sacroiliitis and/or spondylitis), following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) whilst completing an appropriate exercise program, for a total period of 3 months. orPatient must have, prior to initiating treatment with this drug for this condition, failed to achieve an adequate response for peripheral disease (arthritis and/or enthesitis) following treatment with at least 2 NSAIDs, and either: (i) methotrexate at a dose of 15 mg per square metre (maximum 20 mg) weekly, (ii) sulfasalazine at a dose of 20 mg/kg (maximum 1 g) twice daily, whilst completing an appropriate exercise program, for a total period of 3 months. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a paediatric rheumatologist. orMust be treated by a rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age, prior to commencement of this drug for this condition.If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If treatment with methotrexate, sulfasalazine or NSAIDs is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to methotrexate, sulfasalazine or NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, details of the toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:(a) a Juvenile Spondyloarthritis Disease Activity Index score greater than 2; or(b) persistent symptoms of axial spondylitis or sacroiliitis with prior confirmatory Magnetic Resonance Imaging (MRI) assessed by a clinician experienced with juvenile spondyloarthropathy.The following must be provided at the time of application and documented in the patient's medical records:(1) details of prior treatment including dose and duration of treatment; and(i) if applicable, a baseline Juvenile Spondyloarthritis Disease Activity Index score; or(ii) if applicable, the current Juvenile Spondyloarthritis Disease Activity Index score; or(iii) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) of the MRI demonstrating inflammatory spondylitis or sacroiliitis; or(iv) if applicable, details (name of the report provider, date of the report and unique identifying number/code that links report to the individual patient) demonstrating the presence of HLA-B27.The Juvenile Spondyloarthritis Disease Activity Index score must be assessed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17731	P17731	CN17731	Adalimumab	Enthesitis/spondylitis related juvenile idiopathic arthritisInitial treatment - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction to complete 16 weeks of treatment. ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.	Compliance with Authority Required procedures
C17733	P17733	CN17733	Adalimumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. ANDPatient must not receive more than 16 weeks of treatment under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient. Up to a maximum of 3 repeats will be authorised.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
C17734	P17734	CN17734	Adalimumab	Severe active juvenile idiopathic arthritisTransitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 January 2026. ANDPatient must have, prior to initiating treatment with this drug for this condition, demonstrated severe intolerance of, or toxicity due to, methotrexate. orPatient must have, prior to initiating treatment with this drug for this condition, demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age, prior to commencement of this drug for this condition.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:(a) an active joint count of at least 10 active (swollen and tender) joints; or(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or(c) active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or(e) development/worsening of erosive disease due to active arthritis.The assessment of response to prior treatment must be documented in the patient's medical records.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) details of prior treatment including dose and duration of treatment.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17736	P17736	CN17736	Adalimumab	Enthesitis/spondylitis related juvenile idiopathic arthritisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a paediatric rheumatologist. orMust be treated by a rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.An adequate response is defined as an improvement from baseline in the Juvenile Spondyloarthritis Disease Activity Index score by at least 30% or an improvement in the persistent symptoms of axial spondylitis or sacroiliitis.If a patient fails to demonstrate a response to treatment with this drug, they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition until 2 years have elapsed. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 2 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed, and the date of the first application submitted for approval.Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 17736
C17737	P17737	CN17737	Tofacitinib	Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. ANDPatient must not receive more than 16 weeks of treatment under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
C17738	P17738	CN17738	Odevixibat	Progressive familial intrahepatic cholestasis (PFIC)Dose modification (Dose escalation from initial treatment phase; for PFIC diagnosed prior to turning 18 years of age)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have demonstrated an adequate clinical response after at least 1 month and up to 3 months following commencement of treatment at 40 micrograms/kg/day.Patient must be undergoing treatment with this drug for this condition at 120 micrograms/kg/day. ANDMust be treated by a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC), who is either a: (i) gastroenterologist, (ii) hepatologist. orMust be treated by a medical practitioner under the supervision of a specialist experienced in the management of progressive familial intrahepatic cholestasis (PFIC).At the time of the authority application, the prescriber should request sufficient quantity and repeats to provide for the balance to complete up to 6 months of treatment (inclusive of initial and dose modification treatment), if dose modification is being accessed following initial treatment.An application for continuing treatment must occur following an assessment of response conducted up to a maximum of 6 months from initiation of therapy. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.If a patient fails to demonstrate a response to treatment 6 months after initiating treatment with this drug for this condition (inclusive of initial and dose modification treatment), they will no longer be eligible to receive PBS-subsidised treatment with this drug for this condition.An adequate clinical response under this treatment phase is defined as an average of at least 1 grade improvement in pruritus score on the PrucisionTM ObsRO Pruritus Scale, assessed on 3 occasions over a one-week period prior to assessment of response.Confirmation of eligibility for dose modification treatment must be documented in the patient's medical records (include assessment of response score after at least 1 month and up to 3 months after commencing initial treatment).Any further authority applications occurring immediately after access through this dose modification listing are not to occur through the initial treatment listing.Dose modificationWhere the drug's Product Information indicates variable dosing regimens based on the individual's response/tolerance, apply under this listing to continue treatment with the new strength. Mark any remaining repeat prescriptions for the discontinued strength with the word 'cancelled'. This treatment phase listing recognises that a patient's optimal dose may not always be immediately apparent at the time of treatment initiation and therefore does not require confirmation of an objective, adequate response to the preceding supply of drug.Eligible patients must not be recommencing treatment directly through this treatment phase.	Compliance with Authority Required procedures
C17742	P17742	CN17742	Tocilizumab	Severe active juvenile idiopathic arthritisContinuing treatmentMust be treated by a rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDPatient must be 30kg or over. ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures - Streamlined Authority Code 17742
C17745	P17745	CN17745	Tofacitinib	Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate. orPatient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be under 18 years of age.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:(a) an active joint count of at least 10 active (swollen and tender) joints; or(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or(c) active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or(e) development/worsening of erosive disease due to active arthritis.The assessment of response to prior treatment must be documented in the patient's medical records.The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) details of prior treatment including dose and duration of treatment.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17746	P17746	CN17746	Tofacitinib	Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDThe condition must have either: (a) a total active joint count of at least 10 active (swollen and tender) joints; (b) at least 2 active major joints; (c) active arthritis affecting the cervical spine or temporomandibular joint; (d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; (e) development/worsening of erosive disease due to active arthritis. ANDPatient must not receive more than 16 weeks of treatment under this restriction.Active major joints are defined as: elbow, wrist, knee, ankle, shoulder, and hip.All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.Where the baseline active joint count is based on total active joints (i.e. more than 10 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active major joints, the response must be demonstrated on the total number of active major joints.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) the date of the last continuing prescription.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17748	P17748	CN17748	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 10 active joints; or(b) a reduction in the number of the following active joints, from at least 2, by at least 50%: elbow, wrist, knee, ankle, shoulder, and hip; or(c) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least a 50% reduction from baseline on the frequency of oral or intra-articular corticosteroids use to control flares of disease associated with active arthritis; or(e) an improvement from baseline by at least 50% in the signs and symptoms attributable to active arthritis affecting joint(s) with erosive disease.The assessment of response to treatment must be documented in the patient's medical records.Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
C17757	P17757	CN17757	Brentuximab vedotin	Stage III or IV CD30 positive Hodgkin lymphomaThe treatment must be for first line therapy for this condition. ANDThe treatment must be for curative intent. ANDThe treatment must be in combination with at least the following: (i) doxorubicin, (ii) vinblastine. ANDThe treatment must not be in combination with (i) etoposide, (ii) cyclophosphamide. ANDThe treatment must not be more than 6 treatment cycles under this restriction in a lifetime.	Compliance with Authority Required procedures
C17760	P17760	CN17760	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a paediatric rheumatologist. orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have demonstrated severe intolerance of, or toxicity due to, methotrexate. orPatient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months.Patient must be under 18 years of age.Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:(a) an active joint count of at least 10 active (swollen and tender) joints; or(b) an active joint count of at least 2, affecting the following joints: elbow, wrist, knee, ankle, shoulder, and hip; or(c) active arthritis affecting the cervical spine or temporomandibular joint; or(d) at least 2 separate episodes of oral or intra-articular corticosteroids use within 12 months to control flares of disease; or(e) development/worsening of erosive disease due to active arthritis.The assessment of response to prior treatment must be documented in the patient's medical records.The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the date of assessment of severe active juvenile idiopathic arthritis; and(b) details of prior treatment including dose and duration of treatment.Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures
C17774	P17774	CN17774	AbemaciclibRibociclib	Locally advanced or metastatic breast cancerInitial treatmentPatient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. orPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal. ANDThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be inoperable. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. ANDThe treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant. orThe treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17786	P17786	CN17786	Lenvatinib	Stage IV clear cell variant renal cell carcinoma (RCC)Initial treatmentPatient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug and pembrolizumab of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records. ANDThe condition must be untreated. ANDPatient must have a WHO performance status of 2 or less.Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib. orPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. ANDMust be treated by a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17786
C17789	P17789	CN17789	Sunitinib	Metastatic or unresectable malignant gastrointestinal stromal tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe condition must not be resectable. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17789
C17791	P17791	CN17791	Cabozantinib	Locally advanced or metastatic differentiated thyroid cancerContinuing treatmentThe condition must be refractory to radioactive iodine. orPatient must be deemed ineligible for treatment with radioactive iodine. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17791
C17793	P17793	CN17793	Lenvatinib	Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaInitial treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must not be suitable for transarterial chemoembolisation. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have Child Pugh class A. ANDThe condition must be untreated with systemic therapy. orPatient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy, (iii) durvalumab/tremelimumab combination therapy.Must be treated by a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17793
C17794	P17794	CN17794	Cabozantinib	Stage IV renal cell carcinoma (RCC)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST). ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17794
C17796	P17796	CN17796	Olaparib	Castration resistant metastatic carcinoma of the prostateContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not be subsidised in combination with: (i) chemotherapy, (ii) a novel hormonal drug.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17800	P17800	CN17800	Niraparib	High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tabletsThe treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation). ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17802	P17802	CN17802	Crizotinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. ANDThe condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.Must be treated by a medical practitioner.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be documented in the patient's medical records:(a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.	Compliance with Written Authority Required procedures
C17805	P17805	CN17805	Crizotinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17807	P17807	CN17807	Cobimetinib	Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug. ANDPatient must be receiving PBS-subsidised vemurafenib concomitantly for this condition. ANDPatient must have stable or responding disease.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17807
C17809	P17809	CN17809	Degarelix	Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) carcinoma of the prostateMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17811	P17811	CN17811	Goserelin	Carcinoma of the prostateThe condition must be locally advanced (stage C). orThe condition must be metastatic (stage D).Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17812	P17812	CN17812	LeuprorelinTriptorelin	Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostateMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17814	P17814	CN17814	Goserelin and bicalutamideLeuprorelin and bicalutamide	Carcinoma of the prostateThe condition must be metastatic (stage D). ANDPatient must require a combination of an antiandrogen and a GnRH (LH-RH) agonist.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17817	P17817	CN17817	Dasatinib	Acute lymphoblastic leukaemiaMaintenance of first complete remissionPatient must have previously received PBS-subsidised treatment with this drug for this condition. orPatient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition. ANDThe condition must be expressing the Philadelphia chromosome. orThe condition must have the transcript BCR-ABL. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose. orPatient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Conditions for PBS-subsidy beyond 24 months of treatment:On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm that:1) The condition is expressing the Philadelphia chromosome,2) Measurable residual disease (MRD) is present,3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,4) MRD has been confirmed within the preceding 6 months of this authority application,5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.	Compliance with Authority Required procedures
C17821	P17821	CN17821	Dasatinib	Acute lymphoblastic leukaemiaInduction and Consolidation therapyPatient must be newly diagnosed. ANDThe condition must be expressing the Philadelphia chromosome. orThe condition must have the transcript BCR-ABL. ANDThe treatment must be in combination with chemotherapy or corticosteroids. ANDPatient must not have previously experienced a failure to respond to the PBS-subsidised first line treatment with this drug for this condition. orPatient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with imatinib as a first-line therapy for this condition.Must be treated by a medical practitioner.The authority application must be made in writing and must include:(a) details of the proposed prescription; and(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and(c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow. (The date of the relevant pathology report needs to be provided).	Compliance with Written Authority Required procedures
C17826	P17826	CN17826	Imatinib	Acute lymphoblastic leukaemiaMaintenance of first complete remissionPatient must have previously received PBS-subsidised treatment with this drug for this condition. orPatient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition. ANDThe condition must be expressing the Philadelphia chromosome. orThe condition must have the transcript BCR-ABL. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. ANDPatient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose. orPatient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.Conditions for PBS-subsidy beyond 24 months of treatment:On the first occasion an authority application extends PBS-subsidy beyond 24 months, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring that:1) The condition is expressing the Philadelphia chromosome,2) Measurable residual disease (MRD) is present,3) MRD has been confirmed in at least one of: (i) marrow, (ii) peripheral blood,4) MRD has been confirmed within the preceding months of this authority application,5) MRD has been ascertained by at least one of: (i) a molecular method, (ii) flow cytometry,6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.	Compliance with Authority Required procedures - Streamlined Authority Code 17826
C17834	P17834	CN17834	Ponatinib	Acute lymphoblastic leukaemiaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must not have progressive disease.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17835	P17835	CN17835	Ponatinib	Acute lymphoblastic leukaemiaInitial treatmentThe condition must be expressing the Philadelphia chromosome. orThe condition must have the transcript BCR-ABL. ANDPatient must have failed prior treatment with PBS-subsidised dasatinib for this condition. orPatient must have developed intolerance to PBS-subsidised dasatinib of a severity requiring treatment withdrawal.Must be treated by a medical practitioner.Failure of treatment with dasatinib is defined as either:1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with PBS-subsidised dasatinib for this condition; or2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by PBS-subsidised dasatinib for this condition; or3. Rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission; OR rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition.The authority application must be made in writing and must include:1. details of the proposed prescription; and2. a completed Acute Lymphoblastic Leukaemia ponatinib PBS Authority Application - Supporting Information Form; and3. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided; or4. pathology reports documenting rising levels of BCR-ABL1 transcript on two consecutive occasions in a patient in complete remission while being treated with PBS-subsidised dasatinib for this condition. The date of the relevant pathology report(s) need(s) to be provided.	Compliance with Written Authority Required procedures
C17838	P17838	CN17838	Ibrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First continuing treatment (treatment cycles 4 to 9 inclusive) of first-line therapyPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses). ANDThe treatment must cease upon disease progression.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).	Compliance with Authority Required procedures
C17847	P17847	CN17847	AbemaciclibRibociclib	Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17848	P17848	CN17848	CapecitabineCyclophosphamideHydroxycarbamideMercaptopurineTemozolomide	For prescribing by certain health practitionersMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17851	P17851	CN17851	Palbociclib	Locally advanced or metastatic breast cancerInitial treatmentPatient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. orPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal. ANDThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be inoperable. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. ANDThe treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor. orThe treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17853	P17853	CN17853	Ribociclib	Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant. ANDPatient must require dosage reduction requiring a pack of 21 tablets. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17854	P17854	CN17854	Temozolomide	Glioblastoma multiformePatient must be undergoing concomitant radiotherapy. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17855	P17855	CN17855	Vinorelbine	Locally advanced or metastatic non-small cell lung cancerMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17856	P17856	CN17856	Sunitinib	Stage IV clear cell variant renal cell carcinoma (RCC)Continuing treatment beyond 3 monthsPatient must have received an initial authority prescription for this drug for this condition. ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST). ANDThe treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.	Compliance with Authority Required procedures - Streamlined Authority Code 17856
C17860	P17860	CN17860	Lenvatinib	Stage IV clear cell variant renal cell carcinoma (RCC)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib. orPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. orPatient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.In a patient who has experienced an intolerance to pembrolizumab, details of intolerance must be documented in the patient's medical record.	Compliance with Authority Required procedures - Streamlined Authority Code 17860
C17862	P17862	CN17862	Sunitinib	Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)Continuing treatmentPatient must have received an initial authority prescription for this drug for this condition. ANDPatient must not have disease progression. ANDThe treatment must be as monotherapy.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 17862
C17864	P17864	CN17864	Lenvatinib	Locally advanced or metastatic differentiated thyroid cancerInitial treatmentThe condition must be refractory to radioactive iodine. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have symptomatic progressive disease prior to treatment. orPatient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures. ANDPatient must have thyroid stimulating hormone adequately suppressed. ANDPatient must be one in whom surgery is inappropriate. ANDPatient must not be a candidate for radiotherapy with curative intent. ANDPatient must have a WHO performance status of 2 or less.Must be treated by a medical practitioner.Radioactive iodine refractory is defined as:(i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or(ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or(iii) progression within 12 months of a single RAI treatment; or(iv) progression after two RAI treatments administered within 12 months of each other.	Compliance with Authority Required procedures - Streamlined Authority Code 17864
C17865	P17865	CN17865	Lenvatinib	Locally advanced or metastatic differentiated thyroid cancerContinuing treatmentThe condition must be refractory to radioactive iodine. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17865
C17867	P17867	CN17867	Talazoparib	Castration resistant metastatic carcinoma of the prostateThe condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation. ANDPatient must not have received prior PBS-subsidised novel hormonal drug in any non-metastatic setting of prostate cancer prior to commencing treatment with this drug for this condition. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance score no higher than 1 prior to treatment initiation. ANDPatient must be undergoing concurrent treatment with enzalutamide, unless an intolerance to enzalutamide requires either a: (i) temporary cessation, (ii) permanent discontinuation. ANDThe treatment must not be a PBS-subsidised benefit beyond disease progression.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17870	P17870	CN17870	BrigatinibCeritinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be as monotherapy. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17873	P17873	CN17873	Abiraterone	Castration resistant metastatic carcinoma of the prostateThe treatment must be used in combination with a corticosteroid. ANDThe treatment must not be used in combination with chemotherapy. ANDPatient must have a WHO performance status of 2 or less. ANDThe treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits. ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). orPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17875	P17875	CN17875	ApalutamideDarolutamideEnzalutamide	Castration resistant non-metastatic carcinoma of the prostateThe condition must have evidence of an absence of distant metastases on the most recently performed conventional medical imaging used to evaluate the condition. ANDThe condition must be associated with a prostate-specific antigen level that was observed to have at least doubled in value in a time period of within 10 months anytime prior to first commencing treatment with this drug. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation. ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug. ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). orPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.Patient must be undergoing concurrent treatment with androgen deprivation therapy. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Prescribing instructions:Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.	Compliance with Authority Required procedures
C17877	P17877	CN17877	Abiraterone and methylprednisoloneApalutamideDarolutamide	Metastatic castration sensitive carcinoma of the prostateThe treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy. ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). orPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.Patient must be undergoing concurrent androgen deprivation therapy. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17879	P17879	CN17879	Dasatinib	Acute lymphoblastic leukaemiaInitial treatmentThe condition must be expressing the Philadelphia chromosome, orThe condition must have the transcript BCR-ABL; ANDPatient must have failed treatment with chemotherapy; ANDPatient must have failed treatment with imatinib; ANDPatient must have failed an allogeneic haemopoietic stem cell transplantation if applicable.Must be treated by a medical practitioner.Failure of treatment is defined as either:(i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;(ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;(iii) Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites, or the presence of cells expressing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.The authority application must be made in writing and must include:(a) details of the proposed prescription; AND(b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; AND(c) a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.	Compliance with Written Authority Required procedures
C17880	P17880	CN17880	GoserelinMedroxyprogesterone	Breast cancerThe condition must be hormone receptor positive.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17881	P17881	CN17881	Medroxyprogesterone	Endometrial cancerMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17884	P17884	CN17884	Imatinib	Dermatofibrosarcoma protuberansContinuing treatmentThe condition must be unresectable. orThe condition must be locally recurrent. orThe condition must be metastatic. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have demonstrated a response to the PBS-subsidised treatment. ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition. ANDThe treatment must not exceed a maximum dose of 800 mg per day.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17884
C17885	P17885	CN17885	Imatinib	Chronic eosinophilic leukaemia or Hypereosinophilic syndromeContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have achieved and maintained a complete haematological response. ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition. ANDThe treatment must not exceed a maximum dose of 400 mg per day.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count and a statement that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17885
C17886	P17886	CN17886	Imatinib	Malignant gastrointestinal stromal tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be given at a dose not exceeding 600 mg per day.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinibPatients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347: 472-80.)	Compliance with Authority Required procedures - Streamlined Authority Code 17886
C17887	P17887	CN17887	Imatinib	Aggressive systemic mastocytosis with eosinophiliaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene. ANDPatient must have achieved and maintained a complete haematological response. ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition. ANDThe treatment must not exceed a maximum dose of 400 mg per day.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17887
C17890	P17890	CN17890	Imatinib	Gastrointestinal stromal tumourContinuing treatmentThe treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST). ANDPatient must be at high risk of recurrence following complete surgical resection of primary GIST. ANDThe treatment must not exceed a dose of 400 mg per day for a period of 36 months in total (initial plus continuing therapy). ANDPatient must have previously been issued with an authority prescription for imatinib for adjuvant treatment following complete resection of primary GIST.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17890
C17893	P17893	CN17893	Idelalisib	Refractory follicular B-cell non-Hodgkin's lymphomaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17893
C17898	P17898	CN17898	AcalabrutinibIbrutinibZanubrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Treatment of relapsed/refractory diseaseThe condition must have relapsed or be refractory to at least one prior therapy. ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must not be undergoing retreatment (second/subsequent treatment course) with this drug where prior treatment of CLL/SLL with this same drug was unable to prevent disease progression. ANDPatient must be undergoing treatment through this treatment phase listing for the first time (initial treatment). orPatient must be undergoing continuing treatment through this treatment phase listing, with disease progression being absent. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17900	P17900	CN17900	Ibrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Second and final continuing treatment (treatment cycles 10 to 15 inclusive) of first-line therapyPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses). ANDThe treatment must cease upon disease progression. orThe treatment must cease upon completion of 15 cycles of treatment with this drug for this condition, whichever comes first.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).	Compliance with Authority Required procedures
