Contents

• 1. Name
• 2. Commencement
• 3. Authority
• 4. Schedules

1. Name#

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (November Update) Instrument 2026.

(2)This Instrument may also be cited as PB 130 of 2026.

2. Commencement#

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 November 2026	1 November 2026

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3. Authority#

This instrument is made under subsection 100(2) of the National Health Act 1953.

4. Schedules#

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

[1] Schedule 1

omit table and substitute:

Listed drug	Form	Manner of administration	Brand	Nurse prescribing	Circumstances	Purposes	Maximum quantity	Maximum repeats
Abacavir	Oral solution 20 mg (as sulfate) per mL, 240 mL	Oral	Ziagen	NP	C13920		8	5
Abacavir	Tablet 300 mg (as sulfate)	Oral	Ziagen	NP	C4454 C4512		120	5
Abacavir with lamivudine	Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg	Oral	Abacavir/Lamivudine Viatris	NP	C4527 C4528		60	5
Abatacept	Powder for I.V. infusion 250 mg	Injection	Orencia		C14488 C14507 C14555 C14604 C18169 C18272 C18273 C18274		See Schedule 2	See Schedule 2
Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Amgevita		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Humira		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 20 mg in 0.2 mL pre-filled syringe	Injection	Yuflyma		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 20 mg in 0.4 mL pre-filled syringe	Injection	Amgevita		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Amgevita		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Hadlima		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Humira		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Hyrimoz		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled pen	Injection	Yuflyma		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Hadlima		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Humira		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Hyrimoz		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.4 mL pre-filled syringe	Injection	Yuflyma		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Abrilada		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Amgevita		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Hadlima		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled pen	Injection	Hyrimoz		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Amgevita		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Hadlima		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Adalimumab	Injection 40 mg in 0.8 mL pre-filled syringe	Injection	Hyrimoz		C12120 C17707 C17713 C17717 C17719 C17733 C17734		See Schedule 2	See Schedule 2
Alemtuzumab	Solution concentrate for I.V. infusion 12 mg in 1.2 mL	Injection	Lemtrada		C6847 C9589	P6847 P9589	3	0
Alemtuzumab	Solution concentrate for I.V. infusion 12 mg in 1.2 mL	Injection	Lemtrada		C7714 C9636	P7714 P9636	5	0
Ambrisentan	Tablet 5 mg	Oral	Ambrisentan Viatris		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Ambrisentan	Tablet 5 mg	Oral	PULMORIS		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Ambrisentan	Tablet 5 mg	Oral	Volibris		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Ambrisentan	Tablet 10 mg	Oral	Ambrisentan Viatris		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Ambrisentan	Tablet 10 mg	Oral	Cipla Ambrisentan		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Ambrisentan	Tablet 10 mg	Oral	PULMORIS		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Ambrisentan	Tablet 10 mg	Oral	Volibris		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Anakinra	Injection 100 mg in 0.67 mL single use pre-filled syringe	Injection	Kineret		C5450		28	5
Anifrolumab	Solution concentrate for I.V. infusion 300 mg in 2 mL	Injection	Saphnelo		C19096 C19216		See Schedule 2	See Schedule 2
Apomorphine	Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL	Injection	Movapo		C11385 C11445		180	5
Apomorphine	Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL	Injection	Apomine Solution for Infusion		C10830 C10863		90	5
Apomorphine	Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL	Injection	MOVAPO POD		C10830 C10863		90	5
Apomorphine	Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe	Injection	Movapo PFS		C11385 C11445		180	5
Apomorphine	Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen	Injection	Apomine Intermittent		C10830 C10863		100	5
Apomorphine	Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen	Injection	Movapo Pen		C10830 C10863		100	5
Atazanavir with cobicistat	Tablet containing 300 mg atazanavir and 150 mg cobicistat	Oral	Evotaz	NP	C4454 C4512		60	5
Avatrombopag	Tablet 20 mg	Oral	Doptelet		C14054 C15340 C15375 C18297		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine Accord		C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine Dr.Reddy's		C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine Juno		C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine MSN		C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
Azacitidine	Powder for injection 100 mg	Injection	Azacitidine SXP		C12439 C12983 C12986 C13010 C13011 C13012 C13015 C19124		See Schedule 2	See Schedule 2
Azithromycin	Tablet 600 mg (as dihydrate)	Oral	Zithromax	NP	C6356 C9604		16	5
Baclofen	Intrathecal injection 10 mg in 5 mL	Injection	Bacthecal		C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
Baclofen	Intrathecal injection 10 mg in 5 mL	Injection	Lioresal Intrathecal		C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
Baclofen	Intrathecal injection 10 mg in 5 mL	Injection	Sintetica Baclofen Intrathecal		C6911 C6925 C6939 C6940 C9488 C9489 C9524 C9637		10	0
Baclofen	Intrathecal injection 40 mg in 20 mL	Injection	Sintetica Baclofen Intrathecal		C7134 C7148 C7152 C7153 C9525 C9562 C9606 C9638		2	0
Benralizumab	Injection 30 mg in 1 mL single dose pre-filled pen	Injection	Fasenra Pen		C15376 C19082 C19128 C19130		See Schedule 2	See Schedule 2
Bictegravir with emtricitabine with tenofovir alafenamide	Tablet containing bictegravir 50 mg with emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Biktarvy	NP	C4470 C4522		60	5
Bosentan	Tablet 62.5 mg (as monohydrate)	Oral	Bosentan APO		C11229 C12425 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 62.5 mg (as monohydrate)	Oral	BOSENTAN DR.REDDY'S		C11229 C12425 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 62.5 mg (as monohydrate)	Oral	Bosentan RBX		C11229 C12425 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 125 mg (as monohydrate)	Oral	Bosentan APO		C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 125 mg (as monohydrate)	Oral	BOSENTAN DR.REDDY'S		C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 125 mg (as monohydrate)	Oral	Bosentan GH		C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 125 mg (as monohydrate)	Oral	Bosentan RBX		C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Bosentan	Tablet 125 mg (as monohydrate)	Oral	Bosentan Viatris		C11229 C13497 C13571 C18737 C18738 C18743 C18752 C18833		See Schedule 2	See Schedule 2
Buprenorphine	Injection (modified release) 8 mg in 0.16 mL pre-filled syringe	Injection	Buvidal Weekly	NP	C16051		4	5
Buprenorphine	Injection (modified release) 16 mg in 0.32 mL pre-filled syringe	Injection	Buvidal Weekly	NP	C16051		4	5
Buprenorphine	Injection (modified release) 24 mg in 0.48 mL pre-filled syringe	Injection	Buvidal Weekly	NP	C16051		4	5
Buprenorphine	Injection (modified release) 32 mg in 0.64 mL pre-filled syringe	Injection	Buvidal Weekly	NP	C16051		4	5
Buprenorphine	Injection (modified release) 64 mg in 0.18 mL pre-filled syringe	Injection	Buvidal Monthly	NP	C16015		1	5
Buprenorphine	Injection (modified release) 96 mg in 0.27 mL pre-filled syringe	Injection	Buvidal Monthly	NP	C16015		1	5
Buprenorphine	Injection (modified release) 100 mg in 0.5 mL pre-filled syringe	Injection	Sublocade	NP	C16050		1	5
Buprenorphine	Injection (modified release) 128 mg in 0.36 mL pre-filled syringe	Injection	Buvidal Monthly	NP	C16015		1	5
Buprenorphine	Injection (modified release) 160 mg in 0.45 mL pre-filled syringe	Injection	Buvidal Monthly	NP	C16015		1	5
Buprenorphine	Injection (modified release) 300 mg in 1.5 mL pre-filled syringe	Injection	Sublocade	NP	C16050		1	5
Buprenorphine	Tablet (sublingual) 400 micrograms (as hydrochloride)	Sublingual	Subutex	NP	C16009		28	5
Buprenorphine	Tablet (sublingual) 2 mg (as hydrochloride)	Sublingual	Subutex	NP	C16009		84	5
Buprenorphine	Tablet (sublingual) 8 mg (as hydrochloride)	Sublingual	Subutex	NP	C16009		112	5
Buprenorphine with naloxone	Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride)	Sublingual	Suboxone Film 2/0.5	NP	C16009		84	5
Buprenorphine with naloxone	Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride)	Sublingual	Suboxone Film 8/2	NP	C16009		112	5
Burosumab	Solution for injection 10 mg in 1 mL	Injection	Crysvita		C13377 C18950 C18952 C18953 C18982		See Schedule 2	See Schedule 2
Burosumab	Solution for injection 20 mg in 1 mL	Injection	Crysvita		C13377 C18950 C18952 C18953 C18982		See Schedule 2	See Schedule 2
Burosumab	Solution for injection 30 mg in 1 mL	Injection	Crysvita		C13377 C18950 C18952 C18953 C18982		See Schedule 2	See Schedule 2
Cabotegravir	Tablet 30 mg	Oral	Vocabria	NP	C12619		30	0
Cabotegravir and rilpivirine	Pack containing 1 vial cabotegravir 600 mg in 3 mL and 1 vial rilpivirine 900 mg in 3 mL	Injection	Cabenuva	NP	C12636		1	5
Ciclosporin	Capsule 10 mg	Oral	Neoral 10	NP	C19414 C19511		120	5
Ciclosporin	Capsule 10 mg	Oral	Neoral 10		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 25 mg	Oral	APO-Ciclosporin	NP	C19414 C19511		120	5
Ciclosporin	Capsule 25 mg	Oral	APO-Ciclosporin		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 25 mg	Oral	CICLOSPORIN-WGR	NP	C19414 C19511		120	5
Ciclosporin	Capsule 25 mg	Oral	CICLOSPORIN-WGR		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 25 mg	Oral	Neoral 25	NP	C19414 C19511		120	5
Ciclosporin	Capsule 25 mg	Oral	Neoral 25		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 50 mg	Oral	APO-Ciclosporin	NP	C19414 C19511		120	5
Ciclosporin	Capsule 50 mg	Oral	APO-Ciclosporin		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 50 mg	Oral	CICLOSPORIN-WGR	NP	C19414 C19511		120	5
Ciclosporin	Capsule 50 mg	Oral	CICLOSPORIN-WGR		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 50 mg	Oral	Neoral 50	NP	C19414 C19511		120	5
Ciclosporin	Capsule 50 mg	Oral	Neoral 50		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 100 mg	Oral	APO-Ciclosporin	NP	C19414 C19511		120	5
Ciclosporin	Capsule 100 mg	Oral	APO-Ciclosporin		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 100 mg	Oral	CICLOSPORIN-WGR	NP	C19414 C19511		120	5
Ciclosporin	Capsule 100 mg	Oral	CICLOSPORIN-WGR		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Capsule 100 mg	Oral	Neoral 100	NP	C19414 C19511		120	5
Ciclosporin	Capsule 100 mg	Oral	Neoral 100		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		120	5
Ciclosporin	Oral liquid 100 mg per mL, 50 mL	Oral	Neoral	NP	C19414 C19511		4	5
Ciclosporin	Oral liquid 100 mg per mL, 50 mL	Oral	Neoral		C6631 C6660 C9694 C9695 C15360 C15361 C19423 C19482		4	5
Ciclosporin	Solution concentrate for I.V. infusion 50 mg in 1 mL	Injection	Sandimmun	NP	C19424 C19503		10	0
Cinacalcet	Tablet 30 mg (as hydrochloride)	Oral	Cinacalcet Viatris		C10063 C10067 C10073		56	5
Cinacalcet	Tablet 30 mg (as hydrochloride)	Oral	Pharmacor Cinacalcet		C10063 C10067 C10073		56	5
Cinacalcet	Tablet 60 mg (as hydrochloride)	Oral	Cinacalcet Viatris		C10063 C10067 C10073		56	5
Cinacalcet	Tablet 60 mg (as hydrochloride)	Oral	Pharmacor Cinacalcet		C10063 C10067 C10073		56	5
Cinacalcet	Tablet 90 mg (as hydrochloride)	Oral	Cinacalcet Viatris		C10063 C10067 C10073		56	5
Cinacalcet	Tablet 90 mg (as hydrochloride)	Oral	Pharmacor Cinacalcet		C10063 C10067 C10073		56	5
Clozapine	Oral liquid 50 mg per mL, 100 mL	Oral	Clopine Suspension	NP	C19470		1	0
Clozapine	Oral liquid 50 mg per mL, 100 mL	Oral	Clopine Suspension		C5015 C9490		1	0
Clozapine	Oral liquid 50 mg per mL, 100 mL	Oral	Versacloz	NP	C19507		1	0
Clozapine	Oral liquid 50 mg per mL, 100 mL	Oral	Versacloz		C5015 C9490		1	0
Clozapine	Tablet 25 mg	Oral	Clopine 25	NP	C19469		200	0
Clozapine	Tablet 25 mg	Oral	Clopine 25		C5015 C9490		200	0
Clozapine	Tablet 25 mg	Oral	Clozaril 25	NP	C19469		200	0
Clozapine	Tablet 25 mg	Oral	Clozaril 25		C5015 C9490		200	0
Clozapine	Tablet 25 mg	Oral	Clozitor	NP	C19469		200	0
Clozapine	Tablet 25 mg	Oral	Clozitor		C5015 C9490		200	0
Clozapine	Tablet 50 mg	Oral	Clopine 50	NP	C19290		200	0
Clozapine	Tablet 50 mg	Oral	Clopine 50		C5015 C9490		200	0
Clozapine	Tablet 50 mg	Oral	Clozitor	NP	C19290		200	0
Clozapine	Tablet 50 mg	Oral	Clozitor		C5015 C9490		200	0
Clozapine	Tablet 100 mg	Oral	Clopine 100	NP	C19467		200	0
Clozapine	Tablet 100 mg	Oral	Clopine 100		C5015 C9490		200	0
Clozapine	Tablet 100 mg	Oral	Clozaril 100	NP	C19467		200	0
Clozapine	Tablet 100 mg	Oral	Clozaril 100		C5015 C9490		200	0
Clozapine	Tablet 100 mg	Oral	Clozitor	NP	C19467		200	0
Clozapine	Tablet 100 mg	Oral	Clozitor		C5015 C9490		200	0
Clozapine	Tablet 200 mg	Oral	Clopine 200	NP	C19429		200	0
Clozapine	Tablet 200 mg	Oral	Clopine 200		C5015 C9490		200	0
Clozapine	Tablet 200 mg	Oral	Clozitor	NP	C19429		200	0
Clozapine	Tablet 200 mg	Oral	Clozitor		C5015 C9490		200	0
Darbepoetin alfa	Injection 10 micrograms in 0.4 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 20 micrograms in 0.5 mL pre-filled injection pen	Injection	Aranesp SureClick	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 20 micrograms in 0.5 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 30 micrograms in 0.3 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 40 micrograms in 0.4 mL pre-filled injection pen	Injection	Aranesp SureClick	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 40 micrograms in 0.4 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 50 micrograms in 0.5 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 60 micrograms in 0.3 mL pre-filled injection pen	Injection	Aranesp SureClick	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 60 micrograms in 0.3 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 80 micrograms in 0.4 mL pre-filled injection pen	Injection	Aranesp SureClick	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 80 micrograms in 0.4 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 100 micrograms in 0.5 mL pre-filled injection pen	Injection	Aranesp SureClick	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 100 micrograms in 0.5 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 150 micrograms in 0.3 mL pre-filled injection pen	Injection	Aranesp SureClick	NP	C6294 C9688		8	5
Darbepoetin alfa	Injection 150 micrograms in 0.3 mL pre-filled syringe	Injection	Aranesp	NP	C6294 C9688		8	5
Darunavir	Tablet 600 mg	Oral	Darunavir Juno	NP	C5094		120	5
Darunavir	Tablet 600 mg (as ethanolate)	Oral	Prezista	NP	C5094		120	5
Darunavir	Tablet 800 mg	Oral	Darunavir Juno	NP	C4313		60	5
Darunavir	Tablet 800 mg (as ethanolate)	Oral	Prezista	NP	C4313		60	5
Darunavir with cobicistat	Tablet containing darunavir 800 mg with cobicistat 150 mg	Oral	Prezcobix	NP	C6377 C6413 C6428		60	5
Darunavir with cobicistat, emtricitabine and tenofovir alafenamide	Tablet containing darunavir 800 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg	Oral	Symtuza	NP	C10317 C10324		60	5
Deferasirox	Tablet 90 mg	Oral	DEFERAMED	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	DEFERAMED	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 90 mg	Oral	Deferasirox ARX	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	Deferasirox ARX	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 90 mg	Oral	Deferasirox Sandoz	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	Deferasirox Sandoz	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 90 mg	Oral	DEFERASIROX-TEVA	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	DEFERASIROX-TEVA	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 90 mg	Oral	Eferas	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	Eferas	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 90 mg	Oral	Jadenu	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	Jadenu	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 90 mg	Oral	Pharmacor Deferasirox FC	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 90 mg	Oral	Pharmacor Deferasirox FC	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	DEFERAMED	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	DEFERAMED	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	Deferasirox ARX	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	Deferasirox ARX	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	Deferasirox Sandoz	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	