C17906	P17906	CN17906	Palbociclib	Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17909	P17909	CN17909	Olaparib	Metastatic breast cancerInitial treatmentThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. ANDPatient must have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting. ANDPatient must not have received PBS-subsidised treatment with this drug in any earlier line of treatment for breast cancer. ANDThe condition must be triple negative breast cancer. orThe condition must be hormone-receptor positive breast cancer and the patient has either: (i) progressive disease after receiving endocrine therapy, (ii) been considered inappropriate for endocrine therapy. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Must be treated by a medical practitioner.Retain all pathology imaging and investigative test results in the patient's medical records. Do not submit copies of these as part of the authority application.Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).	Compliance with Authority Required procedures
C17910	P17910	CN17910	Olaparib	High grade epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation)The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation). ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.	Compliance with Authority Required procedures - Streamlined Authority Code 17910
C17911	P17911	CN17911	Olaparib	High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17912	P17912	CN17912	Niraparib	High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tabletsThe treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation). ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17913	P17913	CN17913	Niraparib	High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tabletsPatient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17914	P17914	CN17914	Lorlatinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication. ANDThe condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C17915	P17915	CN17915	DabrafenibTrametinib	Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection. ANDPatient must not have experienced disease recurrence. ANDPatient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17917	P17917	CN17917	Binimetinib	Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug. ANDPatient must be receiving PBS-subsidised encorafenib concomitantly for this condition. ANDPatient must have stable or responding disease.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17917
C17918	P17918	CN17918	Fulvestrant	Locally advanced or metastatic breast cancerThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be inoperable.Patient must not be premenopausal.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 17918
C17919	P17919	CN17919	Exemestane	Metastatic (Stage IV) breast cancerThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDPatient must be receiving PBS-subsidised everolimus concomitantly for this condition.Patient must not be pre-menopausal.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17923	P17923	CN17923	Medroxyprogesterone	Endometrial cancerThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17927	P17927	CN17927	Zanubrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First line drug treatment of this indicationThe condition must be untreated with drug treatment at the time of the first dose of this drug. orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL. ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug. orPatient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17930	P17930	CN17930	AcalabrutinibIbrutinibZanubrutinib	Mantle cell lymphomaInitial treatmentThe condition must have relapsed or be refractory to at least one prior therapy. ANDPatient must have a WHO performance status of 0 or 1. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must be untreated with Bruton's tyrosine kinase inhibitor therapy. orPatient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C17931	P17931	CN17931	AcalabrutinibIbrutinibZanubrutinib	Mantle cell lymphomaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17939	P17939	CN17939	Abiraterone and methylprednisoloneAbiraterone and prednisolone	Castration resistant metastatic carcinoma of the prostateThe treatment must not be used in combination with chemotherapy. ANDPatient must have a WHO performance status of 2 or less. ANDThe treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of: (i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits. ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). orPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17940	P17940	CN17940	Ribociclib	Locally advanced or metastatic breast cancerInitial treatmentPatient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. orPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal. ANDThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be inoperable. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. ANDThe treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant. orThe treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. ANDPatient must require dosage reduction requiring a pack of 42 tablets.Must be treated by a medical practitioner.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17943	P17943	CN17943	Lenvatinib	Advanced, metastatic or recurrent endometrial carcinomaInitial treatmentPatient must have received prior treatment with platinum-based chemotherapy. ANDThe condition must be untreated with each of: (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib. orPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. ANDMust be treated by a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 17943
C17945	P17945	CN17945	Olaparib	High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (BRCA1/2 gene mutation)The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation). ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17946	P17946	CN17946	Niraparib	High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancerContinuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tabletsPatient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition. ANDThe treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17947	P17947	CN17947	Ceritinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatmentThe treatment must be as monotherapy. ANDThe condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C17949	P17949	CN17949	DabrafenibEncorafenibVemurafenib	Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug. ANDPatient must have stable or responding disease.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17949
C17950	P17950	CN17950	DabrafenibTrametinib	Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanomaInitial treatmentThe treatment must be adjuvant to complete surgical resection. ANDThe condition must be positive for a BRAF V600 mutation. ANDPatient must have a WHO performance status of 1 or less. ANDPatient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition. ANDPatient must not have received prior PBS-subsidised treatment for this condition. ANDThe treatment must commence within 12 weeks of complete resection. ANDPatient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C17951	P17951	CN17951	Trametinib	Unresectable Stage III or Stage IV malignant melanomaContinuing treatmentPatient must have previously been issued with an authority prescription for this drug. ANDPatient must be receiving PBS-subsidised dabrafenib concomitantly for this condition. ANDPatient must have stable or responding disease.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 17951
C17953	P17953	CN17953	Enzalutamide	Castration resistant metastatic carcinoma of the prostateThe treatment must not be used in combination with chemotherapy. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug. ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). orPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. orPatient must have been receiving PBS-subsidised treatment with abiraterone or abiraterone plus methylprednisolone for castration resistant metastatic prostate cancer prior to being associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17956	P17956	CN17956	Goserelin	Anticipated premature ovarian failurePatient must be receiving treatment with an alkylating agent for a malignancy or an autoimmune disorder that has a high risk of causing premature ovarian failure. ANDPatient must not receive more than 6 months' of treatment for this condition in a lifetime.Patient must be pre-menopausal.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17958	P17958	CN17958	Medroxyprogesterone	Breast cancerThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDThe condition must be hormone receptor positive.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C17960	P17960	CN17960	Imatinib	Myelodysplastic or myeloproliferative disorderContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe condition must be PDGFRB fusion gene-positive. ANDPatient must have achieved and maintained a complete haematological response. ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition. ANDThe treatment must not exceed a maximum dose of 400 mg per day.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A full blood examination report which demonstrates a complete haematological response and evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 17960
C17961	P17961	CN17961	Zanubrutinib	Waldenstrom macroglobulinaemiaInitial treatmentThe condition must have relapsed or be refractory to at least one prior chemo-immunotherapy. orPatient must be unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. ANDPatient must be untreated with a Bruton's tyrosine kinase inhibitor for this condition. orPatient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C17977	P17977	CN17977	Ribociclib	Locally advanced or metastatic breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. ANDPatient must require dosage reduction requiring a pack of 42 tablets.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C17981	P17981	CN17981	Olaparib	Early breast cancerContinuing treatmentPatient must have received PBS-subsidised treatment with this drug as adjuvant therapy for this condition. ANDPatient must not have developed disease recurrence while receiving treatment with this drug for this condition. ANDThe treatment must not be a PBS-subsidised benefit beyond a total of 52 weeks of treatment (including any non-PBS-subsidised supply). ANDThe treatment must not in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab, (iii) ribociclib.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17984	P17984	CN17984	Dasatinib	Acute lymphoblastic leukaemiaContinuing treatmentThe condition must be expressing the Philadelphia chromosome. orThe condition must have the transcript BCR-ABL. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib. ANDThe condition must not have progressed.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17991	P17991	CN17991	Acalabrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First line drug treatment of this indication - as monotherapyThe condition must be untreated with drug treatment at the time of the first dose of this drug. orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL. ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug. orPatient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C17992	P17992	CN17992	Pembrolizumab	Intermediate or high risk of recurrence clear cell variant renal cell carcinoma (RCC)Patient must have: (i) pT2 with Grade 4 or sarcomatoid features; or (ii) pT3, with any grade without nodal involvement (N0) or distant metastases (M0), or (iii) pT4, any grade N0 and M0, or (iv) any pT, any grade with nodal involvement and M0, or (v) metastatic disease and has undergone complete resection of primary and metastatic lesions; ANDThe treatment must be in addition to complete surgical resection; ANDThe treatment must commence within 12 weeks of complete resection; ANDPatient must have a WHO performance status of 1 or less; ANDPatient must not have previously been treated with systemic therapy for this condition, prior to commencing treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised anti-cancer therapy for this condition; ANDPatient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions, orPatient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 17992
C18002	P18002	CN18002	Olaparib	Metastatic breast cancerContinuing treatmentPatient must have received previous PBS-subsidised treatment with this drug in the metastatic setting. ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication. ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18004	P18004	CN18004	Crizotinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. ANDThe condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing. ANDPatient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition. orPatient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.Must be treated by a medical practitioner.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be documented in the patient's medical records:(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.	Compliance with Written Authority Required procedures
C18007	P18007	CN18007	Zanubrutinib	Waldenstrom macroglobulinaemiaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDThe condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18008	P18008	CN18008	Idelalisib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Initial treatmentThe condition must be confirmed Chronic lymphocytic leukaemia (CLL) prior to initiation of treatment. orThe condition must be confirmed Small lymphocytic lymphoma (SLL) prior to initiation of treatment. ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be in combination with rituximab for up to a maximum of 8 doses under this restriction, followed by monotherapy for this condition. ANDThe condition must have relapsed or be refractory to at least one prior therapy. ANDThe condition must be CD20 positive. ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C18014	P18014	CN18014	Gilteritinib	Relapsed or refractory Acute Myeloid LeukaemiaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must not be for maintenance therapy post-transplant.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.Progressive disease is defined as the presence of any of the following:(a) Leukaemic cells in the CSF; or(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or(d) Extramedullary leukaemia.	Compliance with Authority Required procedures
C18015	P18015	CN18015	Vinorelbine	Advanced breast cancerPatient must have failed standard prior therapy, which includes an anthracycline.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18017	P18017	CN18017	Lenvatinib	Advanced, metastatic or recurrent endometrial carcinomaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib. orPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. orPatient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose. ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 18017
C18018	P18018	CN18018	Lenvatinib	Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinomaContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 18018
C18022	P18022	CN18022	Lorlatinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication. ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18025	P18025	CN18025	Goserelin	EndometriosisThe condition must be visually proven. ANDThe treatment must be for the short-term (up to 6 months).Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C18029	P18029	CN18029	Idelalisib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for Chronic lymphocytic leukaemia. orPatient must have previously received PBS-subsidised treatment with this drug for Small lymphocytic leukaemia. ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18030	P18030	CN18030	Ponatinib	Acute lymphoblastic leukaemiaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition. ANDPatient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18033	P18033	CN18033	Ribociclib	Locally advanced or metastatic breast cancerInitial treatmentPatient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. orPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal. ANDThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDThe condition must be inoperable. ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. ANDThe treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant. orThe treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only. ANDThe treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. ANDPatient must require dosage reduction requiring a pack of 21 tablets.Must be treated by a medical practitioner.Patient must not be premenopausal.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C18037	P18037	CN18037	Exemestane	Metastatic (Stage IV) breast cancerThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDThe condition must be hormone receptor positive. ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative. ANDPatient must be receiving PBS-subsidised everolimus concomitantly for this condition.Patient must not be pre-menopausal.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.
C18039	P18039	CN18039	Ponatinib	Acute lymphoblastic leukaemiaInitial treatmentThe treatment must be the sole PBS-subsidised therapy for this condition. ANDPatient must be expressing the T315I mutation. ANDPatient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor. ANDPatient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate).Must be treated by a medical practitioner.Failure of treatment is defined as either:1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor;2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor;3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.The authority application must be made in writing and must include:1. details of the proposed prescription; and2. a completed Acute Lymphoblastic Leukaemia - ponatinib Initial PBS authority application form; and3. a signed patient acknowledgement; and4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided.	Compliance with Written Authority Required procedures
C18047	P18047	CN18047	IncobotulinumtoxinA	Chronic sialorrheaPatient must be initiating treatment with a Drooling Severity and Frequency Scale (DSFS) score of at least 6. orPatient must be continuing treatment with improvement in the DSFS score of at least 1 point from baseline as assessed by the treating clinician. ANDPatient must have cerebral palsy. orPatient must have traumatic brain injury. orPatient must have developmental disorder.Patient must be aged from 2 to 17 years inclusive.Must be treated by a neurologist. orMust be treated by a rehabilitation specialist. orMust be treated by a paediatrician. orMust be treated by an otolaryngologist surgeon. orMust be treated by a plastic surgeon.	Compliance with Authority Required procedures - Streamlined Authority Code 18047
C18055	P18055	CN18055	Budesonide with formoterol	AsthmaThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids. orPatient must have experienced frequent asthma symptoms while receiving treatment with oral or inhaled corticosteroids and require single maintenance and reliever therapy. orPatient must have experienced frequent asthma symptoms while receiving treatment with a combination of an inhaled corticosteroid and long acting beta-2 agonist and require single maintenance and reliever therapy.	Compliance with Authority Required procedures - Streamlined Authority Code 18055
C18059	P18059	CN18059	IncobotulinumtoxinA	Chronic sialorrheaPatient must be initiating treatment with a Drooling Severity and Frequency Scale (DSFS) score of at least 6. orPatient must be continuing treatment with improvement in the DSFS score of at least 1 point from baseline as assessed by the treating clinician. ANDPatient must have Parkinson's disease. orPatient must have atypical Parkinson's. orPatient must have traumatic brain injury. orPatient must have chronic sialorrhea following an acute event.Patient must be at least 18 years of age.Must be treated by a neurologist. orMust be treated by a rehabilitation specialist. orMust be treated by a geriatrician. orMust be treated by an otolaryngologist surgeon. orMust be treated by a plastic surgeon.	Compliance with Authority Required procedures - Streamlined Authority Code 18059
C18061	P18061	CN18061	Glofitamab	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 March 2026. ANDPatient must have been unable to receive treatment with CAR-T cell therapy prior to commencing treatment with this drug for this condition. ANDPatient must have been unsuitable for stem cell transplant prior to commencing treatment with this drug for this condition. ANDPatient must have had a WHO performance status of 2 or less prior to commencing treatment with this drug for this condition. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components. ANDThe treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.	Compliance with Authority Required procedures
C18064	P18064	CN18064	Bimekizumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDThe condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18065	P18065	CN18065	Bimekizumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18066	P18066	CN18066	Bimekizumab	Severe chronic plaque psoriasisContinuing treatment, Face, hand, footPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18067	P18067	CN18067	Bimekizumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition. ANDThe condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18069	P18069	CN18069	Ipilimumab	Stage III melanomaPatient must not have received prior PBS-subsidised treatment for this condition. ANDThe treatment must be in addition to complete surgical resection. ANDPatient must have a WHO performance status of 1 or less. ANDThe treatment must be in combination with PBS-subsidised treatment with nivolumab.Prescribed amounts must be consistent with the treatment protocol used for an individual patient.When ipilimumab is initially prescribed as a 3-weekly dosing regimen, patients must only receive a maximum of 80 mg every 3 weeks for 2 cycles (i.e., 1 repeat), in combination with nivolumab.	Compliance with Authority Required procedures - Streamlined Authority Code 18069
C18070	P18070	CN18070	Nivolumab	Immunotherapy sensitive advanced or metastatic cancerPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.Patients must only receive a maximum of 240 mg every two weeks, 360 mg every three weeks, or 480 mg every four weeks under a weight based or flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 18070
C18071	P18071	CN18071	Ipilimumab	Immunotherapy sensitive advanced or metastatic cancerPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.The stated maximum amount in this listing is 360 mg however alternative dosing schedules may be prescribed in a quantity up to this amount, but need not be this amount for every cancer type.	Compliance with Authority Required procedures - Streamlined Authority Code 18071
C18079	P18079	CN18079	Ivabradine	Chronic heart failureThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must be symptomatic with NYHA classes II or III. ANDPatient must be in sinus rhythm. ANDPatient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 35%. ANDPatient must have a resting heart rate at or above 77 bpm at the time ivabradine treatment is initiated. ANDPatient must receive concomitant optimal standard chronic heart failure treatment, which must include the maximum tolerated dose of a beta-blocker, unless contraindicated or not tolerated.Resting heart rate should be measured by ECG or echocardiography, after 5 minutes rest.The ECG or echocardiography, result must be documented in the patient's medical records when treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 18079
C18082	P18082	CN18082	Obinutuzumab	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Pre-treatment prior to initiation of glofitamabPatient must be eligible to receive treatment under the PBS listing criteria for glofitamab.Patient is intended to receive a single dose of Obinutuzumab 1000 mg 7 days prior to initiating glofitamab treatment (Cycle 1, Day 1).	Compliance with Authority Required procedures - Streamlined Authority Code 18082
C18083	P18083	CN18083	Bimekizumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Whole body (new patient)Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18084	P18084	CN18084	Bimekizumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle. ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18105	P18105	CN18105	Glofitamab	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Continuing treatment (Cycles 2-12)Patient must have previously received PBS-subsidised treatment with this drug for this condition. ANDThe treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components. ANDPatient must not have developed disease progression while being treated with this drug for this condition. ANDThe treatment must not exceed a total of 12 cycles of this drug for this indication, regardless of whether treatment was non-PBS or PBS-subsidised.	Compliance with Authority Required procedures
C18107	P18107	CN18107	Glofitamab	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Initial treatment (Cycle 1, Day 8)Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition. ANDPatient must be unsuitable for stem cell transplant. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have received or intend to receive a single pre-treatment dose of obinutuzumab for this indication. ANDThe treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components.Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.Glofitamab should be administered as an intravenous infusion according to the dose step-up schedule in Cycle 1 (2.5 mg on Day 8 and 10 mg on Day 15) leading to the recommended dosage of 30 mg on Day 1 of Cycles 2-12. Refer to the TGA approved Product Information.This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.	Compliance with Authority Required procedures
C18109	P18109	CN18109	Bimekizumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Face, hand, foot (new patient)Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis. ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition. ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s); and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18113	P18113	CN18113	DapagliflozinEmpagliflozin	Chronic heart failureThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug. ANDPatient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%. ANDPatient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy). ANDPatient must have documented evidence of at least one of the following: (i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause. ANDPatient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor.	Compliance with Authority Required procedures - Streamlined Authority Code 18113
C18114	P18114	CN18114	Budesonide with formoterol	AsthmaThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition.Must be treated by a respiratory physician. orMust be treated by a paediatrician.	Compliance with Authority Required procedures - Streamlined Authority Code 18114
C18116	P18116	CN18116	Bimekizumab	Severe chronic plaque psoriasisContinuing treatment, Whole bodyPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition. ANDPatient must have demonstrated an adequate response to treatment with this drug. ANDThe treatment must be as systemic monotherapy (other than methotrexate). ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18121	P18121	CN18121	Beclometasone with formoterol and glycopyrronium	Severe asthmaThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDPatient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique.Patient must be at least 18 years of age.Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta-2 agonist.	Compliance with Authority Required procedures - Streamlined Authority Code 18121
C18124	P18124	CN18124	Glofitamab	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Initial treatment (Cycle 1, Day 15)Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition. ANDPatient must be unsuitable for stem cell transplant. ANDPatient must have a WHO performance status of 2 or less. ANDPatient must have received or intend to receive a Cycle 1, Day 8 dose of glofitamab for this indication. ANDThe treatment must be given in combination with gemcitabine and oxaliplatin for the first 8 cycles unless the patient has a contraindication/toxicity necessitating discontinuation of one or both chemotherapy components.Glofitamab should be administered as an intravenous infusion according to the dose step-up schedule in Cycle 1 (2.5 mg on Day 8 and 10 mg on Day 15) leading to the recommended dosage of 30 mg on Day 1 of Cycles 2-12. Refer to the TGA approved Product Information.	Compliance with Authority Required procedures
C18125	P18125	CN18125	Opicapone	Parkinson diseaseThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. ANDThe treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination. ANDPatient must be experiencing fluctuations in motor function due to end-of-dose effect.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C18139	P18139	CN18139	Garadacimab	Chronic treatment of hereditary angioedema Types 1 or 2Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this condition as routine prophylaxis for hereditary angioedema prior to 1 April 2026; ANDPatient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment for this condition, orPatient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving non-PBS-subsidised treatment with this drug for this condition, orPatient must have received PBS-subsidised treatment with lanadelumab as routine prophylaxis for hereditary angioedema immediately prior to receiving non-PBS-subsidised treatment with this drug for this condition, orPatient must have received non-PBS-subsidised treatment with garadacimab via the VANGUARD open-label extension study as routine prophylaxis for hereditary angioedema; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab.Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrateThe baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating non-PBS-subsidised treatment must be provided at the time of submitting this application.For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.	Compliance with Authority Required procedures
C18140	P18140	CN18140	Lanadelumab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving lanadelumab; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.Must be treated by a clinical immunologist or a specialist allergist.Patient must be aged 12 years or older.	Compliance with Authority Required procedures
C18144	P18144	CN18144	AfliberceptRanibizumab	Branch retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography, orThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18145	P18145	CN18145	AfliberceptRanibizumab	Central retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography, orThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18146	P18146	CN18146	AfliberceptRanibizumab	Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must be due to pathologic myopia (PM); ANDThe condition must be diagnosed by optical coherence tomography, orThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18147	P18147	CN18147	Ranibizumab	Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must not be due to pathologic myopia; ANDThe condition must not be due to age-related macular degeneration; ANDThe condition must be diagnosed by optical coherence tomography, orThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18150	P18150	CN18150	Sacubitril with valsartan	Chronic heart failurePatient must be symptomatic with NYHA classes II, III or IV; ANDPatient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; ANDPatient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; ANDPatient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated, orPatient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; ANDThe treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.	Compliance with Authority Required procedures - Streamlined Authority Code 18150
C18217	P18217	CN18217	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyRecommencement of treatmentPatient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication.Patient must have had a lapse in growth hormone treatment; ANDThe treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. Recent growth data (height and weight, not older than three months).2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18223	P18223	CN18223	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyContinuing treatment as a reclassified patientPatient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously.The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment, orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment), orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment, orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; ANDPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels, orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment), or(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment.2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18224	P18224	CN18224	SomapacitanSomatrogon	Short stature and slow growthContinuing treatment as a reclassified patientPatient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously.The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; ANDPatient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment, orPatient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more; ANDPatient must be male and must not have a height greater than or equal to 167.7cm, orPatient must be female and must not have a height greater than or equal to 155.0cm.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18229	P18229	CN18229	Macrogol 3350	ConstipationPatient must have malignant neoplasia.	Compliance with Authority Required procedures - Streamlined Authority Code 18229
C18239	P18239	CN18239	Lanadelumab	Chronic treatment of hereditary angioedema Types 1 or 2Continuing preventative treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.Patient must be aged 12 years or older.Patients who have successfully transitioned to a lower dosing frequency should be reviewed every 6 months to ensure they continue to demonstrate a sustained responseFor the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.	Compliance with Authority Required procedures
C18241	P18241	CN18241	FedratinibMomelotinibRuxolitinib	Intermediate-1 risk myelofibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.Must be treated by a medical practitioner, orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 18241