Deferasirox Sandoz	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	DEFERASIROX-TEVA	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	DEFERASIROX-TEVA	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	Eferas	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	Eferas	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	Jadenu	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	Jadenu	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 180 mg	Oral	Pharmacor Deferasirox FC	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 180 mg	Oral	Pharmacor Deferasirox FC	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	DEFERAMED	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	DEFERAMED	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	Deferasirox ARX	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	Deferasirox ARX	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	Deferasirox FCT MSN	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	Deferasirox FCT MSN	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	Deferasirox Sandoz	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	Deferasirox Sandoz	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	DEFERASIROX-TEVA	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	DEFERASIROX-TEVA	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	Eferas	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	Eferas	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	Jadenu	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	Jadenu	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet 360 mg	Oral	Pharmacor Deferasirox FC	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	180	2
Deferasirox	Tablet 360 mg	Oral	Pharmacor Deferasirox FC	NP	C19312 C19318	P19312 P19318	180	5
Deferasirox	Tablet, dispersible, 125 mg	Oral	Deferasirox Juno	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	168	2
Deferasirox	Tablet, dispersible, 125 mg	Oral	Deferasirox Juno	NP	C19312 C19318	P19312 P19318	168	5
Deferasirox	Tablet, dispersible, 250 mg	Oral	Deferasirox Juno	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	168	2
Deferasirox	Tablet, dispersible, 250 mg	Oral	Deferasirox Juno	NP	C19312 C19318	P19312 P19318	168	5
Deferasirox	Tablet, dispersible, 500 mg	Oral	Deferasirox Juno	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	168	2
Deferasirox	Tablet, dispersible, 500 mg	Oral	Deferasirox Juno	NP	C19312 C19318	P19312 P19318	168	5
Deferasirox	Tablet, dispersible, 500 mg	Oral	Pharmacor Deferasirox	NP	C19286 C19311 C19375 C19384 C19386 C19439 C19506	P19286 P19311 P19375 P19384 P19386 P19439 P19506	168	2
Deferasirox	Tablet, dispersible, 500 mg	Oral	Pharmacor Deferasirox	NP	C19312 C19318	P19312 P19318	168	5
Deferiprone	Oral solution 100 mg per mL, 250 mL	Oral	Ferriprox	NP	C19310 C19436 C19437 C19492		5	5
Deferiprone	Tablet 500 mg	Oral	Ferriprox	NP	C19310 C19436 C19437 C19492		300	5
Deferiprone	Tablet 1000 mg	Oral	Ferriprox	NP	C19310 C19436 C19437 C19492		300	5
Desferrioxamine	Powder for injection containing desferrioxamine mesilate 500 mg	Injection	DBL Desferrioxamine Mesilate	NP	C19476 C19477		400	5
Desferrioxamine	Powder for injection containing desferrioxamine mesilate 2 g	Injection	DBL Desferrioxamine Mesilate	NP	C19476 C19477		60	5
Difelikefalin	Solution for I.V. injection 50 micrograms (as acetate) in 1 mL	Injection	Korsuva		C15171 C15211		See Schedule 2	See Schedule 2
Dolutegravir	Tablet 50 mg (as sodium)	Oral	Tivicay	NP	C4454 C4512		60	5
Dolutegravir with abacavir and lamivudine	Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg	Oral	Triumeq	NP	C9981 C10116		60	5
Dolutegravir with lamivudine	Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg	Oral	Dovato	NP	C9987 C11066		60	5
Dolutegravir with rilpivirine	Tablet containing dolutegravir 50 mg (as sodium) with rilpivirine 25 mg (as hydrochloride)	Oral	Juluca	NP	C8214 C8226		60	5
Dornase alfa	Solution for inhalation 2.5 mg (2,500 units) in 2.5 mL	Inhalation	Pulmozyme	NP	C19378 C19432 C19546 C19554 C19559 C19563		60	5
Doxorubicin - pegylated liposomal	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	Caelyx	NP	C6234 C6274 C9223 C9287		4	5
Doxorubicin - pegylated liposomal	Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL	Injection	Liposomal Doxorubicin SUN	NP	C6234 C6274 C9223 C9287		4	5
Dupilumab	Injection 200 mg in 1.14 mL single dose pre-filled pen	Injection	Dupixent		C17009 C19091 C19137 C19236		See Schedule 2	See Schedule 2
Dupilumab	Injection 200 mg in 1.14 mL single dose pre-filled syringe	Injection	Dupixent		C17009 C19091 C19136 C19137 C19181 C19213 C19236		See Schedule 2	See Schedule 2
Dupilumab	Injection 300 mg in 2 mL single dose pre-filled pen	Injection	Dupixent		C17009 C19091 C19137 C19236		See Schedule 2	See Schedule 2
Dupilumab	Injection 300 mg in 2 mL single dose pre-filled syringe	Injection	Dupixent		C17009 C19091 C19132 C19133 C19136 C19137 C19236		See Schedule 2	See Schedule 2
Eculizumab	Solution concentrate for I.V. infusion 300 mg in 30 mL	Injection	Soliris		C14750 C14792 C17602 C17626 C17630 C17651 C17673 C17675 C17684 C17693 C17697 C19249 C19258 C19263 C19270 C19273 C19274		See Schedule 2	See Schedule 2
Edaravone	Solution concentrate for I.V. infusion 30 mg in 20 mL	Injection	Radicava		C19267	P19267	20	2
Edaravone	Solution concentrate for I.V. infusion 30 mg in 20 mL	Injection	Radicava		C19252	P19252	28	0
Eflornithine	Tablet 192 mg (as hydrochloride)	Oral	Ifinwil		C16841 C17753		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 28 sachets containing granules elexacaftor 80 mg with tezacaftor 40 mg and with ivacaftor 60 mg and 28 sachets containing granules ivacaftor 59.5 mg	Oral	Trikafta	NP	C19473		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 28 sachets containing granules elexacaftor 80 mg with tezacaftor 40 mg and with ivacaftor 60 mg and 28 sachets containing granules ivacaftor 59.5 mg	Oral	Trikafta		C17772		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg	Oral	Trikafta	NP	C19433		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 28 sachets containing granules elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 sachets containing granules ivacaftor 75 mg	Oral	Trikafta		C17846		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 56 tablets elexacaftor 50 mg with tezacaftor 25 mg and with ivacaftor 37.5 mg and 28 tablets ivacaftor 75 mg	Oral	Trikafta	NP	C19433		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 56 tablets elexacaftor 50 mg with tezacaftor 25 mg and with ivacaftor 37.5 mg and 28 tablets ivacaftor 75 mg	Oral	Trikafta		C17846		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg	Oral	Trikafta	NP	C19435		See Schedule 2	See Schedule 2
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor	Pack containing 56 tablets elexacaftor 100 mg with tezacaftor 50 mg and with ivacaftor 75 mg and 28 tablets ivacaftor 150 mg	Oral	Trikafta		C17970		See Schedule 2	See Schedule 2
Eltrombopag	Tablet 25 mg (as olamine)	Oral	Revolade		C13327 C14127 C14129 C15173 C16455 C18209 C18210		See Schedule 2	See Schedule 2
Eltrombopag	Tablet 50 mg (as olamine)	Oral	Revolade		C13327 C14127 C14129 C15173 C16455 C18209 C18210		See Schedule 2	See Schedule 2
Emtricitabine with rilpivirine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg	Oral	Odefsey	NP	C4470 C4522		60	5
Emtricitabine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg	Oral	Descovy	NP	C4454 C4512		60	5
Emtricitabine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Descovy	NP	C4454 C4512		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	ENTAC	NP	C4993 C5036		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	ENTECAVIR APO	NP	C4993 C5036		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	Entecavir GH	NP	C4993 C5036		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	ENTECAVIR RBX	NP	C4993 C5036		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	Entecavir Sandoz	NP	C4993 C5036		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	Entecavir Viatris	NP	C4993 C5036		60	5
Entecavir	Tablet 0.5 mg (as monohydrate)	Oral	ENTECAVIR-WGR	NP	C4993 C5036		60	5
Entecavir	Tablet 1 mg (as monohydrate)	Oral	ENTECAVIR APO	NP	C5037 C5044		60	5
Entecavir	Tablet 1 mg (as monohydrate)	Oral	ENTECAVIR RBX	NP	C5037 C5044		60	5
Entecavir	Tablet 1 mg (as monohydrate)	Oral	Entecavir Sandoz	NP	C5037 C5044		60	5