C18242	P18242	CN18242	Atezolizumab	Locally advanced or metastatic non-small cell lung cancerInitial treatment - 3 weekly treatment regimenPatient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; ANDPatient must have a WHO performance status of 0 or 1; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; ANDThe condition must have progressed on or after prior platinum based chemotherapy, orThe condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 18242
C18243	P18243	CN18243	Atezolizumab	Locally advanced or metastatic non-small cell lung cancerInitial treatment - 4 weekly treatment regimenPatient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; ANDPatient must have a WHO performance status of 0 or 1; ANDThe treatment must be the sole PBS-subsidised therapy for this condition; ANDThe condition must have progressed on or after prior platinum based chemotherapy, orThe condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 18243
C18244	P18244	CN18244	Repotrectinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; ANDThe condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; ANDPatient must have a WHO performance status of 2 or less; ANDPatient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.The authority application must be via the Online PBS Authorities System or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include the following:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be documented in the patient's medical records:(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.	Compliance with Written Authority Required procedures
C18247	P18247	CN18247	Tafamidis	Transthyretin amyloid cardiomyopathyFirst PBS-subsidised prescription for this drugThe condition must have documented evidence of transthyretin precursor protein present; ANDPatient must have experienced at least one episode of hospitalisation that was a direct result of heart failure, orPatient must have clinical evidence of heart failure without hospitalisation that required treatment with a diuretic for improvement; ANDPatient must have/have had New York Heart Association class I heart failure at the time of commencing this drug, orPatient must have/have had New York Heart Association class II heart failure at the time of commencing this drug; ANDPatient must have an end-diastolic interventricular septal wall thickness of at least 12 mm on imaging; ANDPatient must have an estimated glomerular filtration rate (eGFR) greater than 25 mL/minute/1.73 m2.Must be treated by a medical practitioner who is any of the following: (i) a cardiologist, (ii) a consultant physician with experience in the management of amyloid disorders; this authority application must be sought by the same medical practitioner providing treatment.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Evidence of clinical findings to establish the diagnosis:In this authority application, confirm that there is documented evidence of transthyretin precursor protein through either (1) alone, or, both (2) and (3), from the list below:Confirm the following has been completed:(1) amyloid expert centre histology findings derived via immunohistochemistry or mass spectrometry, or(2) bone scintigraphy with grade 2-3 findingAND(3) Confirm that there are negative results for monoclonal protein on each of the following three tests:(a) serum immunofixation (also known as protein electrophoresis)(b) urine immunofixation(c) serum free light chains blood testState which of (1) to (3) above has been completed, as well as the:(i) date of the finding,(ii) imaging/pathology report number/code that links the finding to the patient,(iii) name of the amyloid expert centre in this authority application (if applicable).For end-diastolic interventricular septal wall thickness (at least 12 mm), confirm that:(i) imaging (echocardiogram or magnetic resonance imaging) has been undertaken; and(ii) that the imaging report is stored in the patient's medical records.State the date that the imaging was performed and the thickness (in mm) in this authority application.Where this authority application is to transition a patient from non-PBS-subsidised to PBS-subsidised supply (i.e. a 'grandfathered' patient), confirm the following:(i) the patient's heart failure has not worsened to persistent New York Heart Association Class III/IV heart failure while taking this drug.	Compliance with Written Authority Required procedures
C18249	P18249	CN18249	Upadacitinib	Non-radiographic axial spondyloarthritisInitial treatment - Initial 1 (New patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; ANDPatient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; ANDPatient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease, or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); ANDThe condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; ANDThe condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; ANDThe condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); ANDThe condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); ANDThe condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); ANDThe treatment must not exceed a maximum of 16 weeks with this drug under this restriction.Must be treated by a rheumatologist, orMust be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.The application must include details of the NSAIDs trialled, their doses and duration of treatment.If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and(b) C-reactive protein (CRP) level greater than 10 mg per L.The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18251	P18251	CN18251	Vismodegib	Metastatic or locally advanced basal cell carcinoma (BCC)Initial treatmentThe condition must be inappropriate for surgery; ANDThe condition must be inappropriate for curative radiotherapy; ANDPatient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition, orPatient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; ANDPatient must not receive more than 16 weeks of treatment under this restriction.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Inappropriate for surgery is defined as:(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures, or(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye, or requirement for limb amputation or free tissue transfer), or(iii) Medical contraindication to surgery.Inappropriate for curative radiotherapy is defined as:(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome, or(ii) Limitations due to location of tumour, or(iii) Limitations due to cumulative prior radiotherapy dose, or(iv) Progressive disease despite prior irradiation of locally advanced BCC.For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.	Compliance with Written Authority Required procedures
C18252	P18252	CN18252	Vismodegib	Metastatic or locally advanced basal cell carcinoma (BCC)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDThe condition must remain inappropriate for surgery; ANDThe condition must remain inappropriate for curative radiotherapy; ANDPatient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) Confirmation from the treating doctor that the disease has not progressed; and(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery, or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Inappropriate for surgery is defined as:(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures, or(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye, or requirement for limb amputation or free tissue transfer), or(iii) Medical contraindication to surgery.Inappropriate for curative radiotherapy is defined as:(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome, or(ii) Limitations due to location of tumour, or(iii) Limitations due to cumulative prior radiotherapy dose, or(iv) Progressive disease despite prior irradiation of locally advanced BCC.For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.	Compliance with Written Authority Required procedures
C18253	P18253	CN18253	Mavacamten	Symptomatic obstructive hypertrophic cardiomyopathyInitial treatment (covering the first 12 weeks of therapy)Patient must have confirmed left ventricular hypertrophy due to hypertrophic cardiomyopathy; ANDPatient must have maximal end-diastolic left ventricular wall thickness which is at least one of either: (i) no less than 15 mm; (ii) no less than 13 mm if patient has familial hypertrophic cardiomyopathy (at least one first degree relative with a diagnosis of hypertrophic cardiomyopathy); ANDPatient must have confirmed peak left ventricular outflow tract (LVOT) gradient of no less than 50 mm Hg which is measured either: (i) at rest; (ii) after provocation with at least one of (a) Valsalva manoeuvre, (b) exercise; ANDPatient must have a current left ventricular ejection fraction (LVEF) of no less than 55%; ANDPatient must have had prior treatments with each of a (i) beta-blocker and (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; ANDPatient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; ANDPatient must be symptomatic with NYHA classes II or III.Must be treated by a cardiologist, orMust be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.Patient must be at least 18 years of age.The authority application must be made in writing and must include all the following:(1) Details of the proposed prescription; and(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).(3) The details of the echocardiogram and/ or cardiac magnetic resonance imaging (MRI) report confirming the diagnosis of hypertrophic cardiomyopathy (HCM). State all the following:(a) the date, unique identifying number/code or provider number of the report;(b) the left ventricular wall thickness in millimetres (mm).(4) The details of a genotyping test report if the patient had been tested. State all the following:(a) the date, unique identifying number/code or provider number of the report;(b) if a gene has been identified that is associated with HCM;(c) if any first-degree family relative has a confirmed diagnosis of HCM.(5) The details of the LVOT gradient report. State all the following:(a) the date, unique identifying number/code or provider number of the report;(b) the measured LVOT gradient;(c) how the LVOT gradient was measured (rest, Valsalva manoeuvre or exercise).(6) NYHA status.(7) The current beta-blocker or non-dihydropyridine calcium channel blocker (either diltiazem or verapamil only) therapy if applicable.(8) Prior beta-blocker or non-dihydropyridine calcium channel blocker trials, including:(a) if the patient is currently taking beta-blocker therapy, state the previous therapy with non-dihydropyridine calcium channel blocker that was trialled confirming that it was not effective;(b) if the patient is currently taking non-dihydropyridine calcium channel blocker therapy, state the previous therapy with beta-blocker that was trialled confirming that it was not effective;(c) if there is contraindication or intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information, specify the details.All results and reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18257	P18257	CN18257	AtezolizumabDurvalumab	Extensive-stage small cell lung cancerInitial treatmentThe condition must be previously untreated; ANDPatient must not have previously received programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for any stage of small cell lung cancer; ANDPatient must have a WHO performance status of 0 or 1; ANDThe treatment must be in combination with etoposide and a platinum-based antineoplastic drug.	Compliance with Authority Required procedures - Streamlined Authority Code 18257
C18300	P18300	CN18300	Brentuximab vedotin	CD30 positive cutaneous T-cell lymphomaInitial treatmentPatient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; ANDPatient must have CD30 positivity of at least 3% of malignant cells; ANDPatient must have a diagnosis of mycosis fungoides, orPatient must have a diagnosis of Sezary syndrome, orPatient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; ANDPatient must have received prior systemic treatment for this condition; ANDThe condition must be relapsed or refractory; ANDThe treatment must not exceed 4 cycles under this restriction in a lifetime; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and(c) Date of commencement and completion of the most recent prior systemic treatment.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18301	P18301	CN18301	Brentuximab vedotin	CD30 positive peripheral T-cell lymphoma, non-cutaneous typeInitial treatmentPatient must have histological confirmation of CD30 expression in at least 3% of malignant cells; ANDThe treatment must be for first line therapy for this condition; ANDThe treatment must be for curative intent; ANDThe treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; ANDThe treatment must not be more than 6 treatment cycles under this restriction in a lifetime.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and(b) The date of initial diagnosis of Peripheral T-cell lymphoma.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18312	P18312	CN18312	Macrogol 3350	ConstipationPatient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; ANDThe condition must be unresponsive to other oral therapies.	Compliance with Authority Required procedures - Streamlined Authority Code 18312
C18313	P18313	CN18313	Macrogol 3350	ConstipationThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDPatient must be receiving palliative care.	Compliance with Authority Required procedures - Streamlined Authority Code 18313
C18314	P18314	CN18314	Macrogol 3350	Chronic constipationThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDThe condition must be inadequately controlled with first line interventions such as bulk-forming agents.	Compliance with Authority Required procedures - Streamlined Authority Code 18314
C18320	P18320	CN18320	Garadacimab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 3: New patient (transitioning from PBS-subsidised lanadelumab)Patient must have been receiving lanadelumab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab.Must be treated by a clinical immunologist or a specialist allergist.	Compliance with Authority Required procedures
C18321	P18321	CN18321	Garadacimab	Chronic treatment of hereditary angioedema Types 1 or 2Continuing preventative treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab.Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.	Compliance with Authority Required procedures
C18324	P18324	CN18324	FedratinibMomelotinibRuxolitinib	High risk and intermediate-2 risk myelofibrosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.Must be treated by a medical practitioner, orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 18324
C18326	P18326	CN18326	Atezolizumab	Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatment 1Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy.The condition must be non-squamous type non-small cell lung cancer (NSCLC); ANDPatient must not have previously been treated for this condition in the metastatic setting, orThe condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; ANDPatient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; ANDPatient must have a WHO performance status of 0 or 1; ANDThe condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.	Compliance with Authority Required procedures - Streamlined Authority Code 18326
C18329	P18329	CN18329	Sonidegib	Metastatic or locally advanced basal cell carcinoma (BCC)Initial treatmentThe condition must be inappropriate for surgery; ANDThe condition must be inappropriate for curative radiotherapy; ANDPatient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition, orPatient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; ANDPatient must not receive more than 16 weeks of treatment under this restriction.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Inappropriate for surgery is defined as:(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures, or(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye, or requirement for limb amputation or free tissue transfer), or(iii) Medical contraindication to surgery.Inappropriate for curative radiotherapy is defined as:(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome, or(ii) Limitations due to location of tumour, or(iii) Limitations due to cumulative prior radiotherapy dose, or(iv) Progressive disease despite prior irradiation of locally advanced BCC.For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.	Compliance with Written Authority Required procedures
C18333	P18333	CN18333	ArmodafinilModafinil	NarcolepsyInitial 1 - treatment of narcolepsy without cataplexyMust be treated by a qualified sleep medicine practitioner or neurologist.The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk, orThe treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; ANDPatient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; ANDPatient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT), orPatient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; ANDPatient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk:(a) a psychiatric disorder;(b) a cardiovascular disorder;(c) a history of substance abuse;(d) glaucoma;(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.The authority application must be made in writing and must include the following:(a) details of the proposed prescription; and(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and(c) details of the contraindication or intolerance to dexamfetamine sulfate; and(d) either:(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner, or(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.The polysomnography, MSLT or EEG test reports must be provided with the authority application.	Compliance with Written Authority Required procedures
C18334	P18334	CN18334	Azacitidine	Acute Myeloid LeukaemiaDose escalation therapy - Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have, in order to extend the dose schedule as per the TGA-approved Product Information, between 5% to 15% blasts in either the: (i) bone marrow, (ii) peripheral blood, in conjunction with clinical assessment, ANDPatient must not be receiving concomitant PBS-subsidised treatment with midostaurin.Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail:If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription, AND(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice)(c) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating the blast percentage.All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18335	P18335	CN18335	Certolizumab pegol	Non-radiographic axial spondyloarthritisInitial treatment - Initial 1 (New patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; ANDPatient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; ANDPatient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease, or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); ANDThe condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; ANDThe condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; ANDThe condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); ANDThe condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); ANDThe condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); ANDPatient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.Must be treated by a rheumatologist, orMust be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.The application must include details of the NSAIDs trialled, their doses and duration of treatment.If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and(b) C-reactive protein (CRP) level greater than 10 mg per L.The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18336	P18336	CN18336	Dexamethasone	Central retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography, orThe condition must be diagnosed by fluorescein angiography; ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors, orPatient must have failed prior treatment with VEGF inhibitors; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18337	P18337	CN18337	Eplerenone	Chronic heart failureThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDPatient must be symptomatic with NYHA classes II, III or IV; ANDPatient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; ANDPatient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; ANDPatient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated, orPatient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated.	Compliance with Authority Required procedures - Streamlined Authority Code 18337
C18338	P18338	CN18338	Sacubitril with valsartan	Chronic heart failureThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDPatient must be symptomatic with NYHA classes II, III or IV; ANDPatient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; ANDPatient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; ANDPatient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated, orPatient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; ANDThe treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.	Compliance with Authority Required procedures - Streamlined Authority Code 18338
C18359	P18359	CN18359	Mecasermin	Severe growth failure with primary insulin-like growth factor-1 deficiencyContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must have a bone age of less than 13.5 years (females), orPatient must have a bone age of less than 15.5 years (males); ANDThe treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); ANDThe condition must be responsive to this drug treatment as evidenced by each of: (i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application, orThe condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing.Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type, orMust be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician.Patient must be aged from 2 years up until their 18th birthday.The continuing treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) The patient's height (cm);(2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of:(i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response;(ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response;(3) The patient's weight (kg);(4) The patient's growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);(5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.Height, growth velocity and weight measurements must not be more than three months old at the time of application.Document growth improvements in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18363	P18363	CN18363	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyRecommencement of treatment as a reclassified patientPatient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone.Patient must have had a lapse in growth hormone treatment; ANDThe treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment, orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment), orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment, orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; ANDPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels, orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment), or(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment.2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18364	P18364	CN18364	Inotuzumab ozogamicin	Acute lymphoblastic leukaemiaInduction treatmentCareful monitoring of patients is required due to risk of developing hepatotoxicity, including life-threatening hepatic veno-occlusive disease, and the increased risk of post-haematopoietic stem cell transplant non-relapse mortality observed in patients treated with inotuzumab.The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; ANDPatient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; ANDPatient must not have received more than 1 line of salvage therapy; ANDPatient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; ANDThe condition must be CD22-positive; ANDThe condition must have more than 5% blasts in bone marrow; ANDThe treatment must not be more than 3 treatment cycles under this restriction in a lifetime.This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.The authority application must be made in writing and must include:(1) details of the proposed prescription(s);(2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and(3) evidence that the condition is CD22-positive; and(4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and(5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.The treatment must not exceed 0.8mg per m2 for the first dose of a treatment cycle (Day 1), and 0.5mg per m2 for subsequent doses (Days 8 and 15) within a treatment cycle.Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.	Compliance with Written Authority Required procedures
C18367	P18367	CN18367	SomapacitanSomatrogon	Short stature and slow growthRecommencement of treatmentPatient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication.Patient must have had a lapse in growth hormone treatment; ANDThe treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more; ANDPatient must be male and must not have a height greater than or equal to 167.7cm, orPatient must be female and must not have a height greater than or equal to 155.0cm.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. Recent growth data (height and weight, not older than three months).2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18370	P18370	CN18370	Nivolumab	Urothelial carcinomaThe treatment must be for each of: (i) adjuvant therapy that is/was initiated within 6 months of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition; ANDPatient must have received prior platinum containing neoadjuvant chemotherapy; ANDPatient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; ANDPatient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.Patient must be undergoing treatment with a dosing regimen as set out in the drug's Therapeutic Goods Administration (TGA) approved Product Information; ANDPatient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred.	Compliance with Authority Required procedures - Streamlined Authority Code 18370
C18374	P18374	CN18374	Macrogol 3350	Chronic constipationThe condition must be inadequately controlled with first line interventions such as bulk-forming agents.	Compliance with Authority Required procedures - Streamlined Authority Code 18374
C18375	P18375	CN18375	Macrogol 3350	ConstipationThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDPatient must be paraplegic, quadriplegic or have severe neurogenic impairment of bowel function; ANDThe condition must be unresponsive to other oral therapies.	Compliance with Authority Required procedures - Streamlined Authority Code 18375
C18376	P18376	CN18376	Macrogol 3350	Faecal impactionThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDThe condition must be inadequately controlled with first line interventions such as bulk-forming agents.	Compliance with Authority Required procedures - Streamlined Authority Code 18376
C18377	P18377	CN18377	Elranatamab	Relapsed or refractory multiple myelomaContinuing treatmentPatient must have previously received treatment with this drug for this condition; ANDPatient must have had progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody, orPatient must have been refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody; ANDPatient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition; ANDPatient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein), or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours, or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain, or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy, or(e) an increase in the size or number of lytic bone lesions (not including compression fractures), or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging), or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.	Compliance with Authority Required procedures
C18383	P18383	CN18383	Lapatinib	Metastatic (Stage IV) HER2 positive breast cancerInitial treatmentPatient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; ANDThe treatment must be in combination with capecitabine; ANDPatient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination, orPatient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination, orPatient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab, orPatient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; ANDThe treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH); and(ii) date of last treatment with a taxane and total number of cycles, or(iii) dates of treatment with trastuzumab and pertuzumab, or(iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab, or(v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumabIf intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.All reports must be documented in the patient's medical records.Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18384	P18384	CN18384	Larotrectinib	Solid tumours (of any type) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion where treatment with this drug is/was initiated in a childInitial treatmentThe condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; ANDThe condition must be metastatic disease, orThe condition must be both: (i) locally advanced, (ii) unresectable, orThe condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition.Patient must be/have been under 18 years of age (i.e. prior to their 18th birthday) at treatment initiation with this drug.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18385	P18385	CN18385	Larotrectinib	Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusionInitial treatmentThe condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; ANDThe condition must be a mammary analogue secretory carcinoma of the salivary gland confirmed through a pathology report from an Approved Pathology Authority (of any date), orThe condition must be a secretory breast carcinoma confirmed through a pathology report from an Approved Pathology Authority (of any date); ANDThe condition must be metastatic disease, orThe condition must be both: (i) locally advanced, (ii) unresectable, orThe condition must be both: (i) locally advanced, (ii) require disfiguring surgery/limb amputation to achieve complete surgical resection; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.Patient must not be undergoing treatment through this Initial treatment phase listing where the patient has developed disease progression while receiving this drug for this condition.Patient must be at least 18 years of age.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:(a) details of the pathology report substantiating the positive NTRK gene fusion. The recency of the pathology report may be of any date.(b) details of the pathology report establishing the carcinoma type (salivary gland/secretory breast carcinoma) being treated, if different to the pathology report provided to substantiate the NTRK gene fusion.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18388	P18388	CN18388	Givosiran	Chronic treatment of Acute Hepatic Porphyria (AHP)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must demonstrate improvement in the frequency or severity of AHP attacks from baseline while on treatment with this drug.Must be treated by a healthcare professional experienced in the management of porphyria or in consultation with a healthcare professional experienced in the management of porphyria.Patient must not have previously undergone a liver transplant.Patient must be at least 12 years of age.The number of AHP attacks while on treatment must be documented in the patient's medical records.At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient's weight, as per the TGA-approved Product Information.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18406	P18406	CN18406	Daratumumab	Newly diagnosed systemic light chain amyloidosisInitial treatment from week 0 to week 24The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; ANDThe condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation.Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); ANDPatient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsyIf the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18409	P18409	CN18409	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyInitial treatmentPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels, orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; ANDPatient must have a current height at or below the 1st percentile for age and sex, orPatient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child), orPatient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less, orPatient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must not have previously received treatment under the PBS S100 Growth Hormone Program; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a specialist or consultant physician in paediatric endocrinology, orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application, or(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex.2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.3. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18410	P18410	CN18410	SomapacitanSomatrogon	Short stature and slow growthInitial treatmentPatient must have a current height at or below the 1st percentile for age and sex; ANDPatient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child), orPatient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must not have previously received treatment under the PBS S100 Growth Hormone Program; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more; ANDPatient must be male and must not have a height greater than or equal to 167.7 cm, orPatient must be female and must not have a height greater than or equal to 155.0 cm; ANDPatient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm, orPatient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm.Must be treated by a specialist or consultant physician in paediatric endocrinology, orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application.2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.3. Confirmation of the patient's maturational or constitutional delay status.4. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1st adult height percentile.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18411	P18411	CN18411	SomapacitanSomatrogon	Short stature and slow growthChange of drugPatient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks, orPatient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated, orPatient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more; ANDPatient must be male and must not have a height greater than or equal to 167.7cm, orPatient must be female and must not have a height greater than or equal to 155.0cm.Must be treated by a specialist or consultant physician in paediatric endocrinology, orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Definition:An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:(a) the 50th percentile growth velocity for bone age;(b) an increase in height standard deviation score for chronological age;(c) a minimum growth velocity of 4 cm per year;(d) a mid-parental height standard deviation score.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.Where growth data has been supplied within 3 months of this authority application, do not resupply this data.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18413	P18413	CN18413	Pembrolizumab	Resectable locally advanced squamous cell carcinoma of the oral cavity, pharynx or larynxPatient must have stage III-IVB squamous cell carcinoma of the oral cavity, pharynx or larynx; ANDPatient must have tumour(s) that are resectable as assessed by the treating clinician, orPatient must have undergone surgical resection; ANDPatient must have a WHO performance status of 1 or less; ANDPatient must not have experienced disease recurrence or progression while being treated with this drug for this condition; ANDThe treatment must be commenced as neoadjuvant therapy and continued in combination with radiation therapy with or without chemotherapy after surgical resection, orThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; ANDThe treatment must not exceed a total of 12 cumulative months, either as: (i) 17 doses (based on a 3-weekly dose regimen), (ii) 8 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless of if it was PBS/non-PBS subsidised.Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions, orPatient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 18413