Entecavir	Tablet 1 mg (as monohydrate)	Oral	Entecavir Viatris	NP	C5037 C5044		60	5
Entecavir	Tablet 1 mg (as monohydrate)	Oral	ENTECAVIR-WGR	NP	C5037 C5044		60	5
Epoetin alfa	Injection 1,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 1000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 2,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 2000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 3,000 units in 0.3 mL pre-filled syringe	Injection	Eprex 3000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 4,000 units in 0.4 mL pre-filled syringe	Injection	Eprex 4000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 5,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 5000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 6,000 units in 0.6 mL pre-filled syringe	Injection	Eprex 6000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 8,000 units in 0.8 mL pre-filled syringe	Injection	Eprex 8000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 10,000 units in 1 mL pre-filled syringe	Injection	Eprex 10000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 20,000 units in 0.5 mL pre-filled syringe	Injection	Eprex 20,000	NP	C6294 C9688		12	5
Epoetin alfa	Injection 40,000 units in 1 mL pre-filled syringe	Injection	Eprex 40,000	NP	C6294 C9688		2	5
Epoetin lambda	Injection 1,000 units in 0.5 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 2,000 units in 1 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 3,000 units in 0.3 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 4,000 units in 0.4 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 5,000 units in 0.5 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 6,000 units in 0.6 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 8,000 units in 0.8 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoetin lambda	Injection 10,000 units in 1 mL pre-filled syringe	Injection	Novicrit	NP	C6294 C9688		12	5
Epoprostenol	Powder for I.V. infusion 500 micrograms (as sodium)	Injection	Veletri		C13491 C13506 C13577 C18208 C18401 C18802 C18859		See Schedule 2	See Schedule 2
Epoprostenol	Powder for I.V. infusion 1.5 mg (as sodium)	Injection	Veletri		C13491 C13506 C13577 C18208 C18401 C18802 C18859		See Schedule 2	See Schedule 2
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato		C16460	P16460	4	5
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato		C16477	P16477	8	0
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato		C16470	P16470	8	5
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato		C16419	P16419	12	5
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato		C16422	P16422	16	0
Esketamine	Nasal spray device 28 mg in 2 actuations	Nasal	Spravato		C16454	P16454	24	0
Etanercept	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Enbrel		C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etanercept	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Erelzi		C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etanercept	Injection 50 mg in 1 mL single use auto-injector, 4	Injection	Nepexto		C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etanercept	Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL	Injection	Enbrel		C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etanercept	Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Enbrel		C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etanercept	Injections 50 mg in 1 mL single use pre-filled syringes, 4	Injection	Erelzi		C12120 C17706 C17707 C17713 C17724 C17725		See Schedule 2	See Schedule 2
Etravirine	Tablet 200 mg	Oral	Intelence	NP	C5014		120	5
Everolimus	Tablet 0.25 mg	Oral	Certican	NP	C19365 C19366 C19370 C19459		120	5
Everolimus	Tablet 0.25 mg	Oral	Everocan	NP	C19365 C19366 C19370 C19459		120	5
Everolimus	Tablet 0.5 mg	Oral	Certican	NP	C19365 C19366 C19370 C19459		120	5
Everolimus	Tablet 0.5 mg	Oral	Everocan	NP	C19365 C19366 C19370 C19459		120	5
Everolimus	Tablet 0.75 mg	Oral	Certican	NP	C19365 C19366 C19370 C19459		240	5
Everolimus	Tablet 0.75 mg	Oral	Everocan	NP	C19365 C19366 C19370 C19459		240	5
Everolimus	Tablet 1 mg	Oral	Certican	NP	C19365 C19366 C19370 C19459		240	5
Everolimus	Tablet 1 mg	Oral	Everocan	NP	C19365 C19366 C19370 C19459		240	5
Filgrastim	Injection 120 micrograms in 0.2 mL single-use pre-filled syringe	Injection	Nivestim	NP	C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447		20	11
Filgrastim	Injection 300 micrograms in 0.5 mL single-use pre-filled syringe	Injection	Nivestim	NP	C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447		20	11
Filgrastim	Injection 300 micrograms in 0.5 mL single-use pre-filled syringe	Injection	Zarzio	NP	C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447		20	11
Filgrastim	Injection 480 micrograms in 0.5 mL single-use pre-filled syringe	Injection	Nivestim	NP	C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447		20	11
Filgrastim	Injection 480 micrograms in 0.5 mL single-use pre-filled syringe	Injection	Zarzio	NP	C19325 C19326 C19327 C19330 C19332 C19333 C19334 C19339 C19340 C19392 C19395 C19397 C19398 C19399 C19400 C19403 C19443 C19447		20	11
Foslevodopa with foscarbidopa	Solution for subcutaneous infusion containing foslevodopa 2400 mg with foscarbidopa 120 mg in 10 mL	Injection	Vyalev		C16812 C16883	P16812 P16883	28	5
Foslevodopa with foscarbidopa	Solution for subcutaneous infusion containing foslevodopa 2400 mg with foscarbidopa 120 mg in 10 mL	Injection	Vyalev		C16853 C16972	P16853 P16972	56	5
Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	Cymevene	NP	C5000		10	1
Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	Cymevene		C15782 C15784 C15800 C15814		10	1
Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	GANCICLOVIR SXP	NP	C5000		10	1
Ganciclovir	Powder for I.V. infusion 500 mg (as sodium)	Injection	GANCICLOVIR SXP		C15782 C15784 C15800 C15814		10	1
Glecaprevir with pibrentasvir	Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir	Oral	Maviret	NP	C7593	P7593	84	1
Glecaprevir with pibrentasvir	Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir	Oral	Maviret	NP	C7615	P7615	84	2
Glecaprevir with pibrentasvir	Tablet containing 100 mg glecaprevir with 40 mg pibrentasvir	Oral	Maviret	NP	C10268	P10268	84	3
Iloprost	Solution for inhalation 20 micrograms (as trometamol) in 2 mL	Inhalation	Ventavis		C13491 C13506 C13577 C18294 C18403 C18802 C18859		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Inflectra		C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Ixifi		C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Remicade		C4524 C8296 C9068 C9111 C9559 C9632 C9754 C11158 C12059 C14504 C14505 C14507 C14548 C14705 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18849 C18866 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19152 C19176		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Remsima		C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
Infliximab	Powder for I.V. infusion 100 mg	Injection	Renflexis		C4524 C8296 C8844 C8940 C9068 C9111 C9188 C9472 C9559 C9584 C9602 C9632 C9754 C11158 C12042 C12059 C12074 C14502 C14504 C14505 C14507 C14544 C14548 C14585 C14623 C14638 C14667 C14683 C14689 C14701 C14705 C14707 C14718 C14723 C18158 C18162 C18164 C18165 C18191 C18192 C18194 C18196 C18263 C18267 C18287 C18340 C18343 C18345 C18352 C18355 C18391 C18431 C18436 C18437 C18439 C18441 C18462 C18468 C18469 C18470 C18502 C18774 C18775 C18776 C18819 C18849 C18866 C18868 C18992 C18993 C18994 C18995 C19011 C19042 C19107 C19108 C19150 C19152 C19176 C19207		See Schedule 2	See Schedule 2
Interferon gamma-1b	Injection 2,000,000 I.U. in 0.5 mL	Injection	Imukin		C6222 C9639		12	11
Ivacaftor	Sachet containing granules 13.4 mg	Oral	Kalydeco		C16928 C16971		See Schedule 2	See Schedule 2
Ivacaftor	Sachet containing granules 25 mg	Oral	Kalydeco	NP	C19296 C19349		See Schedule 2	See Schedule 2
Ivacaftor	Sachet containing granules 25 mg	Oral	Kalydeco		C16844 C16878		See Schedule 2	See Schedule 2
Ivacaftor	Sachet containing granules 50 mg	Oral	Kalydeco	NP	C19296 C19349		See Schedule 2	See Schedule 2
Ivacaftor	Sachet containing granules 50 mg	Oral	Kalydeco		C16844 C16878		See Schedule 2	See Schedule 2
Ivacaftor	Sachet containing granules 75 mg	Oral	Kalydeco	NP	C19296 C19349		See Schedule 2	See Schedule 2
Ivacaftor	Sachet containing granules 75 mg	Oral	Kalydeco		C16844 C16878		See Schedule 2	See Schedule 2
Ivacaftor	Tablet 150 mg	Oral	Kalydeco	NP	C19296 C19349		See Schedule 2	See Schedule 2
Ivacaftor	Tablet 150 mg	Oral	Kalydeco		C16844 C16878		See Schedule 2	See Schedule 2
Lamivudine	Oral solution 10 mg per mL, 240 mL	Oral	3TC	NP	C4454 C4512		8	5
Lamivudine	Tablet 100 mg	Oral	Zeffix	NP	C4993 C5036		56	5
Lamivudine	Tablet 100 mg	Oral	Zetlam	NP	C4993 C5036		56	5
Lamivudine	Tablet 150 mg	Oral	Lamivudine Viatris	NP	C4454 C4512		120	5
Lamivudine	Tablet 150 mg	Oral	3TC	NP	C4454 C4512		120	5
Lamivudine	Tablet 300 mg	Oral	Lamivudine Viatris	NP	C4454 C4512		60	5
Lamivudine	Tablet 300 mg	Oral	3TC	NP	C4454 C4512		60	5
Lamivudine with zidovudine	Tablet 150 mg-300 mg	Oral	Combivir	NP	C4454 C4512		120	5
Lamivudine with zidovudine	Tablet 150 mg-300 mg	Oral	Lamivudine/Zidovudine Viatris 150/300	NP	C4454 C4512		120	5
Lanreotide	Injection 60 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac	NP	C19548 C19552 C19560		2	5
Lanreotide	Injection 60 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac		C7025 C9261 C16024 C16055 C16057		2	5
Lanreotide	Injection 60 mg (as acetate) in single dose pre-filled syringe	Injection	Somatuline Autogel	NP	C19548 C19552 C19560		2	5
Lanreotide	Injection 60 mg (as acetate) in single dose pre-filled syringe	Injection	Somatuline Autogel		C7025 C9261 C16024 C16055 C16057		2	5
Lanreotide	Injection 90 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac	NP	C19548 C19552 C19560		2	5
Lanreotide	Injection 90 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac		C7025 C9261 C16024 C16055 C16057		2	5
Lanreotide	Injection 90 mg (as acetate) in single dose pre-filled syringe	Injection	Somatuline Autogel	NP	C19548 C19552 C19560		2	5
Lanreotide	Injection 90 mg (as acetate) in single dose pre-filled syringe	Injection	Somatuline Autogel		C7025 C9261 C16024 C16055 C16057		2	5
Lanreotide	Injection 120 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac	NP	C19534 C19542 C19547 C19548 C19552 C19560		2	5
Lanreotide	Injection 120 mg (as acetate) in single dose pre-filled syringe	Injection	Mytolac		C7025 C9261 C16024 C16055 C16057 C17638		2	5
Lanreotide	Injection 120 mg (as acetate) in single dose pre-filled syringe	Injection	Somatuline Autogel	NP	C19534 C19542 C19547 C19548 C19552 C19560		2	5
Lanreotide	Injection 120 mg (as acetate) in single dose pre-filled syringe	Injection	Somatuline Autogel		C7025 C9261 C16024 C16055 C16057 C17638		2	5
Lanthanum	Tablet, chewable, 500 mg (as carbonate hydrate)	Oral	Fosrenol		C5530 C9762		180	5
Lanthanum	Tablet, chewable, 750 mg (as carbonate hydrate)	Oral	Fosrenol		C5530 C9762		180	5
Lanthanum	Tablet, chewable, 1000 mg (as carbonate hydrate)	Oral	Fosrenol		C5530 C9762		180	5
Lenalidomide	Capsule 5 mg	Oral	Lenalide		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 5 mg	Oral	Lenalidomide Sandoz		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 5 mg	Oral	Revlimid		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 10 mg	Oral	Lenalide		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 10 mg	Oral	Lenalidomide Sandoz		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 10 mg	Oral	Revlimid		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19065 C19066 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 15 mg	Oral	Lenalide		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 15 mg	Oral	Lenalidomide Sandoz		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 15 mg	Oral	Revlimid		C13782 C13787 C13804 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19076 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 20 mg	Oral	Lenalide		C13782 C13787 C13805 C13811 C13813 C14362 C17414 C18932 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 20 mg	Oral	Lenalidomide Sandoz		C13782 C13787 C13805 C13813 C14362 C17414 C18932 C19062 C19067 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 25 mg	Oral	Lenalide		C13782 C13787 C13805 C13811 C13813 C14362 C17414 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 25 mg	Oral	Lenalidomide Sandoz		C13782 C13787 C13805 C13811 C13813 C14362 C17414 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
Lenalidomide	Capsule 25 mg	Oral	Revlimid		C13782 C13787 C13805 C13811 C13813 C14362 C17414 C19062 C19067 C19079 C19119		See Schedule 2	See Schedule 2
Levodopa with carbidopa	Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL	Intra-intestinal	Duodopa		C10138 C10161	P10138 P10161	28	5
Levodopa with carbidopa	Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL	Intra-intestinal	Duodopa		C10363 C10375	P10363 P10375	56	5
Lipegfilgrastim	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	Lonquex		C7822 C7843 C9224 C9322		1	11
Lopinavir with ritonavir	Oral liquid 400 mg-100 mg per 5 mL, 60 mL	Oral	Kaletra	NP	C4454 C4512		10	5
Lopinavir with ritonavir	Tablet 200 mg-50 mg	Oral	Kaletra	NP	C4454 C4512		240	5
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 75 mg and ivacaftor 94 mg	Oral	Orkambi	NP	C19357		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 75 mg and ivacaftor 94 mg	Oral	Orkambi		C17765		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg	Oral	Orkambi	NP	C19357		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg	Oral	Orkambi		C17765		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg	Oral	Orkambi	NP	C19357		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg	Oral	Orkambi		C17765		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Tablet containing lumacaftor 100 mg with ivacaftor 125 mg	Oral	Orkambi	NP	C19415		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Tablet containing lumacaftor 100 mg with ivacaftor 125 mg	Oral	Orkambi		C17967		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Tablet containing lumacaftor 200 mg with ivacaftor 125 mg	Oral	Orkambi	NP	C19499		See Schedule 2	See Schedule 2
Lumacaftor with ivacaftor	Tablet containing lumacaftor 200 mg with ivacaftor 125 mg	Oral	Orkambi		C17934		See Schedule 2	See Schedule 2
Macitentan	Tablet 10 mg	Oral	Opsumit		C11229 C13497 C13575 C18737 C18741 C18743 C18752 C18836		See Schedule 2	See Schedule 2
Macitentan with tadalafil	Tablet containing 10 mg macitentan with 40 mg tadalafil	Oral	Opsynvi		C16433 C16457		See Schedule 2	See Schedule 2
Mannitol	Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers	Inhalation by mouth	Bronchitol	NP	C19292 C19379 C19380 C19472		4	5
Maraviroc	Tablet 150 mg	Oral	Celsentri	NP	C5008		120	5
Maraviroc	Tablet 150 mg	Oral	Maraviroc Waymade	NP	C5008		120	5
Maraviroc	Tablet 300 mg	Oral	Celsentri	NP	C5008		120	5
Maraviroc	Tablet 300 mg	Oral	Maraviroc Waymade	NP	C5008		120	5
Maribavir	Tablet 200 mg	Oral	Livtencity		C16735 C16806		112	1
Mepolizumab	Injection 100 mg in 1 mL single dose pre-filled pen	Injection	Nucala		C13865 C15376 C19092 C19128 C19139 C19166 C19184 C19198 C19465		See Schedule 2	See Schedule 2
Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL	Oral	Aspen Methadone Syrup	NP	C16083		840	5
Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL	Oral	Biodone Forte	NP	C16083		840	5
Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL	Oral	Aspen Methadone Syrup	NP	C16083		840	5
Methadone	Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL	Oral	Biodone Forte	NP	C16083		840	5
Methoxsalen	Solution for blood fraction 20 microgram per mL, 10 mL	Extracorporeal circulation	Uvadex		C10988 C10989	P10988 P10989	1	5
Methoxsalen	Solution for blood fraction 20 microgram per mL, 10 mL	Extracorporeal circulation	Uvadex		C12531 C12567	P12531 P12567	2	0
Methoxsalen	Solution for blood fraction 20 microgram per mL, 10 mL	Extracorporeal circulation	Uvadex		C10971 C10985	P10971 P10985	2	6
Methoxsalen	Solution for blood fraction 20 microgram per mL, 10 mL	Extracorporeal circulation	Uvadex		C12546 C12579	P12546 P12579	12	1
Methoxy polyethylene glycol-epoetin beta	Injection 30 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Methoxy polyethylene glycol-epoetin beta	Injection 50 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Methoxy polyethylene glycol-epoetin beta	Injection 75 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Methoxy polyethylene glycol-epoetin beta	Injection 100 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Methoxy polyethylene glycol-epoetin beta	Injection 120 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Methoxy polyethylene glycol-epoetin beta	Injection 200 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Methoxy polyethylene glycol-epoetin beta	Injection 360 micrograms in 0.6 mL pre-filled syringe	Injection	Mircera	NP	C6294 C9688		2	5