C18414	P18414	CN18414	Macrogol 3350	ConstipationPatient must be receiving palliative care.	Compliance with Authority Required procedures - Streamlined Authority Code 18414
C18415	P18415	CN18415	Macrogol 3350	Faecal impactionThe condition must be inadequately controlled with first line interventions such as bulk-forming agents.	Compliance with Authority Required procedures - Streamlined Authority Code 18415
C18416	P18416	CN18416	Macrogol 3350	ConstipationThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; ANDPatient must have malignant neoplasia.	Compliance with Authority Required procedures - Streamlined Authority Code 18416
C18417	P18417	CN18417	Durvalumab	Urothelial carcinomaInitial treatment - neoadjuvant settingPatient must be initiating treatment with this drug for this condition, orPatient must be transitioning from non-PBS to PBS-subsidised treatment with this drug for this condition; ANDThe condition must not have previously been treated with systemic therapy for muscle-invasive bladder cancer at the time this drug was initiated for this condition; ANDThe treatment must be once in a lifetime with this drug for this condition; ANDThe condition must be of muscle-invasive type disease with both: (i) clinical tumour stage of either T2, T3 or T4a, (ii) nodal status of up to stage N1; ANDThe treatment must be for neoadjuvant use in a patient preparing for radical cystectomy; ANDPatient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; ANDThe treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information).Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 4 cycles from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.	Compliance with Authority Required procedures - Streamlined Authority Code 18417
C18424	P18424	CN18424	Lanadelumab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 3: New patient (transitioning from PBS-subsidised garadacimab)Patient must have been receiving garadacimab through the PBS as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.Must be treated by a clinical immunologist or a specialist allergist.Patient must be aged 12 years or older.	Compliance with Authority Required procedures
C18425	P18425	CN18425	MogamulizumabVorinostat	Cutaneous T-cell lymphomaInitial treatmentPatient must have received systemic treatment with chemotherapy; ANDPatient must demonstrate relapsed or chemotherapy-refractory disease; ANDPatient must be ineligible for stem cell transplant; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18428	P18428	CN18428	Dexamethasone	Branch retinal vein occlusion with macular oedemaInitial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography, orThe condition must be diagnosed by fluorescein angiography; ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors, orPatient must have failed prior treatment with VEGF inhibitors; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18429	P18429	CN18429	Golimumab	Non-radiographic axial spondyloarthritisInitial treatment - Initial 1 (New patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; ANDPatient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; ANDPatient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease, or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); ANDThe condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; ANDThe condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; ANDThe condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); ANDThe condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); ANDThe condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); ANDThe treatment must not exceed a maximum of 16 weeks with this drug under this restriction.Must be treated by a rheumatologist, orMust be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.The application must include details of the NSAIDs trialled, their doses and duration of treatment.If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and(b) C-reactive protein (CRP) level greater than 10 mg per L.The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18444	P18444	CN18444	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyChange of drugPatient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks, orPatient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated, orPatient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a specialist or consultant physician in paediatric endocrinology, orMust be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Definition:An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:(a) the 50th percentile growth velocity for bone age;(b) an increase in height standard deviation score for chronological age;(c) a minimum growth velocity of 4 cm per year;(d) a mid-parental height standard deviation score.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.Where growth data has been supplied within 3 months of this authority application, do not resupply this data.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18445	P18445	CN18445	SomapacitanSomatrogon	Short stature and slow growthContinuing treatmentPatient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication.Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; ANDPatient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply, orPatient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply, orPatient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply, orPatient must have achieved a mid-parental height standard deviation score following the most recent supply, orThe treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more; ANDPatient must be male and must not have a height greater than or equal to 167.7cm, orPatient must be female and must not have a height greater than or equal to 155.0cm.Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.3. The final adult height (in cm) of the patient's mother and father (where available).If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18446	P18446	CN18446	SomapacitanSomatrogon	Short stature and slow growthTransitioning from non-PBS to PBS-subsidised supply - Grandfather arrangementsPatient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime.The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; ANDPatient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment, orPatient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a height greater than or equal to 167.7 cm, orPatient must be female and must not have a height greater than or equal to 155.0 cm; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment, or(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment.2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18447	P18447	CN18447	SomapacitanSomatrogon	Short stature and slow growthRecommencement of treatment as a reclassified patientPatient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone.Patient must have had a lapse in growth hormone treatment; ANDThe treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; ANDPatient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment, orPatient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a height greater than or equal to 167.7 cm, orPatient must be female and must not have a height greater than or equal to 155.0 cm; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.2. Recent growth data (height and weight, not older than three months).3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18449	P18449	CN18449	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyContinuing treatmentPatient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication.Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply, orPatient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply, orPatient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply, orPatient must have achieved a mid-parental height standard deviation score following the most recent supply, orThe treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.3. The final adult height (in cm) of the patient's mother and father (where available).If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18454	P18454	CN18454	Garadacimab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; ANDPatient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab.Must be treated by a clinical immunologist or a specialist allergist.For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrateThe baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.	Compliance with Authority Required procedures
C18455	P18455	CN18455	Cemiplimab	Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatment - 3 weekly treatment regimenPatient must not have previously been treated for this condition in the metastatic setting, orThe condition must have progressed after treatment with a prior targeted therapy PBS-listed for this condition; ANDPatient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; ANDPatient must have a WHO performance status of 0 or 1; ANDThe condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; ANDThe treatment must not exceed a total of 7 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 18455
C18460	P18460	CN18460	Givosiran	Chronic treatment of Acute Hepatic Porphyria (AHP)Initial treatmentPatient must have a confirmed diagnosis of AHP based on clinical features; ANDPatient must have a previous result that showed a 4 times greater than the upper limit of normal (ULN) on one of the following tests: (i) urinary porphobilinogen, (ii) plasma porphobilinogen, (iii) delta-aminolevulinic acid; ANDPatient must have had at least 2 porphyria attacks (requiring hospitalisation, presentation at an emergency department, or medical intervention via a porphyria clinic) within the 6 months prior to: (i) commencement of this drug, or (ii) prophylactic treatment with gonadotropin-releasing hormone analogues or hemin; ANDPatient must not have previously undergone a liver transplant; ANDThe treatment must be initiated under the supervision of a healthcare professional experienced in the management of porphyria.Patient must be at least 12 years of age.For the purposes of administering this restriction, clinical features to confirm a diagnosis of AHP can include but are not limited to acute attacks of: abdominal, back, chest, extremities, and/or limb pain.At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient's weight, as per the TGA-approved Product Information.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) The baseline number of porphyria attacks within a defined 6-month period [dates of the 6-month period must be included].(2) Pathology measurements that indicate 4 times greater than the ULN of one of the following tests:(i) urinary porphobilinogen;(ii) plasma porphobilinogen;(iii) delta-aminolevulinic acid.Date of pathology report and unique identifying number/code that links the pathology result to the individual patient must be included.(3) Current weight of the patient.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18461	P18461	CN18461	Eplerenone	Chronic heart failurePatient must be symptomatic with NYHA classes II, III or IV; ANDPatient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; ANDPatient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance; ANDPatient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated, orPatient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated.	Compliance with Authority Required procedures - Streamlined Authority Code 18461
C18475	P18475	CN18475	Mecasermin	Severe growth failure with primary insulin-like growth factor-1 deficiencyInitial treatmentThe condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5th percentile adjusted for each of: (i) age, (ii) gender; ANDThe condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient's height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of: (i) age, (ii) gender; ANDPatient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); ANDThe condition must not be caused by growth hormone deficiency; ANDPatient must have a bone age of less than 13.5 years (females), orPatient must have a bone age of less than 15.5 years (males); ANDThe condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following: (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; ANDThe treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing).Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type, orMust be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician.Patient must be aged from 2 years up until their 18th birthday.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.The initial treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include the following:(1) Insulin-like growth factor-1 deficiency:State each of: (a) the patient's most recent basal IGF-1 level measured (ng/mL), (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider;(2) Short stature:State the patient's height (cm);(3) Normal growth hormone levels:State the patient's most recent growth hormone level measurement (mcg/L) - this figure must be greater than 6.6 mcg/L;(4) Bone age: (where the patient has a chronological age of at least 2.5 years):State each of: (a) the patient's bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application;(5) The patient's weight (kg);(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.Height, growth velocity and weight measurements must not be more than three months old at the time of application.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18477	P18477	CN18477	SomapacitanSomatrogon	Short stature associated with biochemical growth hormone deficiencyTransitioning from non-PBS to PBS-subsidised supply - Grandfather arrangementsPatient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime.The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; ANDPatient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment, orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment), orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment, orPatient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; ANDPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency), orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels, orPatient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; ANDPatient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; ANDPatient must not have an active tumour or evidence of tumour growth or activity; ANDPatient must be male and must not have a bone age of 15.5 years or more, orPatient must be female and must not have a bone age of 13.5 years or more.Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology, orMust be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; ANDPatient must be undergoing treatment for the stated indication with only one growth hormone at any given time.An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment), or(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment.2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.	Compliance with Written Authority Required procedures
C18481	P18481	CN18481	Durvalumab	Limited-stage small cell lung cancerPatient must have received chemoradiation therapy (CRT); ANDThe condition must not have progressed following CRT; ANDPatient must have had a WHO performance status of no greater than 1 at treatment initiation with this drug for this condition; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; ANDThe treatment must not exceed 24 months in total for this condition, measured from the initial dose, or must not extend beyond disease progression, whichever comes first.	Compliance with Authority Required procedures - Streamlined Authority Code 18481
C18482	P18482	CN18482	Durvalumab	Urothelial carcinomaContinuing treatment - adjuvant settingPatient must have previously received PBS-subsidised neoadjuvant treatment with this drug in combination with gemcitabine plus cisplatin for this condition, orPatient must be both: (i) transitioning from existing non-PBS to PBS-subsidised treatment with this drug for this condition, (ii) previously treated in combination with cisplatin and gemcitabine as neoadjuvant treatment for this condition; ANDPatient must have undergone radical cystectomy; ANDThe treatment must be for adjuvant therapy that is/was initiated within 6 months of radical cystectomy for this condition; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 8 cycles for this condition from the first administered dose following radical cystectomy, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Treatment with this drug for this condition must not exceed 12 treatment cycles (neoadjuvant and adjuvant) in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 18482
C18484	P18484	CN18484	Garadacimab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 2: New patient (commencing from National Blood Authority-funded C1-INH)Patient must have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema immediately prior to receiving this drug; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab.Must be treated by a clinical immunologist or a specialist allergist.	Compliance with Authority Required procedures
C18490	P18490	CN18490	Brolucizumab	Subfoveal choroidal neovascularisation (CNV)Initial treatmentMust be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.The condition must be due to age-related macular degeneration (AMD); ANDPatient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with: 1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab; ANDThe treatment must be the sole PBS-subsidised therapy for this condition; ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:(1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription; and(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).All reports must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18491	P18491	CN18491	Decitabine with cedazuridine	Chronic Myelomonocytic LeukaemiaInitial treatmentThe condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; ANDThe condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.No more than 3 cycles will be authorised under this restriction in a patient's lifetime.The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology AuthorityAll reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following reports must be documented in the patient's medical records:(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and(b) full blood examination report	Compliance with Written Authority Required procedures
C18495	P18495	CN18495	Semaglutide	Diabetes mellitus type 2Subsequent PBS-prescriptions for any GLP-1 receptor agonistThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.Patient must not be undergoing concomitant PBS-subsidised treatment for type 2 diabetes mellitus with any of: an SGLT2 inhibitor, a DPP4 inhibitor, another GLP-1 receptor agonist.	Compliance with Authority Required procedures - Streamlined Authority Code 18495
C18496	P18496	CN18496	Garadacimab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis), Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) or Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis) restriction to complete 24 weeks treatment, orPatient must have received insufficient therapy with this drug for this condition under the Initial 2: New patient (commencing from National Blood Authority-funded C1-INH) restriction to complete 24 weeks treatment, orPatient must have received insufficient therapy with this drug for this condition under the Initial 3: New patient (transitioning from PBS-subsidised lanadelumab) restriction to complete 24 weeks treatment; ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) lanadelumab.Must be treated by a clinical immunologist or a specialist allergist.For the purposes of administering this restriction, an adequate response is a reduction of the baseline number of acute attacks of hereditary angioedema of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrate. The details of the reduction must be documented in the patient's medical records for auditing purposes.	Compliance with Authority Required procedures
C18498	P18498	CN18498	Lanadelumab	Chronic treatment of hereditary angioedema Types 1 or 2Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; ANDPatient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; ANDThe treatment must not be used in combination with either: (i) a C1-esterase inhibitor concentrate, or (ii) garadacimab.Must be treated by a clinical immunologist or a specialist allergist.Patient must be aged 12 years or older.For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii) C1-esterase inhibitor concentrateThe baseline measurement of the number of treated acute attacks of hereditary angioedema within the 6 months prior to initiating treatment must be provided at the time of submitting this application.	Compliance with Authority Required procedures
C18499	P18499	CN18499	Secukinumab	Non-radiographic axial spondyloarthritisInitial treatment - Initial 1 (New patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; ANDPatient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; ANDPatient must have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; ANDPatient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease, or (f) positive for Human Leukocyte Antigen B27 (HLA-B27); ANDThe condition must not be radiographically evidenced on plain x-ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; ANDThe condition must be non-radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; ANDThe condition must be sacroiliitis with active inflammation and/or oedema on non-contrast Magnetic Resonance Imaging (MRI); ANDThe condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); ANDThe condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); ANDPatient must not receive more than 20 weeks of treatment under this restriction.Must be treated by a rheumatologist, orMust be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.State in the application whether a loading dose regimen is intended or not.Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.The application must include details of the NSAIDs trialled, their doses and duration of treatment.If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reason a higher dose cannot be used.If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of the contraindication.If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale; and(b) C-reactive protein (CRP) level greater than 10 mg per L.The baseline BASDAI score and CRP level must be determined at the completion of the 3-month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The baseline BASDAI score and CRP level must also be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18500	P18500	CN18500	Sonidegib	Metastatic or locally advanced basal cell carcinoma (BCC)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition; ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; ANDThe condition must remain inappropriate for surgery; ANDThe condition must remain inappropriate for curative radiotherapy; ANDPatient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) Confirmation from the treating doctor that the disease has not progressed; and(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery, or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Inappropriate for surgery is defined as:(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures, or(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye, or requirement for limb amputation or free tissue transfer), or(iii) Medical contraindication to surgery.Inappropriate for curative radiotherapy is defined as:(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome, or(ii) Limitations due to location of tumour, or(iii) Limitations due to cumulative prior radiotherapy dose, or(iv) Progressive disease despite prior irradiation of locally advanced BCC.For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.	Compliance with Written Authority Required procedures
C18503	P18503	CN18503	Brentuximab vedotin	CD30 positive systemic anaplastic large cell lymphomaInitial treatmentThe treatment must be for curative intent; ANDPatient must have undergone appropriate prior front-line curative intent chemotherapy; ANDPatient must demonstrate relapsed or chemotherapy-refractory disease; ANDPatient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; ANDThe treatment must not exceed 4 cycles under this restriction.Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and(c) Dates of commencement and completion of front-line curative intent chemotherapy; and(d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; and(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18507	P18507	CN18507	Lamotrigine	Bipolar disorderMust be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C18508	P18508	CN18508	Lamotrigine	Bipolar disorderThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C18513	P18513	CN18513	Apixaban	Deep vein thrombosisPatient must have confirmed acute symptomatic deep vein thrombosis, ANDPatient must not have symptomatic pulmonary embolism.	Compliance with Authority Required procedures - Streamlined Authority Code 18513
C18515	P18515	CN18515	Trifluridine with tipiracil	Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junctionInitial treatmentPatient must have a WHO performance status of 1 or less, ANDPatient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 18515
C18516	P18516	CN18516	Fruquintinib	Metastatic colorectal cancerInitial PBS-subsidised treatmentPatient must have/had a WHO performance status of 1 or less, prior to initiation of treatment with this drug for this condition, ANDPatient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; orPatient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) untreated with this drug at the time that non-PBS-subsidised supply was commenced, (iii) free of disease progression since commencing non-PBS-subsidised supply, ANDPatient must have been previously treated with or not considered a candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.The patient's WHO performance status must be documented in the patient's medical records at the time the treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 18516
C18518	P18518	CN18518	Trifluridine with tipiracil	Metastatic colorectal cancerInitial treatmentPatient must have a WHO performance status of 1 or less, ANDPatient must have been previously treated with or not considered a candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 18518
C18520	P18520	CN18520	Fruquintinib	Metastatic colorectal cancerContinuing treatmentThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must have previously been treated with PBS-subsidised treatment with this drug for this condition, ANDPatient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 18520
C18522	P18522	CN18522	Apixaban	Pulmonary embolismPatient must have confirmed acute symptomatic pulmonary embolism.	Compliance with Authority Required procedures - Streamlined Authority Code 18522
C18525	P18525	CN18525	Apixaban	Deep vein thrombosisThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have confirmed acute symptomatic deep vein thrombosis, ANDPatient must not have symptomatic pulmonary embolism.	Compliance with Authority Required procedures - Streamlined Authority Code 18525
C18527	P18527	CN18527	Apixaban	Pulmonary embolismThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have confirmed acute symptomatic pulmonary embolism.	Compliance with Authority Required procedures - Streamlined Authority Code 18527
C18529	P18529	CN18529	IxekizumabSecukinumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18530	P18530	CN18530	GuselkumabIxekizumabRisankizumabSecukinumabTildrakizumab	Severe chronic plaque psoriasisBalance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, footPatient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; orPatient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18534	P18534	CN18534	AdalimumabBaricitinibTocilizumabTofacitinibUpadacitinib	Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; orPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18535	P18535	CN18535	Adalimumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Face, hand, foot (new patient)Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18537	P18537	CN18537	Adalimumab	Severe chronic plaque psoriasisBalance of supply - Continuing treatment, Whole body or Continuing treatment, Face, hand, footPatient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; orPatient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; orPatient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; orPatient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions, ANDThe treatment must be as systemic monotherapy (other than methotrexate).Patient must be at least 18 years of age.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18538	P18538	CN18538	Adalimumab	Severe chronic plaque psoriasisSubsequent continuing treatment, Whole bodyPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18540	P18540	CN18540	Adalimumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18542	P18542	CN18542	Adalimumab	Severe chronic plaque psoriasisFirst continuing treatment, Whole bodyPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18543	P18543	CN18543	Adalimumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18544	P18544	CN18544	Adalimumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Whole body (new patient)Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18545	P18545	CN18545	Adalimumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18547	P18547	CN18547	Adalimumab	Severe chronic plaque psoriasisFirst continuing treatment, Face, hand, footPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18549	P18549	CN18549	Adalimumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; orPatient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; orThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Active joints are defined as:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measurements must be no more than 4 weeks old at the time of this application.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C18550	P18550	CN18550	Adalimumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after break in biological medicine of less than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years, ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
C18552	P18552	CN18552	Adalimumab	Severe active juvenile idiopathic arthritisFirst continuing treatmentMust be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
C18557	P18557	CN18557	Adalimumab	Severe active juvenile idiopathic arthritisBalance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment, ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
C18560	P18560	CN18560	AbataceptGolimumab	Severe active rheumatoid arthritisFirst continuing treatmentMust be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment under this restriction, ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18562	P18562	CN18562	AdalimumabBaricitinibTocilizumabTofacitinibUpadacitinib	Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Written Authority Required procedures
C18565	P18565	CN18565	Tocilizumab	Severe active juvenile idiopathic arthritisBalance of supply - Initial treatment - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment, ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
C18571	P18571	CN18571	GuselkumabRisankizumabSecukinumabTildrakizumab	Severe chronic plaque psoriasisContinuing treatment, Whole bodyPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18575	P18575	CN18575	Risankizumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Whole body (new patient)Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18576	P18576	CN18576	Risankizumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18579	P18579	CN18579	Blinatumomab	Acute lymphoblastic leukaemiaConsolidation treatment of relapsed or refractory B-precursor cell ALLCareful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.Patient must have previously received PBS-subsidised induction treatment with this drug for relapsed or refractory B-precursor cell ALL, ANDPatient must have achieved a complete remission; orPatient must have achieved a complete remission with partial haematological recovery, ANDThe treatment must not be more than 3 treatment cycles under this restriction in a lifetime, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.	Compliance with Authority Required procedures