Midostaurin	Capsule 25 mg	Oral	Rydapt	NP	C19376		See Schedule 2	See Schedule 2
Midostaurin	Capsule 25 mg	Oral	Rydapt		C13001 C19073		See Schedule 2	See Schedule 2
Mycophenolic acid	Capsule containing mycophenolate mofetil 250 mg	Oral	APO-Mycophenolate	NP	C19365 C19366 C19370 C19459		600	5
Mycophenolic acid	Capsule containing mycophenolate mofetil 250 mg	Oral	Mycophenolate Sandoz	NP	C19365 C19366 C19370 C19459		600	5
Mycophenolic acid	Capsule containing mycophenolate mofetil 250 mg	Oral	Pharmacor Mycophenolate 250	NP	C19365 C19366 C19370 C19459		600	5
Mycophenolic acid	Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL	Oral	CellCept	NP	C19365 C19366 C19370 C19459		2	5
Mycophenolic acid	Powder for oral suspension containing mycophenolate mofetil 1 g per 5 mL, 165 mL	Oral	Pharmacor Mycophenolate	NP	C19365 C19366 C19370 C19459		2	5
Mycophenolic acid	Tablet containing mycophenolate mofetil 500 mg	Oral	ARX-MYCOPHENOLATE	NP	C19365 C19366 C19370 C19459		300	5
Mycophenolic acid	Tablet containing mycophenolate mofetil 500 mg	Oral	Ceptolate	NP	C19365 C19366 C19370 C19459		300	5
Mycophenolic acid	Tablet containing mycophenolate mofetil 500 mg	Oral	Mycophenolate GH	NP	C19365 C19366 C19370 C19459		300	5
Mycophenolic acid	Tablet containing mycophenolate mofetil 500 mg	Oral	Mycophenolate Sandoz	NP	C19365 C19366 C19370 C19459		300	5
Mycophenolic acid	Tablet containing mycophenolate mofetil 500 mg	Oral	Pharmacor Mycophenolate 500	NP	C19365 C19366 C19370 C19459		300	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Mycophenolic Acid ARX	NP	C19362 C19485		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Mycophenolic Acid ARX		C4095 C9809		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Myfortic	NP	C19362 C19485		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid	Oral	Myfortic		C4095 C9809		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Mycophenolic Acid ARX	NP	C19362 C19485		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Mycophenolic Acid ARX		C4095 C9809		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	MYCOTEX	NP	C19362 C19485		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	MYCOTEX		C4095 C9809		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Myfortic	NP	C19362 C19485		240	5
Mycophenolic acid	Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid	Oral	Myfortic		C4095 C9809		240	5
Natalizumab	Injection 150 mg in 1 mL single dose pre-filled syringe	Injection	Tysabri		C13625 C13718		2	5
Natalizumab	Solution concentrate for I.V. infusion 300 mg in 15 mL	Injection	Tysabri		C13625 C13718		1	5
Nevirapine	Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL	Oral	Viramune	NP	C4454 C4512		10	5
Nevirapine	Tablet 200 mg	Oral	Nevirapine Viatris	NP	C4454 C4512		120	5
Nitisinone	Capsule 2 mg	Oral	Orfadin		C18958 C19053 C19057		See Schedule 2	See Schedule 2
Nitisinone	Capsule 5 mg	Oral	Orfadin		C18958 C19053 C19057		See Schedule 2	See Schedule 2
Nitisinone	Capsule 10 mg	Oral	Orfadin		C18958 C19053 C19057		See Schedule 2	See Schedule 2
Nitisinone	Capsule 20 mg	Oral	Orfadin		C18958 C19053 C19057		See Schedule 2	See Schedule 2
Nitisinone	Oral suspension 4 mg per mL, 90 mL	Oral	Orfadin		C18959 C19055 C19058		See Schedule 2	See Schedule 2
Nusinersen	Solution for injection 12 mg in 5 mL	Injection	Spinraza		C14433 C14459 C15069 C15112 C18053 C18073 C18076 C18077 C18078 C18094 C18101 C18110		See Schedule 2	See Schedule 2
Obinutuzumab	Solution for I.V. infusion 1000 mg in 40 mL	Injection	Gazyva		C19188	P19188	1	0
Obinutuzumab	Solution for I.V. infusion 1000 mg in 40 mL	Injection	Gazyva		C19168 C19169	P19168 P19169	1	1
Ocrelizumab	Solution concentrate for I.V. infusion 300 mg in 10 mL	Injection	Ocrevus		C7386 C7699 C9523 C9635		2	0
Ocrelizumab	Solution for subcutaneous injection 920 mg in 23 mL	Injection	Ocrevus SC		C7386 C7699 C9523 C9635		1	0
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide GH		C8165 C9233		90	11
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide (SUN)	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Octreotide (SUN)		C8165 C9233		90	11
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Sandostatin 0.05	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 50 micrograms (as acetate) in 1 mL	Injection	Sandostatin 0.05		C8165 C9233		90	11
Octreotide	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide GH		C8165 C9233		90	11
Octreotide	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide (SUN)	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 100 micrograms (as acetate) in 1 mL	Injection	Octreotide (SUN)		C8165 C9233		90	11
Octreotide	Injection 100 micrograms (as acetate) in 1 mL	Injection	Sandostatin 0.1	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 100 micrograms (as acetate) in 1 mL	Injection	Sandostatin 0.1		C8165 C9233		90	11
Octreotide	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide GH	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide GH		C8165 C9233		90	11
Octreotide	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide (SUN)	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 500 micrograms (as acetate) in 1 mL	Injection	Octreotide (SUN)		C8165 C9233		90	11
Octreotide	Injection 500 micrograms (as acetate) in 1 mL	Injection	Sandostatin 0.5	NP	C19321 C19322 C19442 C19479		90	11
Octreotide	Injection 500 micrograms (as acetate) in 1 mL	Injection	Sandostatin 0.5		C8165 C9233		90	11
Octreotide	Injection (modified release) 10 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR	NP	C19533 C19539 C19540 C19543 C19544 C19549		2	5
Octreotide	Injection (modified release) 10 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR		C8161 C8197 C9262		2	5
Octreotide	Injection (modified release) 20 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR	NP	C19533 C19539 C19540 C19543 C19544 C19549		2	5
Octreotide	Injection (modified release) 20 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR		C8161 C8197 C9262		2	5
Octreotide	Injection (modified release) 30 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR	NP	C19533 C19538 C19539 C19540 C19543 C19544 C19549 C19562 C19565		2	5
Octreotide	Injection (modified release) 30 mg (as acetate), vial and diluent syringe	Injection	Sandostatin LAR		C8161 C8197 C9262		2	5
Omalizumab	Injection 75 mg in 0.5 mL single dose pre-filled pen	Injection	Omlyclo		C15376 C19080 C19083 C19135 C19161 C19214		See Schedule 2	See Schedule 2
Omalizumab	Injection 75 mg in 0.5 mL single dose pre-filled pen	Injection	Xolair		C15376 C19080 C19083 C19161		See Schedule 2	See Schedule 2
Omalizumab	Injection 75 mg in 0.5 mL single dose pre-filled syringe	Injection	Omlyclo		C15376 C17012 C17085 C17086 C17102 C19080 C19083 C19135 C19141 C19161 C19163 C19214		See Schedule 2	See Schedule 2
Omalizumab	Injection 75 mg in 0.5 mL single dose pre-filled syringe	Injection	Xolair		C15376 C17012 C17086 C19080 C19083 C19141 C19161 C19163		See Schedule 2	See Schedule 2
Omalizumab	Injection 150 mg in 1 mL single dose pre-filled pen	Injection	Omlyclo		C7046 C15376 C16905 C16906 C16960 C19080 C19083 C19135 C19161 C19214		See Schedule 2	See Schedule 2
Omalizumab	Injection 150 mg in 1 mL single dose pre-filled pen	Injection	Xolair		C7046 C15376 C16906 C19080 C19083 C19161		See Schedule 2	See Schedule 2
Omalizumab	Injection 150 mg in 1 mL single dose pre-filled syringe	Injection	Omlyclo		C7046 C15376 C16905 C16906 C16960 C17012 C17084 C17096 C19080 C19083 C19135 C19141 C19161 C19163 C19214		See Schedule 2	See Schedule 2
Omalizumab	Injection 300 mg in 2 mL single dose pre-filled pen	Injection	Xolair		C7046 C15376 C16906 C19080 C19083 C19161		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 10 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 11 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 12 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 13 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 10 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 11 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 12 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 10 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 11 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 12 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 13 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Onasemnogene abeparvovec	Pack containing 14 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL	Injection	Zolgensma		C19297 C19299 C19302 C19304		See Schedule 2	See Schedule 2
Pamidronic acid	Concentrated injection containing pamidronate disodium 60 mg in 10 mL	Injection	Pamisol		C4433 C9234		1	2
Pamidronic acid	Concentrated injection containing pamidronate disodium 90 mg in 10 mL	Injection	Pamisol		C4433 C5218 C5291 C9234 C9315 C9335		1	11
Pasireotide	Injection (modified release) 20 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR		C19069 C19121		See Schedule 2	See Schedule 2
Pasireotide	Injection (modified release) 40 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR		C19069 C19121		See Schedule 2	See Schedule 2
Pasireotide	Injection (modified release) 60 mg (as embonate), vial and diluent syringe	Injection	Signifor LAR		C19069 C19121		See Schedule 2	See Schedule 2
Pegcetacoplan	Solution for subcutaneous infusion 1,080 mg in 20 mL	Injection	Empaveli		C17598 C17599 C17601 C17622 C17623 C17647 C17683		See Schedule 2	See Schedule 2
Pegfilgrastim	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	Pelgraz	NP	C19332 C19403 C19449 C19508		1	11
Pegfilgrastim	Injection 6 mg in 0.6 mL single use pre-filled syringe	Injection	Ziextenzo	NP	C19332 C19403 C19449 C19508		1	11
Peginterferon alfa-2a	Injection 135 micrograms in 0.5 mL single use pre-filled syringe	Injection	Pegasys	NP	C17022 C17108		8	5
Peginterferon alfa-2a	Injection 135 micrograms in 0.5 mL single use pre-filled syringe (s19A)	Injection	Pegasys (Ireland)	NP	C17022 C17108		8	5
Peginterferon alfa-2a	Injection 180 micrograms in 0.5 mL single use pre-filled syringe	Injection	Pegasys	NP	C17022 C17108		8	5
Peginterferon alfa-2a	Injection 180 micrograms in 0.5 mL single use pre-filled syringe (s19A)	Injection	Pegasys (Ireland)	NP	C17022 C17108		8	5
Pegunigalsidase alfa	Solution for I.V. injection 20 mg in 10 mL	Injection	ELFABRIO		C18929 C18930 C19015 C19045		See Schedule 2	See Schedule 2
Pegvisomant	Injection set containing powder for injection 10 mg, 30 and diluent, 30	Injection	Somavert		C19071 C19122		See Schedule 2	See Schedule 2
Pegvisomant	Injection set containing powder for injection 15 mg, 30 and diluent, 30	Injection	Somavert		C19071 C19122		See Schedule 2	See Schedule 2
Pegvisomant	Injection set containing powder for injection 20 mg, 1 and diluent, 1	Injection	Somavert		C19071		See Schedule 2	See Schedule 2
Pegvisomant	Injection set containing powder for injection 20 mg, 30 and diluent, 30	Injection	Somavert		C19071 C19122		See Schedule 2	See Schedule 2
Plerixafor	Injection 24 mg in 1.2 mL	Injection	Plerixafor ARX		C4549 C9329		1	1
Plerixafor	Injection 24 mg in 1.2 mL	Injection	PLERIXAFOR EUGIA		C4549 C9329		1	1
Pomalidomide	Capsule 1 mg	Oral	Pomalidomide Sandoz		C13755 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 1 mg	Oral	Pomolide		C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 2 mg	Oral	Pomalidomide Sandoz		C13755 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 2 mg	Oral	Pomolide		C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 3 mg	Oral	Pomalidomide Sandoz		C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 3 mg	Oral	Pomolide		C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 4 mg	Oral	Pomalidomide Sandoz		C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Pomalidomide	Capsule 4 mg	Oral	Pomolide		C13755 C13757 C13768 C19229		See Schedule 2	See Schedule 2
Raltegravir	Tablet 400 mg (as potassium)	Oral	Isentress	NP	C4454 C4512		120	5
Raltegravir	Tablet 600 mg (as potassium)	Oral	Isentress HD	NP	C4454 C4512		120	5
Ravulizumab	Solution concentrate for I.V. infusion 1,100 mg in 11 mL	Injection	Ultomiris		C14748 C16368 C17055 C17605 C17606 C17609 C17610 C17629 C17630 C17631 C18131 C18132 C18133 C18134 C18135 C18137 C18153 C18155 C18237 C18238 C18260 C18262 C18283 C18350 C18423 C19240		See Schedule 2	See Schedule 2
Ravulizumab	Solution concentrate for I.V. infusion 300 mg in 3 mL	Injection	Ultomiris		C14748 C16368 C17055 C17605 C17606 C17609 C17610 C17629 C17630 C17631 C18131 C18132 C18133 C18134 C18135 C18137 C18153 C18155 C18237 C18238 C18260 C18262 C18283 C18350 C18423 C19240		See Schedule 2	See Schedule 2
Rifabutin	Capsule 150 mg	Oral	Mycobutin	NP	C6350 C6356 C9560 C9622		120	5
Rilpivirine	Tablet 25 mg (as hydrochloride)	Oral	Edurant	NP	C4454 C4512		60	5
Riociguat	Tablet 500 micrograms	Oral	Adempas		C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
Riociguat	Tablet 1 mg	Oral	Adempas		C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
Riociguat	Tablet 1.5 mg	Oral	Adempas		C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
Riociguat	Tablet 2 mg	Oral	Adempas		C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
Riociguat	Tablet 2.5 mg	Oral	Adempas		C13502 C13514 C15271 C15272 C18200 C18215		See Schedule 2	See Schedule 2
Risdiplam	Powder for oral solution 750 micrograms per mL, 80 mL	Oral	Evrysdi		C14392 C14420 C15095 C15986 C18087 C18090 C18118 C18197 C18356 C18357		See Schedule 2	See Schedule 2
Risdiplam	Tablet 5 mg	Oral	Evrysdi		C14420 C18225 C18306 C18307 C18308 C18369 C18479		See Schedule 2	See Schedule 2
Ritonavir	Tablet 100 mg	Oral	Norvir	NP	C4454 C4512		720	5
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Riximyo				6	0
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Ruxience				6	0
Rituximab	Solution for I.V. infusion 100 mg in 10 mL	Injection	Truxima				6	0
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Riximyo				2	1
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Ruxience				2	1
Rituximab	Solution for I.V. infusion 500 mg in 50 mL	Injection	Truxima				2	1
Romiplostim	Powder for injection 375 micrograms	Injection	Nplate		C13396 C14099 C14149 C18405		See Schedule 2	See Schedule 2
Romiplostim	Powder for injection 625 micrograms	Injection	Nplate		C13396 C14099 C14149 C18405		See Schedule 2	See Schedule 2
Rozanolixizumab	Solution for subcutaneous infusion 280 mg in 2 mL (140 mg per mL)	Injection	Rystiggo		C18129 C18232 C18319 C18378 C18789		See Schedule 2	See Schedule 2
Ruxolitinib	Tablet 5 mg	Oral	Jakavi	NP	C19098 C19147	P19098 P19147	56	5
Ruxolitinib	Tablet 5 mg	Oral	Jakavi		C13907 C13911	P13907 P13911	56	0
Ruxolitinib	Tablet 10 mg	Oral	Jakavi	NP	C19098 C19147	P19098 P19147	56	5
Ruxolitinib	Tablet 10 mg	Oral	Jakavi		C13907 C13911	P13907 P13911	56	0
Selexipag	Tablet 200 micrograms	Oral	Uptravi		C11193 C11195 C11261		See Schedule 2	See Schedule 2
Selexipag	Tablet 400 micrograms	Oral	Uptravi		C11193 C11195		See Schedule 2	See Schedule 2
Selexipag	Tablet 600 micrograms	Oral	Uptravi		C11193 C11195		See Schedule 2	See Schedule 2
Selexipag	Tablet 800 micrograms	Oral	Uptravi		C11193 C11195 C11261		See Schedule 2	See Schedule 2
Selexipag	Tablet 1 mg	Oral	Uptravi		C11193 C11195		See Schedule 2	See Schedule 2
Selexipag	Tablet 1.2 mg	Oral	Uptravi		C11193 C11195		See Schedule 2	See Schedule 2
Selexipag	Tablet 1.4 mg	Oral	Uptravi		C11193 C11195		See Schedule 2	See Schedule 2
Selexipag	Tablet 1.6 mg	Oral	Uptravi		C11193 C11195		See Schedule 2	See Schedule 2
Selinexor	Tablet 20 mg	Oral	Xpovio		C14021 C14045	P14021 P14045	16	2
Selinexor	Tablet 20 mg	Oral	Xpovio		C14023 C14024	P14023 P14024	20	2
Selinexor	Tablet 20 mg	Oral	Xpovio		C14031 C14039	P14031 P14039	32	2
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	ARX-SEVELAMER		C5530 C9762		360	5
Sevelamer	Tablet containing sevelamer carbonate 800 mg	Oral	Sevelamer Lupin		C5530 C9762		360	5
Sevelamer	Tablet containing sevelamer hydrochloride 800 mg	Oral	Renagel		C5530 C9762		360	5
Sevelamer	Tablet containing sevelamer hydrochloride 800 mg	Oral	Sevelamer Waymade		C5530 C9762		360	5
Sildenafil	Tablet 20 mg (as citrate)	Oral	SILDATIO PHT		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Sildenafil	Tablet 20 mg (as citrate)	Oral	Sildenafil PHT APOTEX		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Sildenafil	Tablet 20 mg (as citrate)	Oral	SILDENAFIL PHT ARX		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Sildenafil	Tablet 20 mg (as citrate)	Oral	Sildenafil Sandoz PHT 20		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Siltuximab	Powder for injection 100 mg	Injection	Sylvant		C12585 C12594		2	4
Siltuximab	Powder for injection 400 mg	Injection	Sylvant		C12585 C12594		2	4
Sirolimus	Oral solution 1 mg per mL, 60 mL	Oral	Rapamune	NP	C19365 C19370		2	5
Sirolimus	Tablet 0.5 mg	Oral	Rapamune	NP	C19365 C19370		200	5