C18582	P18582	CN18582	IxekizumabSecukinumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18583	P18583	CN18583	GuselkumabRisankizumabSecukinumabTildrakizumab	Severe chronic plaque psoriasisContinuing treatment, Face, hand, footPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18584	P18584	CN18584	AbataceptAdalimumabBaricitinibGolimumabTocilizumabTofacitinibUpadacitinib	Severe active rheumatoid arthritisBalance of supply - Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment, ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
C18587	P18587	CN18587	Adalimumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18590	P18590	CN18590	Adalimumab	Severe chronic plaque psoriasisBalance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18593	P18593	CN18593	Adalimumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; orPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) an active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measurements must be no more than 4 weeks old at the time of initial application.If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C18594	P18594	CN18594	Adalimumab	Severe active juvenile idiopathic arthritisBalance of supply - Continuing treatmentMust be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.	Compliance with Authority Required procedures
C18596	P18596	CN18596	AbataceptGolimumab	Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; orThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints, ANDPatient must not receive more than 16 weeks of treatment under this restriction, ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18598	P18598	CN18598	Certolizumab pegol	Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Written Authority Required procedures
C18601	P18601	CN18601	Tocilizumab	Severe active rheumatoid arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18604	P18604	CN18604	AdalimumabBaricitinibTocilizumabTofacitinibUpadacitinib	Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; orThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18608	P18608	CN18608	Guselkumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Whole body (new patient)Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 20 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18610	P18610	CN18610	Risankizumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18614	P18614	CN18614	Tildrakizumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Whole body (new patient)Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18615	P18615	CN18615	Acalabrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Initial treatment (treatment cycles 1 to 2 inclusive) in first-line therapyThe condition must be untreated with drug treatment at the time of the first dose of this drug; orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be initiated as monotherapy, with the intention of use in combination with venetoclax from cycle 3 to 14, ANDThe treatment must not be in combination with obinutuzumab.	Compliance with Authority Required procedures
C18618	P18618	CN18618	Obinutuzumab	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapyThe condition must be untreated, ANDThe treatment must be in combination with PBS-subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses), ANDThe treatment must not be in combination with venetoclax.	Compliance with Authority Required procedures - Streamlined Authority Code 18618
C18623	P18623	CN18623	DapagliflozinEmpagliflozin	Chronic kidney diseaseThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug, ANDPatient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug, ANDPatient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; orPatient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug, ANDPatient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant, ANDPatient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor, ANDPatient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 18623
C18624	P18624	CN18624	DapagliflozinEmpagliflozin	Chronic kidney diseasePatient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of: (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug, ANDPatient must have an estimated glomerular filtration rate of between 20 to 90 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug, ANDPatient must have an estimated glomerular filtration rate of between 45 to 90 mL/min/1.73 m2 inclusive, with a urinary albumin to creatinine ratio of at least 200 mg/g (22.6 mg/mmol) prior to initiating treatment with this drug; orPatient must have an estimated glomerular filtration rate of between 20 to 45 mL/min/1.73 m2 inclusive, with any level of urinary albumin to creatinine ratio prior to initiating treatment with this drug, ANDPatient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant, ANDPatient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor, ANDPatient must be stabilised, for at least 4 weeks, on either: (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.	Compliance with Authority Required procedures - Streamlined Authority Code 18624
C18625	P18625	CN18625	Mavacamten	Symptomatic obstructive hypertrophic cardiomyopathyFirst continuing treatment (until at least 6 months on optimal dose is achieved)Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction, ANDPatient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy, ANDPatient must have a current left ventricular ejection fraction (LVEF) of no less than 50%, ANDPatient must be titrating mavacamten treatment until optimal dose is achieved; orPatient must be continuing mavacamten treatment to reach at least 6 months on the optimal dose prior to assessing the response.Must be treated by a cardiologist. orMust be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy.The assessment of response must be conducted after at least 6 months on optimal dose to determine the patient's eligibility for maintenance treatment. Where an assessment is not undertaken, the patient will not be eligible for ongoing treatment. This treatment phase listing intends to provide up to 36 weeks of treatment in 3 treatment courses.For the purposes of this restriction, an adequate response to treatment is defined as: an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient.	Compliance with Authority Required procedures
C18631	P18631	CN18631	Adalimumab	Severe active juvenile idiopathic arthritisSubsequent continuing treatmentMust be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.	Compliance with Written Authority Required procedures
C18633	P18633	CN18633	AbataceptGolimumab	Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; orPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application, ANDPatient must not receive more than 16 weeks of treatment under this restriction, ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18634	P18634	CN18634	Certolizumab pegol	Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; orThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints, ANDPatient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18635	P18635	CN18635	AbataceptGolimumab	Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition. orPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication. ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition. ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times. ANDPatient must not receive more than 16 weeks of treatment under this restriction. ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Written Authority Required procedures
C18638	P18638	CN18638	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
C18639	P18639	CN18639	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Must be treated by a paediatric rheumatologist; orPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab.Patient must be under 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
C18643	P18643	CN18643	Guselkumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Face, hand, foot (new patient)Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 20 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18644	P18644	CN18644	Ixekizumab	Severe chronic plaque psoriasisBalance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18645	P18645	CN18645	Ixekizumab	Severe chronic plaque psoriasisContinuing treatment, Whole bodyPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s), AND(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18646	P18646	CN18646	Risankizumab	Severe chronic plaque psoriasisBalance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18647	P18647	CN18647	IxekizumabSecukinumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Face, hand, foot (new patient)Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18648	P18648	CN18648	Venetoclax	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First continuing treatment (treatment cycles 4 to 8 inclusive) of first-line therapy with acalabrutinibPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be in combination with acalabrutinib, ANDThe treatment must not be in combination with obinutuzumab, ANDThe treatment must cease upon disease progression.	Compliance with Authority Required procedures
C18650	P18650	CN18650	Blinatumomab	Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)Initial treatment of newly-diagnosed Pre-B-cell ALL in the consolidation phaseMust be treated by a physician experienced in the treatment of haematological malignancies.Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, ANDThe condition must not be present in the central nervous system or testis, ANDPatient must have achieved complete remission following intensive combination chemotherapy for acute lymphoblastic leukaemia (ALL); orPatient must have Philadelphia chromosome positive ALL, and both (i) have achieved complete remission following combination therapy with a tyrosine kinase inhibitor and corticosteroids (ii) be unable to tolerate chemotherapy, ANDThe treatment must not be more than 2 treatment cycles under this restriction in a lifetime.According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle.For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form, AND(3) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application, AND(4) the date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; or(5) the date of the course of combination therapy with a tyrosine kinase inhibitor and corticosteroid for Philadelphia chromosome positive patients.	Compliance with Written Authority Required procedures
C18651	P18651	CN18651	Blinatumomab	Acute lymphoblastic leukaemiaInduction treatment - balance of supply - relapsed or refractory B-precursor cell ALLCareful monitoring of patients is required due to risk of developing life-threatening Cytokine Release Syndrome, neurological toxicities and reactivation of John Cunningham virus (JC) viral infection.The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, ANDThe condition must not be present in the central nervous system or testis, ANDPatient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.	Compliance with Authority Required procedures
C18653	P18653	CN18653	IxekizumabSecukinumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Whole body (new patient)Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18659	P18659	CN18659	Infliximab	Severe active rheumatoid arthritisInitial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being madeMust be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine, ANDPatient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The PBS administrator will confirm that:(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.	Compliance with Written Authority Required procedures
C18661	P18661	CN18661	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years, ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
C18662	P18662	CN18662	Infliximab	Severe chronic plaque psoriasisInitial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being madeMust be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine, ANDPatient must be undergoing treatment with this benefit where: (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved.Patient must be at least 18 years of age.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The PBS administrator will confirm that:(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.	Compliance with Written Authority Required procedures
C18664	P18664	CN18664	Risankizumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18665	P18665	CN18665	Venetoclax	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapyPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must cease upon disease progression; orThe treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first, ANDThe treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses), ANDThe treatment must not be in combination with acalabrutinib.	Compliance with Authority Required procedures
C18666	P18666	CN18666	Venetoclax	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Initial treatment in first-line therapy with acalabrutinib - Dose titration (cycle 3)The condition must be untreated with venetoclax at the time of the first dose of this drug; orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be in combination with acalabrutinib, ANDThe treatment must not be in combination with obinutuzumab.	Compliance with Authority Required procedures
C18667	P18667	CN18667	Venetoclax	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Second and final continuing treatment (treatment cycles 9 to 14 inclusive) of first-line therapy with acalabrutinibPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be in combination with acalabrutinib, ANDThe treatment must not be in combination with obinutuzumab, ANDThe treatment must not exceed 12 cycles in total with this drug, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first.	Compliance with Authority Required procedures
C18669	P18669	CN18669	Adalimumab	Severe chronic plaque psoriasisSubsequent continuing treatment, Face, hand, footPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet and the face, hand, foot area diagrams including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18670	P18670	CN18670	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; orPatient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; orThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Active joints are defined as:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measurements must be no more than 4 weeks old at the time of this application.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C18671	P18671	CN18671	Upadacitinib	Severe active rheumatoid arthritisFirst continuing treatmentMust be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18672	P18672	CN18672	Guselkumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 20 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18677	P18677	CN18677	Risankizumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Face, hand, foot (new patient)Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18680	P18680	CN18680	Tildrakizumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18681	P18681	CN18681	Tildrakizumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18682	P18682	CN18682	Tildrakizumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18683	P18683	CN18683	Venetoclax	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule)The condition must be untreated with drug treatment at the time of the first dose of this drug; orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses), ANDThe treatment must not be in combination with acalabrutinib.	Compliance with Authority Required procedures
C18684	P18684	CN18684	Acalabrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised supply in first-line therapyPatient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2026, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe condition must have been untreated with drug treatment at the time of the first dose of this drug; orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line treatment of CLL/SLL prior to initiating non-PBS-subsidised treatment with this drug for this condition, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be in combination with venetoclax as continuing treatment for this condition (treatment cycles 3 to 14 inclusive); orThe treatment must be as monotherapy for initial treatment of this condition (treatment cycles 1 to 2 inclusive), ANDThe treatment must not be in combination with obinutuzumab, ANDThe treatment must not exceed 14 cycles in total with this drug, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first.A patient may qualify for PBS-subsidised treatment under this restriction once only.For continuing PBS-subsidised treatment, a 'Grandfathered' patient must qualify under the next relevant treatment phase.	Compliance with Authority Required procedures
C18685	P18685	CN18685	Obinutuzumab	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapyThe condition must be untreated, ANDThe treatment must be in combination with PBS-subsidised venetoclax, ANDThe treatment must not be in combination with acalabrutinib.	Compliance with Authority Required procedures - Streamlined Authority Code 18685
C18686	P18686	CN18686	Acalabrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First line drug treatment of this indication - in combination with obinutuzumabThe condition must be untreated with drug treatment at the time of the first dose of this drug; orPatient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL, ANDThe treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition, ANDThe treatment must be initiated as a monotherapy for 1 Cycle with treatment in combination with obinutuzumab from Cycle 2 to 7 (refer to Product Information for timing of obinutuzumab and acalabrutinib doses) after which treatment must be monotherapy, ANDThe treatment must not be in combination with venetoclax.Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; orPatient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug, ANDMust be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18687	P18687	CN18687	Venetoclax	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapyPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses), ANDThe treatment must not be in combination with acalabrutinib, ANDThe treatment must cease upon disease progression.	Compliance with Authority Required procedures
C18688	P18688	CN18688	Blinatumomab	Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)Must be treated by a physician experienced in the treatment of haematological malignancies.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have achieved a complete remission, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition, ANDThe treatment must not be more than 2 treatment cycles under this restriction in a lifetime.For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.	Compliance with Authority Required procedures
C18691	P18691	CN18691	Upadacitinib	Severe active rheumatoid arthritisBalance of supply - first continuing treatmentMust be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment.	Compliance with Authority Required procedures
C18692	P18692	CN18692	Guselkumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 20 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18695	P18695	CN18695	Certolizumab pegol	Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; orPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application, ANDPatient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Written Authority Required procedures
C18696	P18696	CN18696	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 1 (new patient)Must be treated by a rheumatologist; orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; orPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; orPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) an active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Written Authority Required procedures
C18698	P18698	CN18698	Guselkumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 20 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18701	P18701	CN18701	Ixekizumab	Severe chronic plaque psoriasisContinuing treatment, Face, hand, footPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s), AND(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18704	P18704	CN18704	Tildrakizumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18705	P18705	CN18705	Tildrakizumab	Severe chronic plaque psoriasisBalance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; orPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18706	P18706	CN18706	Acalabrutinib	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)Continuing treatment (treatment cycles 3 to 14 inclusive) of first-line therapy - in combination with venetoclaxPatient must have previously received this drug as their most recent course of PBS-subsidised treatment for this condition, ANDThe treatment must not exceed 14 cycles in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first, ANDThe treatment must be in combination with venetoclax, ANDThe treatment must not be in combination with obinutuzumab.Must be treated by a medical practitioner. orMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18709	P18709	CN18709	Elranatamab	Relapsed or refractory multiple myelomaInduction treatment (step-up dosing)The condition must be confirmed by a histological diagnosis, ANDPatient must have progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; orPatient must be refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody, ANDPatient must have a WHO performance status of 2 or less, ANDPatient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.According to the TGA-approved Product Information, hospitalisation is recommended at minimum for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose.Patients who require restarting therapy due to dose delays may access step-up dosing through this induction treatment restriction.This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy.	Compliance with Authority Required procedures
C18713	P18713	CN18713	Guselkumab	Severe chronic plaque psoriasisInitial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle, ANDPatient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 20 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of prior biological treatment, including dosage, date and duration of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C18714	P18714	CN18714	Guselkumab	Severe chronic plaque psoriasisBalance of supply - Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 20 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 20 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 20 weeks treatment available under the above restrictions.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C18715	P18715	CN18715	Risankizumab	Severe chronic plaque psoriasisInitial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition, ANDThe condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.The most recent PASI assessment must be no more than 4 weeks old at the time of application.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.	Compliance with Written Authority Required procedures
C18717	P18717	CN18717	Tildrakizumab	Severe chronic plaque psoriasisInitial treatment - Initial 1, Face, hand, foot (new patient)Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis, ANDPatient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 28 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.The authority application must be made in writing and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition, AND(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.	Compliance with Written Authority Required procedures
C18721	P18721	CN18721	AdalimumabUstekinumab	Severe Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 18721
C18723	P18723	CN18723	Ustekinumab	Severe chronic plaque psoriasisFirst continuing treatment (Whole body)Must be treated by a dermatologist.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDThe treatment must be as systemic monotherapy; ORThe treatment must be in combination with methotrexate, ANDPatient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, ANDPatient must have demonstrated an adequate response to treatment, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The assessment of response to treatment must be provided in this application and documented in the patient's medical records.The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.	Compliance with Written Authority Required procedures
C18725	P18725	CN18725	Alectinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Initial treatmentPatient must not have previously received PBS-subsidised treatment with alectinib as adjuvant therapy in resected non-small cell lung cancer, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDThe condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC, ANDPatient must have a WHO performance status of 2 or less, ANDPatient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing.Must be treated by a medical practitioner.	Compliance with Authority Required procedures
C18726	P18726	CN18726	Alectinib	Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)Continuing treatmentThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this indication (i.e. for stage IIIB/IV NSCLC), ANDPatient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18736	P18736	CN18736	Romidepsin	Relapsed or chemotherapy refractory Peripheral T-cell LymphomaGrandfather arrangement - Transitioning from non-PBS-subsidised treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2026, ANDThe condition must be relapsed or chemotherapy refractory, ANDPatient must have undergone appropriate prior front-line curative intent chemotherapy prior to commencing non-PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed progressive disease while receiving treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C18765	P18765	CN18765	Upadacitinib	Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition, ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition, ANDPatient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; ORPatient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.Evidence of flared disease must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18767	P18767	CN18767	Adalimumab	Severe Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, or Continuing treatment), ANDThe treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; ORThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C18771	P18771	CN18771	Adalimumab	Severe Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.	Compliance with Authority Required procedures
C18777	P18777	CN18777	Infliximab	Severe Crohn diseaseBalance of supplyPatient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive), ANDThe treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.	Compliance with Authority Required procedures
C18785	P18785	CN18785	Ustekinumab	Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition, ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition, ANDPatient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; ORPatient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy, ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.Evidence of flared disease must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18795	P18795	CN18795	Adrenaline (epinephrine)	Acute allergic reaction with anaphylaxisInitial sole PBS-subsidised supply for anticipated emergency treatmentPatient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis.Patient must be aged 4 years or older.Patient must weigh 15 kg or more.	Compliance with Authority Required procedures
C18798	P18798	CN18798	Adrenaline (epinephrine)	Acute allergic reaction with anaphylaxisInitial sole PBS-subsidised supply for anticipated emergency treatmentPatient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; ORPatient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; ORPatient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; ORPatient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician.Patient must be aged 4 years or older.Patient must weigh 15 kg or more.The name of the specialist consulted must be provided at the time of application for initial supply.	Compliance with Authority Required procedures
C18800	P18800	CN18800	PralatrexateRomidepsin	Relapsed or chemotherapy refractory Peripheral T-cell LymphomaInitial treatmentThe condition must be relapsed or chemotherapy refractory, ANDPatient must have undergone appropriate prior front-line curative intent chemotherapy, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.	Compliance with Authority Required procedures
C18809	P18809	CN18809	Upadacitinib	Severe Crohn diseaseTransitioning from non-PBS-subsidised therapy that was commenced as a paediatric patientPatient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program), ANDPatient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition, ANDPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C18810	P18810	CN18810	Upadacitinib	Severe Crohn diseaseContinuing (maintenance) treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; ORThe condition must have not met the improvements specified above due to the prescribed dose being too low - this authority application seeks higher dosing.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.	Compliance with Authority Required procedures
C18811	P18811	CN18811	Upadacitinib	Severe Crohn diseaseContinuing (maintenance) treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.	Compliance with Authority Required procedures
C18813	P18813	CN18813	Adalimumab	Severe Crohn diseaseInitial 1 (new patient)Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, ANDPatient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; ORPatient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; ORPatient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ORPatient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy], AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria, AND(c) if applicable, details of intestinal inflammation marker/s, AND(d) if applicable, the CDAI score and the date of assessment, AND(e) the date of the most recent clinical assessment.Evidence of not achieving an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18814	P18814	CN18814	Adalimumab	Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response, ANDPatient must not receive more than 16 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment, AND(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline CDAI score and the date of assessment; and/or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18815	P18815	CN18815	Adalimumab	Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition, ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition, ANDPatient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; ORPatient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy, ANDPatient must not receive more than 16 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.Evidence of flared disease must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18817	P18817	CN18817	Upadacitinib	Severe Crohn diseaseInitial 1 (induction treatment covering the first 12 weeks in a patient untreated with targeted therapy)Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, ANDPatient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; ORPatient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; ORPatient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ORPatient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy], AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria, AND(c) if applicable, details of intestinal inflammation marker/s, AND(d) if applicable, the CDAI score and the date of assessment, AND(e) the date of the most recent clinical assessment.Evidence of not achieving an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18825	P18825	CN18825	Ustekinumab	Severe Crohn diseaseInitial 1 (new patient)Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, ANDPatient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; ORPatient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; ORPatient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ORPatient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below, ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy], AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria, AND(c) if applicable, details of intestinal inflammation marker/s, AND(d) if applicable, the CDAI score and the date of assessment, AND(e) the date of the most recent clinical assessment.Evidence of not achieving an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18826	P18826	CN18826	Ustekinumab	Severe Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment; and(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by applying through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.	Compliance with Authority Required procedures
C18827	P18827	CN18827	Ustekinumab	Severe Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment), ANDThe treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; ORThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C18828	P18828	CN18828	Futibatinib	Locally advanced or metastatic cholangiocarcinomaPatient must have evidence of a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement at treatment initiation, ANDPatient must have/have had received at least one line of systemic therapy prior to treatment initiation, ANDPatient must have/have had a World Health Organisation (WHO) performance status of no greater than 1 at treatment initiation with this drug, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 18828
C18829	P18829	CN18829	Pertuzumab	Early HER2 positive breast cancerContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be used in combination with trastuzumab, ANDThe treatment must have been initiated in combination with chemotherapy, ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure, ANDThe treatment must not extend beyond the following when initial and continuing therapy are combined: (i) 18 weeks (6 cycles) in the neoadjuvant setting; or (ii) 12 months (18 cycles) in total.	Compliance with Authority Required procedures
C18832	P18832	CN18832	PralatrexateRomidepsin	Relapsed or chemotherapy refractory Peripheral T-cell LymphomaContinuing treatmentThe condition must be relapsed or chemotherapy refractory, ANDPatient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.	Compliance with Authority Required procedures
C18840	P18840	CN18840	Midazolam	Generalized convulsive status epilepticusInitial treatmentPatient must have been assessed to be at significant risk of status epilepticus, ANDPatient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years.Patient must be at least six months of age.The treatment must be initiated by a specialist physician experienced in the treatment of epilepsy.	Compliance with Authority Required procedures
C18845	P18845	CN18845	Upadacitinib	Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment, AND(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline CDAI score and the date of assessment; and/or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 12 weeks of treatment with upadacitinib may be requested under the Balance of supply restriction.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18856	P18856	CN18856	Ustekinumab	Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response, ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment, AND(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline CDAI score and the date of assessment; and/or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18860	P18860	CN18860	Vedolizumab	Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment, AND(d) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline CDAI score and the date of assessment; and/or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18867	P18867	CN18867	Upadacitinib	Severe Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial or extended induction restriction (Initial 1, Initial 2, Initial 3, or Extended induction period (optional) treatment), ANDThe treatment must provide no more than the balance of up to 12 weeks therapy available under Initial 1, 2 or 3 treatment restriction or the Extended induction period (optional) from weeks 12 to 24 treatment restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C18869	P18869	CN18869	Infliximab	Severe Crohn diseaseContinuing treatmentPatient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; ORPatient must have both: (i) a total PCDAI score of 30 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; ORPatient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.	Compliance with Authority Required procedures - Streamlined Authority Code 18869
C18870	P18870	CN18870	Glycopyrronium	Severe primary axillary hyperhidrosisPatient must have previously failed topical aluminium chloride after one to two months of treatment; ORPatient must be intolerant to topical aluminium chloride treatment, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 18870
C18871	P18871	CN18871	Blinatumomab	Acute lymphoblastic leukaemiaInduction treatment of relapsed or refractory B-precursor cell ALLThe condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, ANDThe condition must not be present in the central nervous system or testis, ANDPatient must not have received more than 1 line of salvage therapy, ANDThe condition must be one of the following: (i) untreated with this drug for Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL), (ii) treated with this drug for Pre-B-cell ALL, but the condition has not relapsed within 6 months of completing that course of treatment, ANDThe condition must have more than 5% blasts in bone marrow; ORThe condition must have measurable residual disease based on measurement in bone marrow following complete remission, ANDThe treatment must not be more than 2 treatment cycles under this restriction in a lifetime.According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form, AND(3) date of most recent chemotherapy (if applicable), and if this was the initial chemotherapy regimen or salvage therapy;(4) for Philadelphia chromosome positive patients:(i) the date of the most recent treatment with a TKI (in combination with chemotherapy); OR(ii) if applicable the date of initial combined treatment with TKI and corticosteroids (if unable to tolerate chemotherapy).(5) if applicable, the date of completion of blinatumomab treatment for Pre-B-cell ALL in CR and the date of the patient's subsequent relapse, AND(6) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application.	Compliance with Written Authority Required procedures
C18877	P18877	CN18877	Vedolizumab	Severe Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial or continuing restriction (Initial 1, Initial 2, Initial 3, Continuing, or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment) with the subcutaneous form, ANDThe treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under either Initial 1, 2 or 3 treatment; ORThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C18878	P18878	CN18878	Vedolizumab	Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition, ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition, ANDPatient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 while off treatment with targeted therapy; ORPatient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; and evidence of flared disease while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and evidence of flared disease while off treatment with targeted therapy.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.Evidence of flared disease must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Authority Required procedures
C18879	P18879	CN18879	Vedolizumab	Severe Crohn diseaseTransitioning from non-PBS-subsidised therapy that was commenced as a paediatric patientPatient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program), ANDPatient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition, ANDPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend beyond 24 weeks.A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C18885	P18885	CN18885	Ustekinumab	Severe Crohn diseaseTransitioning from non-PBS-subsidised therapy that was commenced as a paediatric patientPatient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program), ANDPatient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition, ANDPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease. ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) if applicable, the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.	Compliance with Authority Required procedures
C18888	P18888	CN18888	Osimertinib	Non-small cell lung cancer (NSCLC)Patient must be each of: (i) initiating treatment with this drug; (ii) have not previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be continuing treatment with this drug for this condition, with an absence of further disease progression while being treated with this drug, ANDPatient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition, ANDPatient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.PBS-subsidised treatment with this drug is restricted to once per lifetime at any disease stage for NSCLC (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).Prescribers must refer to this drug's approved Therapeutic Goods Administration (TGA) Product Information (PI) for the relevant dosing regimens and treatment duration for the specific stage of NSCLC.For patients receiving treatment with this drug as adjuvant therapy, treatment must cease upon disease progression, or after the completion of three years from the first administered dose, whichever comes first.	Compliance with Authority Required procedures
C18896	P18896	CN18896	Upadacitinib	Severe Crohn diseaseExtended induction period (optional) from weeks 12 to 24Patient must must have experienced an inadequate therapeutic benefit following the initial 12-week induction period.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.	Compliance with Authority Required procedures
C18897	P18897	CN18897	Upadacitinib	Severe Crohn diseaseBalance of supplyPatient must have received insufficient therapy with this drug for this condition under the Continuing (maintenance) treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient restriction to complete 24 weeks of treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C18898	P18898	CN18898	Ustekinumab	Severe chronic plaque psoriasisFirst continuing treatment (Face, hand, foot)Must be treated by a dermatologist.Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDThe treatment must be as systemic monotherapy; ORThe treatment must be in combination with methotrexate, ANDPatient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, ANDPatient must have demonstrated an adequate response to treatment, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:(1) details of the proposed prescription(s), AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; OR(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The assessment of response to treatment must be provided in this application and documented in the patient's medical records.	Compliance with Written Authority Required procedures
C18899	P18899	CN18899	Pertuzumab	Early HER2 positive breast cancerInitial treatmentPatient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH), ANDPatient must have locally advanced, inflammatory or early stage, high risk (tumour greater than 2 cm in diameter or lymph node positive) breast cancer, ANDThe treatment must be used in combination with trastuzumab, ANDThe treatment must be initiated in combination with chemotherapy, ANDThe treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure, ANDPatient must not receive more than 1 treatment cycle under this restriction, ANDThe treatment must not extend beyond the following when initial and continuing therapy are combined: (i) 18 weeks (6 cycles) in the neoadjuvant setting; or (ii) 12 months (18 cycles) in total.Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification by in situ hybridisation (ISH) must be provided at the time of application.The pathology report must be documented in the patient's medical records.Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.	Compliance with Authority Required procedures
C18901	P18901	CN18901	Alectinib	Resected non-small cell lung cancer (NSCLC)Adjuvant therapyPatient must be both: (i) initiating treatment, (ii) untreated with an Anaplastic Lymphoma Kinase-Tyrosine Kinase Inhibitor (ALK-TKI) for non-small cell lung cancer; ORPatient must be continuing existing PBS-subsidised treatment with this drug; ORPatient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) untreated with ALK-TKI at the time this drug was initiated, ANDThe condition must be/have been at least one of: (i) node positive, (ii) at least 4 cm in size, ANDThe treatment must be for the purpose of adjuvant therapy following surgical resection, ANDThe treatment must be commenced within 26 weeks of surgery, ANDPatient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing, ANDPatient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 24 months of combined non-PBS and PBS-subsidised treatment for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred, ANDMust be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C18904	P18904	CN18904	Vedolizumab	Severe Crohn diseaseContinuing treatmentPatient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; ORPatient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; ORPatient must have demonstrated an adequate response to treatment with this drug (in any form).Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, current CDAI score and the date of assessment, AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, AND(c) the date of the most recent clinical assessment.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.At the time of the authority application, medical practitioners must request sufficient quantity for up to 24 weeks of treatment under this restriction.If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend the continuing treatment period.	Compliance with Authority Required procedures
C18907	P18907	CN18907	Botulinum toxin type A purified neurotoxin complex	Severe primary axillary hyperhidrosisPatient must have previously failed topical aluminium chloride after one to two months of treatment; ORPatient must be intolerant to topical aluminium chloride treatment.Patient must be aged 12 years or older.Must be treated by a dermatologist; ORMust be treated by a neurologist; ORMust be treated by a paediatrician.The treatment must be the sole PBS-subsidised therapy for this condition.Maximum number of treatments per year is 3, with no less than 4 months to elapse between treatments.	Compliance with Authority Required procedures - Streamlined Authority Code 18907
C18908	P18908	CN18908	Tenofovir with emtricitabine	Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infectionThe condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient, ANDPatient must have at least one of the following prior to having the latest PBS-subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.
C18909	P18909	CN18909	Vedolizumab	Severe Crohn diseaseInitial 1 (new patient)Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must not have achieved an adequate response to a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, ANDPatient must not have achieved an adequate response to prior treatment with a thiopurine at a clinically optimised dose for 3 or more consecutive months; ORPatient must not have achieved an adequate response to methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months, ANDPatient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of not achieving an adequate response to prior systemic therapy; ORPatient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below; ORPatient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of not achieving an adequate response to prior systemic therapy as specified below.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].Patient must be at least 18 years of age.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy], AND(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria, AND(c) if applicable, details of intestinal inflammation marker/s, AND(d) if applicable, the CDAI score and the date of assessment, AND(e) the date of the most recent clinical assessment.Evidence of not achieving an adequate response to prior therapy must include at least one of the following:(a) patient must have evidence of intestinal inflammation;(b) patient must be assessed clinically as being in a high faecal output state;(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.Evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; OR(ii) faeces: higher than normal lactoferrin or calprotectin level; OR(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18914	P18914	CN18914	Somatropin	Severe growth hormone deficiencyInitial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a childMust be treated by an endocrinologist.Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause, ANDPatient must have previously received non-PBS subsidised treatment with this drug for this condition as a child, ANDPatient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; ORPatient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; ORPatient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.Patient must have a mature skeleton.Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.The authority application must be made in writing and must include:1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name, AND2. A completed Severe Growth Hormone Deficiency supporting information form, AND3. Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.	Compliance with Written Authority Required procedures
C18917	P18917	CN18917	Somatropin	Severe growth hormone deficiencyInitial treatment of late onset growth hormone deficiencyMust be treated by an endocrinologist.Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; ORPatient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years, ANDPatient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; ORPatient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; ORPatient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre; ORPatient must have: (a) a chronological age of 18 years or older, (b) established hypothalamic-pituitary disease, (c) at least three documented pituitary hormone deficiencies, (d) an IGF-1 concentration lower than the sex- and age-specific lower limit of normal in a patient.The authority application must be made in writing and must include:1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name, AND2. A completed Severe Growth Hormone Deficiency supporting information form, AND3. If applicable, results of the growth hormone simulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.	Compliance with Written Authority Required procedures
C18920	P18920	CN18920	Somatropin	Severe growth hormone deficiencyInitial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a childMust be treated by an endocrinologist.Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause, ANDPatient must have previously received PBS-subsidised treatment with this drug for this condition as a child.Patient must have a mature skeleton.Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.The authority application must be made in writing and must include:1. Details of the proposed prescription, specifying the active ingredient name, form and strength of the medicine, followed by the brand name, AND2. A completed Severe Growth Hormone Deficiency supporting information form.	Compliance with Written Authority Required procedures
C18922	P18922	CN18922	Adrenaline (epinephrine)	Acute allergic reaction with anaphylaxisContinuing sole PBS-subsidised supply for anticipated emergency treatmentPatient must have previously been issued with an authority prescription for any form of this drug for this indication.	Compliance with Authority Required procedures
C18924	P18924	CN18924	Adrenaline (epinephrine)	Acute allergic reaction with anaphylaxisContinuing sole PBS-subsidised supply for anticipated emergency treatmentPatient must have previously been issued with an authority prescription for any form of this drug for this indication.Patient must be aged 4 years or older.Patient must weigh 15 kg or more.	Compliance with Authority Required procedures
C18926	P18926	CN18926	Abaloparatide	Severe established osteoporosisInitial treatment - Second-line therapyMust be treated by a consultant physician.Patient must not have received PBS-subsidised treatment with any of: (i) teriparatide, (ii) romosozumab or (iii) abaloparatide; ORPatient must have developed intolerance to (i) teriparatide, or (ii) romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy, ANDPatient must be at very high risk of fracture, ANDPatient must have a bone mineral density (BMD) T-score of -3.0 or less, ANDPatient must have had 2 or more fractures due to minimal trauma, ANDPatient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.	Compliance with Authority Required procedures
C18927	P18927	CN18927	Romosozumab	Severe established osteoporosisInitial treatment - Second-line therapyPatient must be at very high risk of fracture, ANDPatient must have a bone mineral density (BMD) T-score of -3.0 or less, ANDPatient must have had 2 or more fractures due to minimal trauma, ANDPatient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy, ANDPatient must not have received PBS-subsidised treatment with any of: (i) teriparatide, (ii) abaloparatide, or (iii) romosozumab; ORPatient must have developed intolerance to: (i) teriparatide, or (ii) abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.Must be treated by a consultant physician.A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.	Compliance with Authority Required procedures
C18931	P18931	CN18931	Tafasitamab	Relapsed or refractory follicular lymphomaInitial treatment (Cycles 1 - 5 inclusive)The treatment must be/have been initiated in combination with rituximab and lenalidomide, ANDThe condition must have relapsed or been refractory to at least one prior therapy prior to initiating treatment with this drug for this condition, ANDThe treatment must not exceed a total of 5 cycles of treatment under this restriction.The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.	Compliance with Authority Required procedures
C18938	P18938	CN18938	Tocilizumab	Severe active rheumatoid arthritisFirst continuing treatment - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.	Compliance with Authority Required procedures - Streamlined Authority Code 18938
C18939	P18939	CN18939	Tocilizumab	Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.	Compliance with Authority Required procedures - Streamlined Authority Code 18939
C18944	P18944	CN18944	Tocilizumab	Severe active juvenile idiopathic arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; OR(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; OR(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Written Authority Required procedures
C18945	P18945	CN18945	Tocilizumab	Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; OR(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; OR(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.	Compliance with Written Authority Required procedures
C18947	P18947	CN18947	Tocilizumab	Severe active juvenile idiopathic arthritisBalance of supply - Continuing treatmentPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.	Compliance with Authority Required procedures
C18948	P18948	CN18948	Tocilizumab	Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; ORPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to prior treatment must be documented in the patient's medical records.The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the active joint count, ESR and/or CRP result and date of results;(b) details of prior treatment, including dose and date/duration of treatment.(c) If applicable, details of any contraindications/intolerances.(d) If applicable, the maximum tolerated dose of methotrexate.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C18962	P18962	CN18962	Quinine	Malaria	Compliance with Authority Required procedures
C18966	P18966	CN18966	Adalimumab	Severe Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have a documented history of severe Crohn disease, ANDPatient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must not have previously received this drug for this condition in this treatment cycle; ORPatient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; ORPatient must have: (i) received this drug in this treatment cycle, (ii) not demonstrated/maintained an adequate response to this drug once in this treatment cycle, ANDPatient must not receive more than 16 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.Patient must be aged 6 to 17 years inclusive.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, the PCDAI score and the date of assessment; or(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' clinical and treatment criteria when targeted therapy treatment commenced. The following information must also be provided at the time of application:(a) the baseline PCDAI score and the date of assessment; or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18967	P18967	CN18967	Adalimumab	Severe Crohn diseaseInitial 3 (recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition, ANDPatient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised targeted therapy for this condition, ANDPatient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence, ANDPatient must have disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 while off treatment with targeted therapy; ORPatient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease while off treatment with targeted therapy, ANDPatient must not receive more than 16 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.Patient must be aged 6 to 17 years inclusive.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) current PCDAI score and the date of assessment; or(b) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or(ii) faeces: higher than normal lactoferrin or calprotectin level; or(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18968	P18968	CN18968	Adalimumab	Severe Crohn diseaseInitial 1 (new patient)Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence, ANDPatient must not have achieved an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy with a thiopurine at a clinically optimised dose, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; ORPatient must have a documented contraindication to each of prednisolone (or equivalent), a thiopurine, and methotrexate; ORPatient must have features of high-risk or complicated Crohn disease defined as those with any of the following: (i) perianal disease, (ii) stricturing or penetrating behaviour, (iii) severe delayed growth (growth velocity at least 2 standard deviations below the mean for age and sex, or a drop of at least 1 major centile band), ANDPatient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; ORPatient must have extensive intestinal inflammation of the small intestine as evidenced by radiological imaging, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.Patient must be aged 6 to 17 years inclusive.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) if applicable, details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and(b) current PCDAI score and the date of assessment; or(c) details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with extensive small intestine disease.For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or(ii) faeces: higher than normal lactoferrin or calprotectin level; or(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant contraindications or precautions in the TGA-approved Product Information, please provide details at the time of application. Patients must attempt to trial alternate conventional therapies that are not contraindicated.If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.Where a response assessment is not conducted, the patient will be deemed to have not responded to treatment with this drug. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.	Compliance with Authority Required procedures
C18972	P18972	CN18972	Romosozumab	Severe established osteoporosisInitial treatment - First-line therapyPatient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab, (iv) abaloparatide; ORPatient must have developed intolerance to abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy, ANDPatient must be at very high risk of fracture, ANDPatient must have a Bone Mineral Density (BMD) T-score of -2.5 or less, ANDPatient must have had a symptomatic fracture due to minimal trauma, ANDPatient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; ORPatient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy.Must be treated by a consultant physician.Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.	Compliance with Authority Required procedures
C18973	P18973	CN18973	Abaloparatide	Severe established osteoporosisInitial treatment - First-line therapyMust be treated by a consultant physician.Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab, or (iv) abaloparatide; ORPatient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy, ANDPatient must be at very high risk of fracture, ANDPatient must have a Bone Mineral Density (BMD) T-score of -2.5 or less, ANDPatient must have had a symptomatic fracture due to minimal trauma, ANDPatient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; ORPatient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.	Compliance with Authority Required procedures
C18976	P18976	CN18976	Tafasitamab	Relapsed or refractory follicular lymphomaContinuing treatment (Cycles 6 - 12 inclusive)The treatment must be in combination with lenalidomide, ANDPatient must have previously received treatment with this drug for this condition, ANDThe treatment must not exceed a total of 7 cycles of treatment under this restriction, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.The treatment must not exceed a total of 12 cycles in a lifetime for this indication measured from the initial dose, or must not extend beyond disease progression, whichever comes first.	Compliance with Authority Required procedures
C18987	P18987	CN18987	Infliximab	Severe Crohn diseaseInitial treatmentPatient must have received treatment with the PBS-subsidised IV formulation of this drug for this condition; ORPatient must have received an approved PBS authority prescription for treatment with the IV formulation of this drug for this condition; ORPatient must not have received treatment with the IV formulation of this drug, but has met the restrictions criteria as specified in the Initial 1, 2, or 3 for the IV formulation for this condition.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.The following information must be provided for patients who have not received the IV formulation as loading dose(s), but has met the restrictions criteria as specified in the Initial 1, 2, or 3 for the IV formulation:(i) reason for loading doses being omitted; and(ii) if applicable, details of prior systemic therapy [dosage, date of commencement and duration of therapy]; and(iii) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) nominated as the response criteria; and(iv) if applicable, details of intestinal inflammation marker/s; and(v) if applicable, the PCDAI or CDAI score and the date of assessment; and(vi) the date of the most recent clinical assessment.	Compliance with Authority Required procedures
C18989	P18989	CN18989	Adalimumab	Severe Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1, 2 or 3), ANDThe treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.	Compliance with Authority Required procedures
C18991	P18991	CN18991	Adalimumab	Severe Crohn diseaseContinuing treatmentPatient must have a documented history of severe Crohn disease, ANDPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have both: (i) a total PCDAI score of 40 points or less, and (ii) a reduction in PCDAI score by at least 15 points from baseline value; ORPatient must have an adequate response to this drug defined as an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist; ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]; ORMust be treated by a consultant physician [general medicine specialising in gastroenterology]; ORMust be treated by a paediatrician; ORMust be treated by a specialist paediatric gastroenterologist.Patient must be aged 6 to 17 years inclusive.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition under this treatment phase. Patients may re-trial treatment with this drug under the 'Initial 2' treatment phase if eligible. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.	Compliance with Authority Required procedures - Streamlined Authority Code 18991
C18997	P18997	CN18997	Abaloparatide	Severe established osteoporosisContinuing treatment - First-line therapyMust be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.	Compliance with Authority Required procedures
C18998	P18998	CN18998	Migalastat	Fabry diseaseGrandfather arrangement (transition from LSDP-funded Fabry disease therapy)Patient must have previously received treatment with this drug for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024; ORPatient must have previously received treatment with Enzyme Replacement Therapy for this condition funded under the Australian Government's Life Saving Drugs Program (LSDP) prior to 1 September 2024, ANDPatient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant prior to commencing treatment with this drug, ANDPatient must have/have had an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2 prior to commencing treatment with this drug, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a physician with expertise in the management of Fabry disease.Patient must be at least 12 years of age.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C18999	P18999	CN18999	Vorasidenib	Adult-type IDH-mutant astrocytoma or oligodendrogliomaGrandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2026, ANDPatient must have a World Health Organisation (WHO) Grade 2 astrocytoma or oligodendroglioma, ANDPatient must have had a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation at the time of initiation of non-PBS-subsidised treatment with this drug, ANDPatient must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, at initiation of non-PBS-subsidised treatment with this drug, ANDPatient must have had residual or recurrent disease after at least one prior surgery (biopsy, sub-total resection, or gross total resection) for this condition at the time of initiation of non-PBS-subsidised treatment with this drug for this condition, ANDThe condition must not have been previously treated with systemic anticancer therapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Confirm that evidence of the presence of a susceptible IDH1 or IDH2 variant in the tumour tissue is documented/retained in the patient's medical records once only with the first PBS prescription.	Compliance with Authority Required procedures - Streamlined Authority Code 18999
C19002	P19002	P19002	Tocilizumab	Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab.Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age.Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.	Compliance with Authority Required procedures
C19004	P19004	CN19004	Tocilizumab	Severe active rheumatoid arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C19006	P19006	CN19006	Tildrakizumab	Severe chronic plaque psoriasisContinuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supplyPatient must have received insufficient therapy with this drug under the continuing treatment (whole body) restriction to complete 24 weeks treatment; ORPatient must have received insufficient therapy with this drug under the continuing treatment (face/hand/foot) restriction to complete 24 weeks treatment, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.Must be treated by a dermatologist.	Compliance with Authority Required procedures
C19012	P19012	CN19012	Teriparatide	Severe established osteoporosisInitial treatmentMust be treated by a specialist; ORMust be treated by a consultant physician.Patient must be at very high risk of fracture, ANDPatient must have a bone mineral density (BMD) T-score of -3.0 or less, ANDPatient must have had 2 or more fractures due to minimal trauma, ANDPatient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDThe treatment must not exceed a lifetime maximum of 18 months therapy, ANDPatient must not have received PBS-subsidised treatment with any of: (i) romosozumab, (ii) abaloparatide; ORPatient must have developed intolerance to: (i) romosozumab, or (ii) abaloparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated.If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated.Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient's medical record.	Compliance with Authority Required procedures - Streamlined Authority Code 19012
C19016	P19016	CN19016	Vorasidenib	Adult-type IDH-mutant astrocytoma or oligodendrogliomaInitial treatmentPatient must have a World Health Organisation (WHO) Grade 2 astrocytoma or oligodendroglioma, ANDPatient must have a test of tumour tissue confirming the presence of a susceptible isocitrate dehydrogenase-1 (IDH1) variant or isocitrate dehydrogenase-2 (IDH2) variant, ANDPatient must have residual or recurrent disease after at least one prior surgery (biopsy, sub-total resection, or gross total resection) for this condition, ANDPatient must not be in immediate need of radiotherapy and/or chemotherapy for this condition, ANDThe condition must not have been previously treated with systemic anticancer therapy or radiotherapy, ANDPatient must have either a: (i) Karnofsky Performance Score of at least 80%, (ii) Lansky Performance Score of at least 80%.Confirm that evidence of the presence of a susceptible IDH1 or IDH2 variant in the tumour tissue is documented/retained in the patient's medical records once only with the first PBS prescription.	Compliance with Authority Required procedures - Streamlined Authority Code 19016
C19020	P19020	CN19020	Tocilizumab	Active giant cell arteritisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must not exceed 52 weeks in total including initial and continuing applications.Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.	Compliance with Authority Required procedures - Streamlined Authority Code 19020
C19021	P19021	CN19021	Selpercatinib	Advanced or metastatic medullary thyroid cancerThe condition must be unresectable with documented disease progression prior to commencing treatment with this drug, ANDThe condition must have evidence of activating RET variants in tumour material - this evidence has been obtained prior to commencing treatment with this drug, ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, ANDPatient must be initiating treatment with this drug; ORPatient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.	Compliance with Authority Required procedures - Streamlined Authority Code 19021
C19027	P19027	CN19027	Tocilizumab	Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records.An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.	Compliance with Authority Required procedures
C19028	P19028	CN19028	Tildrakizumab	Severe chronic plaque psoriasisContinuing treatment, Whole bodyPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have both: (i) experienced an adequate response following the most recent course of treatment at the 100 mg dosage regimen and (ii) the treating physician determined that a more satisfactory response can be achieved at the 200 mg dosage regimen; ORPatient must have demonstrated an adequate response to the most recent course of treatment with this drug at the 200 mg dosage regimen, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as:A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to not have responded to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient does not demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C19029	P19029	CN19029	Tildrakizumab	Severe chronic plaque psoriasisContinuing treatment, Face, hand, footPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have both: (i) experienced an adequate response following the most recent course of treatment at the 100 mg dosage regimen and (ii) the treating physician determined that a more satisfactory response can be achieved at the 200 mg dosage regimen; ORPatient must have demonstrated an adequate response to the most recent course of treatment with this drug at the 200 mg dosage regimen, ANDThe treatment must be as systemic monotherapy (other than methotrexate), ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a dermatologist.An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.The authority application must be made in writing and must include:(a) details of the proposed prescription(s); and(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The most recent PASI assessment must be no more than 4 weeks old at the time of application.Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to not have responded to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient does not demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.	Compliance with Written Authority Required procedures
C19034	P19034	CN19034	Migalastat	Fabry diseaseContinuing treatmentPatient must have received prior PBS-subsidised treatment with this drug for this condition, ANDPatient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record, ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by migalastat, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a physician with expertise in the management of Fabry disease.	Compliance with Authority Required procedures
C19035	P19035	CN19035	Vorasidenib	Adult-type IDH-mutant astrocytoma or oligodendrogliomaContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 19035
C19036	P19036	CN19036	Tocilizumab	Severe active rheumatoid arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the prescribing.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 19036
C19037	P19037	CN19037	Abaloparatide	Severe established osteoporosisContinuing treatment - Second-line therapyMust be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy, ANDThe treatment must not exceed a lifetime maximum of 18 months of PBS and non-PBS-subsidised therapy with this drug for this condition.	Compliance with Authority Required procedures
C19038	P19038	CN19038	Migalastat	Fabry diseaseInitial treatmentPatient must have at least one of: (i) documented deficiency of alpha-galactosidase enzyme activity in blood, (ii) presence of genetic mutations known to result in deficiency of alpha-galactosidase enzyme activity, ANDPatient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant, ANDPatient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2, ANDPatient must be male with Fabry-related renal disease confirmed by at least one of the following: (i) abnormal albuminuria of more than 20 mcg/min, as determined by 2 separate samples at least 24 hours apart, (ii) abnormal proteinuria of more than 150 mg/24 hours, (iii) albumin:creatinine ratio greater than upper limit of normal in 2 separate samples at least 24 hours apart, (iv) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; ORPatient must be female with Fabry-related renal disease confirmed by at least one of the following: (i) proteinuria of more than 300 mg/24 hours with clinical evidence of progression, (ii) renal disease due to long-term accumulation of glycosphingolipids in the kidneys; ORPatient must have Fabry-related cardiac disease confirmed by at least one of the following: (i) left ventricular hypertrophy, as evidenced by cardiac magnetic resonance imaging (MRI) or echocardiogram data, in the absence of hypertension, (ii) significant life-threatening arrhythmia or conduction defect, (iii) late gadolinium enhancement or a low T1 on cardiac MRI; ORPatient must have Fabry-related either: (i) ischaemic disease, (ii) cerebrovascular disease as shown on objective testing with no other cause or risk factors identified; ORPatient must have Fabry-related uncontrolled chronic pain despite the use of recommended doses of appropriate analgesia and antiseizure medications for peripheral neuropathy; ORPatient must have significant Fabry-related gastrointestinal symptoms despite the use of the recommended doses of appropriate pharmacological therapies, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a physician with expertise in the management of Fabry disease.Patient must be at least 12 years of age.If hypertension is present in patients relying their eligibility on Fabry-related cardiac disease, the prescriber must treat it optimally for at least 6 months prior to submitting the first PBS authority application.Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C19041	P19041	CN19041	Tocilizumab	Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; ORThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the active joint count, ESR and/or CRP result and date of result;(b) the most recent biological agent and the date of the last continuing prescription.(c) If applicable, the new baseline scores.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C19044	P19044	CN19044	Migalastat	Fabry diseaseSwitching from PBS-subsidised pegunigalsidase alfaPatient must have received prior treatment with PBS-subsidised pegunigalsidase alfa for this condition, ANDPatient must not have developed another life threatening/severe disease where long term prognosis is unlikely to be influenced by this drug, ANDPatient must have a documented migalastat amenable galactosidase alpha (GLA) gene variant, ANDPatient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must not have failed to demonstrate clinical improvement or stabilisation of this condition with previous PBS-subsidised treatment with this drug.Must be treated by a physician with expertise in the management of Fabry disease.Patient must be at least 12 years of age.Confirmation of eligibility for treatment with diagnostic reports including the confirmed mutations must be documented in the patient's medical records.	Compliance with Authority Required procedures
C19048	P19048	CN19048	Selpercatinib	Advanced or metastatic medullary thyroid cancerThe condition must be unresectable with documented disease progression prior to commencing treatment with this drug, ANDThe condition must have evidence of activating RET variants in tumour material - this evidence has been obtained prior to commencing treatment with this drug, ANDPatient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication, ANDPatient must be initiating treatment with this drug; ORPatient must be continuing treatment with this drug, with an absence of further disease progression while being treated with this drug.Medical practitioners must prescribe the appropriate quantities of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks per dispensing, according to the specified dosage in the approved Therapeutic Goods Administration (TGA) Product Information (PI). A separate authority prescription form must be completed for each strength requested.Medical practitioners may prescribe selpercatinib 80 mg with a quantity of up to 56 units where the dose does not exceed 120 mg twice daily (i.e., in combination with selpercatinib 40 mg). Selpercatinib 80 mg with a quantity of 112 units must be prescribed only where the dose is 160 mg twice daily to provide 28 days of treatment per dispensing. Prescribers should refer to the TGA PI for dosing and dose adjustments regimens.	Compliance with Authority Required procedures - Streamlined Authority Code 19048
C19052	P19052	CN19052	Epcoritamab	Relapsed or refractory diffuse large B-cell lymphoma (DLBCL)Induction treatmentThe condition must have relapsed, or be refractory to, at least two prior systemic therapies, ANDPatient must have a WHO performance status of no higher than 2, ANDPatient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; ORPatient must be currently unable to receive treatment with CAR-T cell therapy for this condition, ANDPatient must not be eligible for stem cell transplantation, ANDPatient must not have received prior treatment with a PBS-subsidised CD20xCD3 bispecific monoclonal antibody (unless this is for a re-priming cycle with epcoritamab due to missed or delayed dose), ANDThe treatment must be discontinued in patients who experience disease progression whilst on treatment.Prior systemic therapy may include autologous stem cell transplant.Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency.	Compliance with Authority Required procedures
C19059	P19059	CN19059	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerThe condition must have progressed on/following both: (i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; ORThe condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation, ANDPatient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug, ANDPatient must not have previously received PBS-subsidised treatment with this drug for this indication in any prior line of treatment, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing treatment with this drug for the first time. ORPatient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.	Compliance with Authority Required procedures - Streamlined Authority Code 19059
C19060	P19060	CN19060	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerGrandfather arrangement - Transitioning from non-PBS to PBS-subsided treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2026, ANDPatient must have/have had a WHO performance status score of no greater than 2 prior to initiation of non-PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing combination therapy consisting of no more than 24 months of: (i) enfortumab vedotin, (ii) pembrolizumab. ORPatient must be undergoing monotherapy with this drug after exceeding a lifetime total of 24 cumulative months of combination therapy consisting of: (i) enfortumab vedotin, (ii) pembrolizumab, from the first administered dose. ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to pembrolizumab, requiring temporary/permanent discontinuation; document the details in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 19060
C19061	P19061	CN19061	Enzalutamide	Hormone sensitive carcinoma of the prostateThe treatment must be for metastatic disease initiated within 6 months of treatment initiation with androgen deprivation therapy unless contraindicated to androgen deprivation therapy; ORThe treatment must be for non-metastatic disease where a baseline PSA doubling time (PSADT) of 9 months or less was observed, and the patient has undergone: (i) radical prostatectomy, (ii) radiation therapy, (iii) neither of the above as both therapies were contraindicated, ANDPatient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug, ANDPatient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (i.e. subsidy cannot occur across different treatment settings); ORPatient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation, ANDPatient must be undergoing concurrent androgen deprivation therapy unless contraindicated.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.The following applies to patients who are being treated for non-metastatic disease:(a) patients should cease treatment after 36 weeks if PSA is less than 0.2 ng/mL unless continued treatment is clinically indicated and the patient remains free of metastases;(b) patients who ceased treatment after meeting the suspension criteria (PSA less than 0.2 ng/mL after 36 weeks) should resume treatment if PSA levels increase to greater than or equal to 2.0 ng/mL for patients who had undergone radical prostatectomy, or greater than or equal to 5.0 ng/mL for those without prior prostatectomy, provided there is no evidence of metastatic disease.	Compliance with Authority Required procedures
C19091	P19091	CN19091	Dupilumab	Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ORPatient must have had a blood eosinophil count of at least 150 cells per microlitre no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ORPatient must have had a fractional exhaled nitric oxide of at least 20 ppb no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDPatient must be under the care of the same physician for at least 6 months; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine in this treatment cycle for either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.Patient must be aged 6 to less than 12 years.An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma or severe allergic asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made no more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An Asthma Control Questionnaire (ACQ-5) or Asthma Control Questionnaire interviewer administered version (ACQ-5-IA) assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be submitted no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine.A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) the IgE, blood eosinophil or fractional exhaled nitric oxide result and date; and(b) Asthma Control Questionnaire (ACQ-5) score; or(c) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.(d) the details of prior biological medicine treatment including the details of date and duration of treatment; and(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
C19098	P19098	CN19098	Ruxolitinib	Grade II to IV acute graft versus host disease (aGVHD)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.Must be treated by a specialist medical practitioner. ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist medical practitioner.Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.The assessment of response must be documented in the patient's medical records.Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 19098
C19100	P19100	CN19100	Ruxolitinib	Polycythemia veraBalance of Initial treatment - up to 48 weeksPatient must have received this drug as their most recent course of PBS-subsidised treatment for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be at least 18 years of age.Must be treated by a medical practitioner.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.	Compliance with Authority Required procedures
C19103	P19103	CN19103	Ruxolitinib	Polycythemia veraInitial treatmentPatient must be resistant to hydroxycarbamide (hydroxyurea); ORPatient must have an intolerance to hydroxycarbamide (hydroxyurea) of a severity necessitating permanent treatment withdrawal; ORPatient must have developed a clinically important adverse event/contraindication to hydroxycarbamide (hydroxyurea) as defined in the TGA-approved Product Information necessitating permanent treatment withdrawal, ANDPatient must not have previously received PBS-subsidised treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner.Hydroxycarbamide (hydroxyurea) resistance is defined as a minimum of 12 consecutive weeks treatment at a dose of at least 1.5 grams/day or at the maximum tolerated that still results in one of the following:(i) the need to reduce haematocrit levels to below 45% through phlebotomy; OR(ii) a platelet count greater than 400 x 109/L and a white blood cell count greater than 10 x 109/LIf applicable, details of prior systemic treatment with hydroxycarbamide (hydroxyurea) that caused either (i) an intolerance, (ii) an adverse event as listed in the TGA-approved Product Information, or (iii) a contraindication as listed in the TGA-approved Product Information necessitating permanent treatment withdrawal should be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C19104	P19104	CN19104	Ruxolitinib	Polycythemia veraSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have achieved and maintained a response to treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures
C19106	P19106	CN19106	Adalimumab	Complex refractory Fistulising Crohn diseaseInitial 1 (new patient or recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must have an externally draining enterocutaneous or rectovaginal fistula, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].The number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition must be provided by the prescriber at the time of application and documented in the patient's medical records.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
C19110	P19110	CN19110	Infliximab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug (in any form) as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Patient must be at least 18 years of age.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/OR(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.	Compliance with Authority Required procedures - Streamlined Authority Code 19110
C19115	P19115	CN19115	Adalimumab	Complex refractory Fistulising Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response, ANDPatient must not receive more than 16 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) current number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition; AND(b) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The application must also provide details of the baseline scores of the prior eligibility requirements, including the number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.	Compliance with Authority Required procedures
C19132	P19132	CN19132	Dupilumab	Uncontrolled severe asthmaInitial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; ORPatient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; ORPatient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; ANDPatient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; ORPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.Optimised asthma therapy includes:(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;AND(ii) treatment with oral corticosteroids as outlined in the clinical criteria.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(d) Asthma Control Questionnaire (ACQ-5) score; and(e) if applicable, the eosinophil count and date; and(f) if applicable, the IgE result and date.	Compliance with Written Authority Required procedures
C19133	P19133	CN19133	Dupilumab	Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; ANDPatient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; ORPatient must have each of: (i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, (ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; ANDPatient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and(c) if applicable, the eosinophil count and date; and(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and(e) if applicable, the IgE result and date; and(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
C19136	P19136	CN19136	Dupilumab	Uncontrolled severe asthmaContinuing treatmentMust be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; ANDPatient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease; ANDPatient must not receive more than 24 weeks of treatment under this restriction.Patient must be aged 12 years or older.An adequate response to this biological medicine is defined as:(a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline,OR(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5.All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and, for the application for continuing therapy to be processed.The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment.A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following information must be provided at the time of application and must be documented in the patient's medical records:(a) if applicable, details of maintenance oral corticosteroid dose; and(b) a completed Asthma Control Questionnaire (ACQ-5) score.	Compliance with Written Authority Required procedures
C19137	P19137	CN19137	Dupilumab	Uncontrolled severe asthmaInitial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy)Patient must not have received PBS-subsidised treatment with a biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ORPatient must have had a break in treatment from the most recently approved PBS-subsidised biological medicine for either: (i) severe asthma, (ii) severe allergic asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have total serum human immunoglobulin E of at least 30 IU/mL with past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the last 12 months; ORPatient must have blood eosinophil count of at least 150 cells per microlitre in the last 12 months; ORPatient must have a fractional exhaled nitric oxide of at least 20 ppb in the last 12 months; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDPatient must be under the care of the same physician for at least 6 months; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.Patient must be aged 6 to less than 12 years.Optimised asthma therapy includes:(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;AND(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The initial IgE assessment, blood eosinophil count or fractional exhaled nitric oxide measurement must be no more than 12 months old at the time of application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),AND(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 28 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the last dose of biological medicine, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with this biological medicine for this condition.A patient who fails to demonstrate a response to treatment with this biological medicine will not be eligible to receive further PBS-subsidised treatment with this biological medicine for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 2 biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of dupilumab of up to 32 weeks.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and(b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(c) the IgE, blood eosinophil or the fractional exhaled nitric oxide result and date; and(d) Asthma Control Questionnaire (ACQ-5) score; or(e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.	Compliance with Written Authority Required procedures
C19146	P19146	CN19146	Ruxolitinib	Polycythemia veraFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised treatment for this condition, ANDPatient must have achieved and maintained a response to treatment with this drug for this condition.Patient must be at least 18 years of age.Must be treated by a medical practitioner.A response to treatment is defined as:(i) Maintaining a haematocrit level of less than 45% without relying on phlebotomy and which was measured at least 12 weeks after the most recent phlebotomy procedure (if performed to reduce red blood cell levels); OR(ii) Ability to demonstrate or maintain a normal platelet count of less than or equal to 400 x 109/L; OR(iii) The absence of palpable splenomegaly.The following must be documented in the patient's medical records:(a) details (dates, unique identifying number/code, or provider number) of the pathology report confirming the patient has achieved and maintained a response within 48 weeks of treatment initiation; OR(b) confirmation that the patient does not have palpable splenomegaly.	Compliance with Authority Required procedures
C19147	P19147	CN19147	Ruxolitinib	Grade II to IV acute graft versus host disease (aGVHD)Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.Must be treated by a specialist medical practitioner. ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist medical practitioner.Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD.(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD.The assessment of response must be documented in the patient's medical records.Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 19147
C19149	P19149	CN19149	AdalimumabUstekinumab	Complex refractory Fistulising Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under any relevant initial restriction (Initial 1 or Initial 2), ANDThe treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C19157	P19157	CN19157	Adalimumab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].The current number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition must be provided by the prescriber at the time of application and documented in the patient's medical records.An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/OR(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
C19158	P19158	CN19158	Adalimumab	Complex refractory Fistulising Crohn diseaseBalance of supplyPatient must have received insufficient treatment with this drug for this condition under the Continuing treatment restriction, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C19159	P19159	CN19159	Durvalumab	Resected gastric and gastroesophageal junction adenocarcinomaAdjuvant treatmentPatient must have previously received PBS-subsidised neoadjuvant treatment with this drug for this condition; ORPatient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) treated with combined therapy with durvalumab and FLOT as neoadjuvant treatment for this condition, ANDThe treatment must be for the purposes of adjuvant use following surgical resection, ANDThe treatment must be/have been initiated in combination with adjuvant FLOT for up to 2 cycles unless intolerant to FLOT requiring permanent discontinuation, ANDThe treatment must be sole PBS-subsidised systemic anti-cancer therapy from cycles 3-12 of adjuvant treatment, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 12 cycles of adjuvant treatment for this condition from the first administered dose following surgery, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Where 'FLOT' is referenced in this restriction, it refers to the combination therapy of fluorouracil (5-FU) in combination with leucovorin (folinic acid), oxaliplatin and docetaxel.	Compliance with Authority Required procedures
C19168	P19168	CN19168	Obinutuzumab	Lupus nephritisInitial treatmentPatient must have a confirmed diagnosis of active class III or IV lupus nephritis with or without class V disease, confirmed by renal biopsy, ANDPatient must not have severe renal impairment, demonstrated by an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2, ANDPatient must have/have had a urinary protein-to-creatinine ratio (UPCR) of at least 113 mg/mmol (equivalent to 1g/g) prior to initiation of treatment with this drug, ANDThe treatment must be administered with mycophenolate and corticosteroids unless contraindicated/intolerant necessitating treatment withdrawal, ANDThe treatment must not be used in combination with anifrolumab.Must be treated by a specialist physician experienced in the management of this condition.The baseline values of the eGFR and UCPR must be documented in the patient's medical records, as it will inform the basis for determining if worsening of the condition has occurred.	Compliance with Authority Required procedures
C19169	P19169	CN19169	Obinutuzumab	Lupus nephritisFirst continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction, ANDPatient must not have sustained clinically significant, worsening from baseline values of either: (i) urinary protein-to-creatinine ratio (UPCR); and/or (ii) estimated glomerular filtration rate (eGFR), as determined by the treating physician, ANDThe treatment must be administered with mycophenolate and corticosteroids unless contraindicated/intolerant necessitating treatment withdrawal, ANDThe treatment must not be used in combination with anifrolumab.Must be treated by a specialist physician experienced in the management of this condition.The current values for UPCR and eGFR, used to determine the patient's response to treatment, must be documented in the patient's medical records.	Compliance with Authority Required procedures
C19171	P19171	CN19171	Ustekinumab	Complex refractory Fistulising Crohn diseaseInitial 1 (new patient or recommencement of treatment after a break in targeted therapy of more than 12 months)Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician, ANDPatient must have an externally draining enterocutaneous or rectovaginal fistula, ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].The number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition must be provided by the prescriber at the time of application and documented in the patient's medical records.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
C19172	P19172	CN19172	Ustekinumab	Complex refractory Fistulising Crohn diseaseInitial 2 (change or recommencement of treatment after a break in targeted therapy of less than 12 months)Patient must have received prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle; ORPatient must have been eligible for prior PBS-subsidised treatment with a targeted therapy for this condition in this treatment cycle, ANDPatient must have either: (i) not previously received this drug for this condition in the current treatment cycle, (ii) previously received this drug and demonstrated/maintained an adequate clinical response, ANDThe treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) current number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition; AND(b) details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.If a patient was eligible for prior PBS-subsidised treatment with a targeted therapy for this condition but did not receive PBS-subsidised treatment at the time, the application must provide a declaration that the patient met all 'Initial 1' eligibility requirements when targeted therapy treatment commenced. The application must also provide details of the baseline scores of the prior eligibility requirements, including the number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment.Where fewer than 2 doses are requested at the time of the application, authority approvals for sufficient treatment based on the patient's weight to complete dosing at weeks 0 and 8 may be requested through the Balance of supply restriction.Under no circumstances will approvals be granted for treatment that would otherwise extend the initial treatment period.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
C19174	P19174	CN19174	AdalimumabUstekinumab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/OR(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.If a patient does not demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 19174
C19178	P19178	CN19178	Infliximab	Complex refractory Fistulising Crohn diseaseBalance of supplyPatient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive), ANDThe treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment.Patient must be at least 18 years of age.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].	Compliance with Authority Required procedures
C19181	P19181	CN19181	Dupilumab	Uncontrolled severe asthmaInitial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; ORPatient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; ANDPatient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; ORPatient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; ANDPatient must have a duration of asthma of at least 1 year; ANDPatient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; ORPatient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; ORPatient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; ANDPatient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.Optimised asthma therapy includes adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated.If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application:(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND(b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle.A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with all eligible biological medicines within the same treatment cycle.The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and(b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and(c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and(d) Asthma Control Questionnaire (ACQ-5) score; and(e) if applicable, the eosinophil count and date; and(f) if applicable, the IgE result and date.	Compliance with Written Authority Required procedures
C19188	P19188	CN19188	Obinutuzumab	Lupus nephritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must not have demonstrated evidence of clinically significant worsening of the condition, confirmed by either: (i) an increase in urinary protein-to-creatinine ratio (UPCR); or (ii) a reduction in estimated glomerular filtration rate (eGFR) from baseline values, due to persisting active class III or IV lupus nephritis, based on 2 measurements taken 3 months apart, ANDThe treatment must be administered with mycophenolate and corticosteroids unless contraindicated/intolerant necessitating treatment withdrawal, ANDThe treatment must not be used in combination with anifrolumab.Must be treated by a specialist physician experienced in the management of this condition.The values for UPCR and eGFR, taken 3 months apart, used to determine the patient's response to treatment, must be documented in the patient's medical records.	Compliance with Authority Required procedures
C19191	P19191	CN19191	Ruxolitinib	Moderate to severe chronic graft versus host disease (cGVHD)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must have responding disease at 24 weeks compared with baseline, demonstrated by either a: (i) partial response, (ii) complete response, ANDThe treatment must be the sole PBS-subsidised treatment for this condition with the exception of: (i) corticosteroids, (ii) calcineurin inhibitors.Must be treated by a specialist medical practitioner. ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) who is both: (i) continuing existing therapy with this medicine (i.e. not initiating treatment), (ii) has agreement from the treating specialist medical practitioner.Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib.(a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy.(b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies.The assessment of response must be documented in the patient's medical records.Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures - Streamlined Authority Code 19191
C19192	P19192	CN19192	Pembrolizumab	Immunotherapy sensitive advanced or metastatic cancerPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions. ORPatient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 19192
C19193	P19193	CN19193	Ustekinumab	Complex refractory Fistulising Crohn diseaseContinuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].The current number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition must be provided by the prescriber at the time of application and documented in the patient's medical records.An adequate response is defined as:(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/OR(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 1 treatment restriction.	Compliance with Authority Required procedures
C19195	P19195	CN19195	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerPatient must not have received prior systemic therapy for this condition at the initiation of treatment with this drug, with the exception of neoadjuvant/adjuvant chemotherapy, ANDPatient must have/have had a WHO performance status score of no greater than 2 at treatment initiation with this drug.Patient must be undergoing combination therapy consisting of no more than 24 months of: (i) enfortumab vedotin, (ii) pembrolizumab; ORPatient must be undergoing monotherapy with this drug after exceeding a lifetime total of 24 cumulative months of combination therapy consisting of: (i) enfortumab vedotin, (ii) pembrolizumab, from the first administered dose; ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to pembrolizumab, requiring temporary/permanent discontinuation; document the details in the patient's medical records, ANDPatient must be undergoing treatment with this drug for the first time. ORPatient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.	Compliance with Authority Required procedures - Streamlined Authority Code 19195
C19209	P19209	CN19209	Infliximab	Complex refractory Fistulising Crohn diseaseInitial treatmentPatient must have received treatment with the PBS-subsidised IV formulation of this drug for this condition; ORPatient must have received an approved PBS authority prescription for treatment with the IV formulation of this drug for this condition; ORPatient must not have received treatment with the IV formulation of this drug, but has met the restrictions criteria as specified in the Initial 1 or 2 for the IV formulation for this condition.Patient must be at least 18 years of age.Must be treated by a gastroenterologist. ORMust be treated by a consultant physician [internal medicine specialising in gastroenterology]. ORMust be treated by a consultant physician [general medicine specialising in gastroenterology].The following information must be provided for patients who have not received the IV formulation as loading dose(s), but has met the restrictions criteria as specified in the Initial 1 or 2 for the IV formulation:(i) reason for loading doses being omitted; AND(ii) if applicable, baseline number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition; AND(iii) if applicable, current number of externally draining complex fistulae, fistula symptom grading scores (discharge/pain/induration) and the date of assessment of the patient's condition; AND(iv) if applicable, details of the most recent targeted therapy in the current treatment cycle, including the date and duration of treatment.	Compliance with Authority Required procedures
C19213	P19213	CN19213	Dupilumab	Uncontrolled severe asthmaInitial treatment - Initial 2 (Change of treatment)Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.Patient must be under the care of the same physician for at least 6 months; ORPatient must have been diagnosed by a multidisciplinary severe asthma clinic team; ANDPatient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; ANDPatient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; ANDPatient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; ORPatient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; ORPatient must have had a total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; ANDPatient must not receive more than 32 weeks of treatment under this restriction; ANDThe treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for any of: (i) nasal polyps; (ii) uncontrolled severe allergic asthma; (iii) uncontrolled severe asthma; (iv) uncontrolled chronic obstructive pulmonary disease.Patient must be aged 12 years or older.An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine.At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter.A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts.A multidisciplinary severe asthma clinic team comprises of:(i) A respiratory physician; and(ii) A pharmacist, nurse or asthma educator.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).The following must be provided at the time of application and documented in the patient's medical records:(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and(b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and(c) if applicable, the eosinophil count and date; and(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and(e) if applicable, the IgE result and date; and(f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).	Compliance with Written Authority Required procedures
C19218	P19218	CN19218	Asciminib	Chronic Myeloid Leukaemia (CML)Continuing Treatment for patients with T315I mutationPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records.The continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; OR(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription; AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy	Compliance with Written Authority Required procedures
C19222	P19222	CN19222	Durvalumab	Resectable gastric and gastroesophageal junction adenocarcinomaNeoadjuvant treatmentPatient must be initiating treatment with this drug for this condition; ORPatient must be transitioning from existing non-PBS to PBS-subsidised supply of this drug, ANDThe condition must be Stage II or higher, ANDThe condition must be resectable, ANDThe treatment must be for the purpose of neoadjuvant use in a patient preparing for surgery, ANDPatient must have a WHO performance status no greater than 1, ANDThe treatment must be initiated in combination with neoadjuvant FLOT, ANDThe condition must have been untreated with systemic therapy.Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 2 cycles of neoadjuvant treatment from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression/recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Where 'FLOT' is referenced in this restriction, it refers to the combination therapy of fluorouracil (5-FU) in combination with leucovorin (folinic acid), oxaliplatin and docetaxel.	Compliance with Authority Required procedures
C19223	P19223	CN19223	DasatinibImatinibNilotinib	Chronic Myeloid Leukaemia (CML)Initial treatmentPatient must have a primary diagnosis of chronic myeloid leukaemia, ANDPatient must not have previously experienced an inadequate response to PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.	Compliance with Authority Required procedures
C19225	P19225	CN19225	DasatinibImatinibNilotinib	Chronic Myeloid Leukaemia (CML)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be responding to treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19225
C19226	P19226	CN19226	Ponatinib	Chronic Myeloid Leukaemia (CML)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; ORPatient must have demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C19231	P19231	CN19231	Tofersen	Amyotrophic lateral sclerosisInitial treatmentPatient must have/have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing treatment with this drug, ANDThe condition must have been diagnosed by a neurologist, ANDThe condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.The following must be documented in the patient's medical records:a) date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant, ANDb) baseline score of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) at treatment initiation.	Compliance with Authority Required procedures
C19234	P19234	CN19234	Asciminib	Chronic Myeloid Leukaemia (CML)Continuing treatment for patients without T315I mutationPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a response at 12-monthly intervals of either: (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19234
C19236	P19236	CN19236	Dupilumab	Uncontrolled severe asthmaInitial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment - Balance of Supply in a patient aged 6 to 12 yearsPatient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 32 weeks of treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 32 weeks of treatment; ORPatient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment, ANDThe treatment must provide no more than the balance of up to 32 weeks treatment available under the Initial 1 and Initial 2 restriction; ORThe treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing restriction.Must be treated by a medical practitioner who is either a:(i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.	Compliance with Authority Required procedures
C19237	P19237	CN19237	Tofersen	Amyotrophic lateral sclerosisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the first continuing treatment, the extended first continuing treatment or the grandfather treatment restriction, ANDPatient must have demonstrated an adequate response to treatment defined as any improvement or stabilisation in the ALSFRS-R score (i.e. no more than a 20% decline from the baseline ALSFRS-R score), if they have received treatment under the first continuing or extended first continuing restriction; ORPatient must have demonstrated a clinical benefit from treatment, based on clinician judgment, within 12 months of treatment initiation, if they have received treatment under the grandfather listing, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.	Compliance with Authority Required procedures
C19243	P19243	CN19243	Tofersen	Amyotrophic lateral sclerosisFirst continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.Assessment of response must be conducted after 6 months of the first continuing treatment (i.e. at 12 months from treatment initiation).If a response to treatment cannot be demonstrated at this assessment, prescribers may apply for up to a maximum of three months (i.e. 2 repeats) of additional continuing treatment under the extended first continuing treatment phase to verify non-response.Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.All the assessments of response must be documented in the patient's medical records.Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R.	Compliance with Authority Required procedures
C19246	P19246	CN19246	Ponatinib	Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients with T315I mutationPatient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale, AND(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Up to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures
C19250	P19250	CN19250	Sunitinib	Metastatic or unresectable malignant gastrointestinal stromal tumourInitial treatmentThe condition must not be resectable, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDPatient must have a WHO performance status of 2 or less, ANDPatient must have previously failed or be intolerant to imatinib mesilate.Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription, AND(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib.	Compliance with Written Authority Required procedures
C19252	P19252	CN19252	Edaravone	Amyotrophic lateral sclerosisInitial treatmentThe condition must be/have been diagnosed by a neurologist, ANDPatient must not have had symptoms for more than 2 years prior to commencing therapy with this drug, ANDPatient must have at least 80 percent of predicted forced vital capacity (FVC) or slow vital capacity (SVC) within the 2 months prior to commencing therapy with this drug, ANDPatient must not require assistance with eating or ambulation prior to commencing treatment with this drug, ANDPatient must have at least two points on each individual item of the ALS Functional Rating Scale - Revised (ALSFRS-R) score prior to commencing therapy with this drug, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving concomitant treatment with tofersen for this condition.The date of diagnosis, the date and results of spirometry (in terms of percent of predicted forced vital capacity or slow vital capacity) must be supplied with the initial authority application.Prescribers must request a quantity sufficient to cover one month per dispensing, in accordance with the patient's treatment cycle. Prescribers must request a smaller number of units than the listed maximum quantity units if it is adequate for the patient's needs.	Compliance with Authority Required procedures
C19253	P19253	CN19253	Tofersen	Amyotrophic lateral sclerosisGrandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatmentPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2026, ANDPatient must have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing non-PBS-subsidised treatment with this drug, ANDThe condition must have been diagnosed by a neurologist, ANDThe condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.The date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant must be documented in the patient's medical records.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria.	Compliance with Authority Required procedures
C19255	P19255	CN19255	Ponatinib	Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients without T315I mutationPatient must have experienced an inadequate response to an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal, ANDPatient must have experienced an inadequate response to an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale, AND(iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.All reports must be documented in the patient's medical recordsIf the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Up to a maximum of 18 months of treatment may be authorised under this initial restriction.	Compliance with Written Authority Required procedures
C19259	P19259	CN19259	Tacrolimus	Moderate to severe atopic dermatitisFlare treatmentPatient must have 1 or more of the following contraindications to topical corticosteroids: (i) perioral dermatitis; (ii) periorbital dermatitis; (iii) rosacea; (iv) epidermal atrophy; (v) dermal atrophy; (vi) allergy to topical corticosteroids; (vii) cataracts; (viii) glaucoma; (ix) raised intraocular pressure. ORThe condition must not have been adequately controlled with topical corticosteroid therapy.Inadequate control of this condition with topical corticosteroid therapy is defined as:(i) no clearance of the skin despite at least 2 weeks of a potent topical corticosteroid for the body or a mild topical corticosteroid for the face and eyelids, applied every day; OR(ii) clearing of the skin with at least 2 weeks of a potent topical corticosteroid for the body or a mild topical corticosteroid for the face and eyelids, applied every day, but almost immediate and significant flare in disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions.Treatment should be discontinued, and further treatment options should be considered if no signs of improvement are seen after 2 weeks of treatment.Once clearance or near clearance of atopic dermatitis is achieved, patients should cease tacrolimus treatment and reinitiate only if there is a flare of their atopic dermatitis that meets the PBS eligibility criteria.	Compliance with Authority Required procedures
C19260	P19260	CN19260	Asciminib	Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients without T315I mutationThe condition must not be in the blast phase, ANDPatient must have experienced an inadequate response to an adequate trial of at least two tyrosine kinase inhibitors; ORPatient must have experienced intolerance, not an inadequate response, to at least two tyrosine kinase inhibitors; ORPatient must have experienced an inadequate response to an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Blast phase defined according to the latest WHO criteria.A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.	Compliance with Authority Required procedures
C19261	P19261	CN19261	Tofersen	Amyotrophic lateral sclerosisExtended first continuing treatment (additional 3 doses)Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must not have demonstrated an adequate response to treatment with this drug for this condition, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.All the assessments of response must be documented in the patient's medical records.Patient may qualify for this treatment phase once only.Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R.	Compliance with Authority Required procedures
C19267	P19267	CN19267	Edaravone	Amyotrophic lateral sclerosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving concomitant treatment with tofersen for this condition.	Compliance with Authority Required procedures
C19268	P19268	CN19268	Tocilizumab	Active giant cell arteritisInitial treatmentMust be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause, ANDPatient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; ORPatient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; ORPatient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging, ANDPatient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis, ANDPatient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; ORPatient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; ORPatient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis, ANDThe treatment must be in combination with a tapering course of corticosteroids, ANDThe treatment must not exceed 52 weeks in total including initial and continuing applications.Patient must be aged 50 years or older.Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging, AND(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures
C19277	P19277	CN19277	Asciminib	Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients with T315I mutationThe condition must not be in the blast phase, ANDPatient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report, ANDThe condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; ORThe condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR), ANDPatient must have experienced an inadequate response to an adequate trial of at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have experienced intolerance, not an inadequate response, to at least one tyrosine kinase inhibitor, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale, AND(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation, AND(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapyUp to a maximum of 18 months of treatment may be authorised under this initial restriction.Blast phase defined according to the latest WHO criteria.A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.	Compliance with Written Authority Required procedures
C19280	P19280	CN19280	Ribociclib	Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine, ANDPatient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C19282	P19282	CN19282	Abemaciclib	Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib.Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit, ANDMust be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures
C19283	P19283	CN19283	Ribociclib	Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab, ANDPatient must require dosage reduction requiring a pack of 21 tablets.Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit, ANDMust be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).	Compliance with Authority Required procedures

Part 2 · Variation rules

2Variation rules#

The following table sets out variation rules for variations codes, for the purposes of sections 15 and 16.

Variation Code	Listed Drug	Variation Rules
V4118	GranisetronOndansetron	Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
V4139	Granisetron	Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
V5618	Ondansetron	Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
V5721	Ondansetron	Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
V5743	Ondansetron	Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
V5778	Ondansetron	Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle.
V7273	Icatibant	Increased maximum quantities will be limited to 12 injections per authority prescription.
V7274	Icatibant	Increased maximum quantities will be limited to 12 injections per authority prescription.
V7433	Axitinib	Prescribers may request an increased maximum quantity sufficient to provide up to one month's supply for patients who require dose adjustment.
V8588	Axitinib	Prescribers may request an increased maximum quantity sufficient to provide up to one month's supply for patients who require dose adjustment.
V9919	Sodium phenylbutyrate	An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m²/day in patients weighing more than 20 kg.
V9993	Sodium phenylbutyrate	An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m²/day in patients weighing more than 20 kg.
V10748	BuprenorphineMorphineOxycodoneOxycodone with naloxoneTapentadolTramadol	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10752	BuprenorphineMorphineOxycodoneOxycodone with naloxoneTapentadolTramadol	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment(i) is less than 12 months; or(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10755	BuprenorphineMorphineOxycodoneOxycodone with naloxoneTapentadolTramadol	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10756	Morphine	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10762	Morphine	Authorities for increased maximum quantities and/or repeats must only be considered for(i) severe disabling pain associated with proven malignant neoplasia; or(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10764	CodeineCodeine with paracetamolHydromorphoneMorphineOxycodoneTramadol	Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for(i) severe disabling pain associated with malignant neoplasia; or(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months; or(iii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(v) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10765	Morphine	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10770	HydromorphoneMorphine	Authorities for increased maximum quantities and/or repeats must only be considered for(i) severe disabling pain associated with proven malignant neoplasia; or(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10771	CodeineCodeine with paracetamolOxycodoneTramadol	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10772	CodeineCodeine with paracetamolOxycodoneTramadol	Authorities for increased maximum quantities and/or repeats must only be considered for(i) severe disabling pain associated with proven malignant neoplasia; or(ii) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iv) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10775	Morphine	Authorities for increased maximum quantities and/or repeats must only be considered for(i) palliative care patients with chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or(ii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iii) chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10777	HydromorphoneMorphine	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10814	Morphine	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment(i) is less than 12 months; or(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10837	Morphine	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment(i) is less than 12 months; or(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10858	Morphine	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V10891	Morphine	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V11696	FentanylMethadone	Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V11697	HydromorphoneMorphine	Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V11753	BuprenorphineMorphineOxycodoneOxycodone with naloxone	Authority requests for treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V13377	Burosumab	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V13977	Vosoritide	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V13998	Vosoritide	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V14667	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V14718	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V14842	Desmopressin	No more than twice the maximum quantity will be authorised.
V14945	Desmopressin	No increase in the maximum quantity or number of units may be authorised.
V14972	Desmopressin	No more than twice the maximum quantity will be authorised.
V15025	Desmopressin	No increase in the maximum quantity or number of units may be authorised.
V15303	Tafamidis	If heart failure has worsened to NYHA Class III/IV since the last authority application, no more than 2 repeat prescriptions must be prescribed.
V15456	Midazolam	At the time of the authority application, practitioners should request the appropriate quantity to cater for the patient's circumstances.Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.
V15818	Trastuzumab emtansine	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15819	Trastuzumab emtansine	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15820	Trastuzumab	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15826	Trastuzumab deruxtecan	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15827	Trastuzumab emtansine	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15828	Trastuzumab emtansine	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15831	Trastuzumab	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15832	Trastuzumab deruxtecan	Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg
V15994	FentanylMethadone	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment: (i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or (ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or (iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V15996	FentanylMethadone	Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non-PBS and PBS opioid analgesic treatment is less than 12 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V16000	FentanylMethadone	Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non-PBS and PBS opioid analgesic treatment: (i) is less than 12 months; or (ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or (iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or (iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia. Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats).
V17616	Toripalimab	An increase above the listed maximum amount may only be requested when a dose of 3 mg/kg every 2 weeks is prescribed in the second line setting.
V18196	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V18263	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V18340	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V18370	Nivolumab	An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.
V18377	Elranatamab	Prescribers may request the number of vials in line with the dosing requirement for each stage of treatment with the intention of providing the number of vials for each 4-weeks of treatment (24-weeks of treatment including repeats). Up to 4 vials with 5 repeats may be requested for a patient undergoing treatment in weeks 2-26. Up to 2 vials with 5 repeats may be requested for a patient undergoing treatment from week 27 onwards. Requests beyond what is listed in the TGA approved product information will not be approved.
V18774	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V18775	Infliximab	A maximum quantity and number of repeats to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered every 8 weeks will be authorised.
V18819	Infliximab	A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.
V18826	Ustekinumab	A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.
V18840	Midazolam	At the time of the authority application, medical practitioners should request the appropriate quantity to cater for the patient's circumstances. Up to a maximum of 10 syringes for each prescription can be authorised for patients with high frequency seizures.
V18849	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V18866	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V18868	Infliximab	A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.
V18885	Ustekinumab	A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.
V18929	Pegunigalsidase alfa	At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).
V18930	Pegunigalsidase alfa	At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).
V18950	Burosumab	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V18952	Burosumab	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V18953	Burosumab	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V18982	Burosumab	At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
V18992	Infliximab	An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.
V18994	Infliximab	An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.
V18995	Infliximab	An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight with 3 repeats will be authorised.
V19011	Infliximab	An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight will be authorised. An increase in maximum repeats to 5 may be requested.
V19015	Pegunigalsidase alfa	At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).
V19042	Infliximab	An increase in the maximum quantity to allow for dosing of up to 10 mg per kg body weight will be authorised. An increase in maximum repeats to 5 may be requested.
V19045	Pegunigalsidase alfa	At the time of authority application, prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment at the dosage regimen specified in the approved Therapeutic Goods Administration (TGA) Product Information (PI).
V19071	Pegvisomant	No increase in the maximum quantity or number of units may be authorised for the loading dose.
V19107	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V19108	Infliximab	A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
V19150	Infliximab	A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.
V19152	Infliximab	A maximum quantity and number of repeats to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered every 8 weeks will be authorised.
V19193	Ustekinumab	A maximum number of repeats of this drug consisting of up to 1 repeat for patients whose dosing frequency is every 12 weeks and up to 2 repeats for patients whose dosing frequency is every 8 weeks, will be authorised.
V19207	Infliximab	A maximum quantity to provide for each continuing course of this drug consisting of 3 doses at 5 mg per kg body weight per dose will be authorised.

Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.