Sirolimus	Tablet 1 mg	Oral	Rapamune	NP	C19365 C19370		200	5
Sirolimus	Tablet 2 mg	Oral	Rapamune	NP	C19365 C19370		200	5
Sofosbuvir with velpatasvir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir	Oral	Epclusa	NP	C5969		28	2
Sofosbuvir with velpatasvir and voxilaprevir	Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir and 100 mg voxilaprevir	Oral	Vosevi	NP	C10248		28	2
Sucroferric oxyhydroxide	Tablet, chewable, 2.5 g (equivalent to 500 mg iron)	Oral	Velphoro		C5530 C9762		180	5
Tacrolimus	Capsule 0.5 mg	Oral	Pacrolim	NP	C19314 C19315		200	5
Tacrolimus	Capsule 0.5 mg	Oral	Pharmacor Tacrolimus 0.5	NP	C19314 C19315		200	5
Tacrolimus	Capsule 0.5 mg	Oral	Prograf	NP	C19314 C19315		200	5
Tacrolimus	Capsule 0.5 mg	Oral	Tacrograf	NP	C19314 C19315		200	5
Tacrolimus	Capsule 0.5 mg	Oral	Tacrolimus Sandoz	NP	C19314 C19315		200	5
Tacrolimus	Capsule 0.5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	NP	C19314 C19315		60	5
Tacrolimus	Capsule 0.5 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	NP	C19314 C19315		60	5
Tacrolimus	Capsule 0.75 mg	Oral	Tacrolimus Sandoz	NP	C19314 C19315		200	5
Tacrolimus	Capsule 1 mg	Oral	Pacrolim	NP	C19314 C19315		200	5
Tacrolimus	Capsule 1 mg	Oral	Pharmacor Tacrolimus 1	NP	C19314 C19315		200	5
Tacrolimus	Capsule 1 mg	Oral	Prograf	NP	C19314 C19315		200	5
Tacrolimus	Capsule 1 mg	Oral	Tacrograf	NP	C19314 C19315		200	5
Tacrolimus	Capsule 1 mg	Oral	Tacrolimus Sandoz	NP	C19314 C19315		200	5
Tacrolimus	Capsule 1 mg (once daily prolonged release)	Oral	ADVAGRAF XL	NP	C19314 C19315		120	5
Tacrolimus	Capsule 1 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	NP	C19314 C19315		120	5
Tacrolimus	Capsule 2 mg	Oral	Tacrolimus Sandoz	NP	C19314 C19315		200	5
Tacrolimus	Capsule 3 mg (once daily prolonged release)	Oral	ADVAGRAF XL	NP	C19314 C19315		100	3
Tacrolimus	Capsule 3 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	NP	C19314 C19315		100	3
Tacrolimus	Capsule 5 mg	Oral	Pharmacor Tacrolimus 5	NP	C19314 C19315		100	5
Tacrolimus	Capsule 5 mg	Oral	Prograf	NP	C19314 C19315		100	5
Tacrolimus	Capsule 5 mg	Oral	Tacrograf	NP	C19314 C19315		100	5
Tacrolimus	Capsule 5 mg	Oral	Tacrolimus Sandoz	NP	C19314 C19315		100	5
Tacrolimus	Capsule 5 mg (once daily prolonged release)	Oral	ADVAGRAF XL	NP	C19314 C19315		60	5
Tacrolimus	Capsule 5 mg (once daily prolonged release)	Oral	Tacrolimus XR Sandoz	NP	C19314 C19315		60	5
Tadalafil	Tablet 20 mg	Oral	Adcirca		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Tadalafil	Tablet 20 mg	Oral	Tadalca		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Tadalafil	Tablet 20 mg	Oral	TADALIS 20		C11229 C13569 C13572 C18748 C18749 C18782 C18854 C18876		See Schedule 2	See Schedule 2
Tadalafil	Tablet 20 mg	Oral	Tadalis 20		C15463 C15495 C15525 C18780 C18824 C18852 C18872 C18884		See Schedule 2	See Schedule 2
Teduglutide	Powder for injection 5 mg with diluent	Injection	Revestive		C11999 C18198 C18986		See Schedule 2	See Schedule 2
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	TENOFOVIR ARX	NP	C10362	P10362	60	2
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	TENOFOVIR ARX	NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Tenofovir Sandoz	NP	C10362	P10362	60	2
Tenofovir	Tablet containing tenofovir disoproxil fumarate 300 mg	Oral	Tenofovir Sandoz	NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5
Tenofovir	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Viatris	NP	C10362	P10362	60	2
Tenofovir	Tablet containing tenofovir disoproxil maleate 300 mg	Oral	Tenofovir Disoproxil Viatris	NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5
Tenofovir	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	NP	C10362	P10362	60	2
Tenofovir	Tablet containing tenofovir disoproxil phosphate 291 mg	Oral	Tenofovir GH	NP	C6980 C6982 C6983 C6984 C6992 C6998	P6980 P6982 P6983 P6984 P6992 P6998	60	5
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	NP	C4470 C4522		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	CIPLA TENOFOVIR + EMTRICITABINE 300/200	NP	C6985 C6986		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 APX	NP	C6985 C6986		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	TENOFOVIR/EMTRICITABINE 300/200 ARX	NP	C6985 C6986		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz Pharma 300/200	NP	C6985 C6986		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg	Oral	Tenofovir Disoproxil Emtricitabine Viatris 300/200	NP	C6985 C6986		60	5
Tenofovir with emtricitabine	Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg	Oral	Tenofovir/Emtricitabine Sandoz 301/200	NP	C6985 C6986		60	5
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)	NP	C4470 C4522		60	5
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	NP	C4470 C4522		60	5
Teprotumumab	Powder for I.V. infusion 500 mg	Injection	Tepezza		C19494	P19494	3	0
Teprotumumab	Powder for I.V. infusion 500 mg	Injection	Tepezza		C19461 C19524	P19461 P19524	6	6
Tezacaftor with ivacaftor and ivacaftor	Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg	Oral	Symdeko	NP	C19416 C19484		See Schedule 2	See Schedule 2
Tezacaftor with ivacaftor and ivacaftor	Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg	Oral	Symdeko		C17844 C17968		See Schedule 2	See Schedule 2
Tezepelumab	Solution for injection 210 mg in 1.91 mL single dose pre-filled pen (110 mg per mL)	Injection	Tezspire		C19093 C19094 C19095 C19199		See Schedule 2	See Schedule 2
Thalidomide	Capsule 50 mg	Oral	Thalomid		C5914 C9290		112	0
Thalidomide	Capsule 100 mg	Oral	Thalomid		C5914 C9290		56	0
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Actemra		C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18945 C18946 C18947		See Schedule 2	See Schedule 2
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Avtozma		C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18933 C18934 C18936 C18938 C18945 C18946 C18947 C18978 C18980 C19000 C19024 C19046		See Schedule 2	See Schedule 2
Tocilizumab	Concentrate for injection 80 mg in 4 mL	Injection	Avtozma		C18939 C18941	P18939 P18941	2	5
Tocilizumab	Concentrate for injection 200 mg in 10 mL	Injection	Actemra		C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18945 C18946 C18947		See Schedule 2	See Schedule 2
Tocilizumab	Concentrate for injection 200 mg in 10 mL	Injection	Avtozma		C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18933 C18934 C18936 C18938 C18945 C18946 C18947 C18978 C18980 C19000 C19024 C19046		See Schedule 2	See Schedule 2
Tocilizumab	Concentrate for injection 200 mg in 10 mL	Injection	Avtozma		C18939 C18941	P18939 P18941	4	5
Tocilizumab	Concentrate for injection 400 mg in 20 mL	Injection	Actemra		C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18945 C18946 C18947		See Schedule 2	See Schedule 2
Tocilizumab	Concentrate for injection 400 mg in 20 mL	Injection	Avtozma		C9386 C10570 C12120 C14085 C14091 C14093 C14148 C14179 C14485 C14488 C14507 C14621 C17707 C17712 C17713 C17714 C17729 C18172 C18174 C18177 C18180 C18275 C18276 C18280 C18282 C18346 C18348 C18933 C18934 C18936 C18938 C18945 C18946 C18947 C18978 C18980 C19000 C19024 C19046		See Schedule 2	See Schedule 2
Tocilizumab	Concentrate for injection 400 mg in 20 mL	Injection	Avtozma		C18939 C18941	P18939 P18941	4	5
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody		C19261	P19261	1	2
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody		C19237 C19253	P19237 P19253	1	5
Tofersen	Solution for intrathecal injection 100 mg in 15 mL	Injection	Qalsody		C19231 C19243	P19231 P19243	1	6
Ublituximab	Solution concentrate for I.V. infusion 150 mg in 6 mL	Injection	Briumvi		C7386 C9635	P7386 P9635	3	0
Ublituximab	Solution concentrate for I.V. infusion 150 mg in 6 mL	Injection	Briumvi		C7699 C9523	P7699 P9523	4	0
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Stelara		C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172		See Schedule 2	See Schedule 2
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Steqeyma		C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172		See Schedule 2	See Schedule 2
Ustekinumab	Solution for I.V. infusion 130 mg in 26 mL	Injection	Wezlana		C16866 C16939 C16958 C18785 C18825 C18856 C19149 C19171 C19172		See Schedule 2	See Schedule 2
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	APX-Valaciclovir		C5975 C9267		500	2
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valaciclovir RBX		C5975 C9267		500	2
Valaciclovir	Tablet 500 mg (as hydrochloride)	Oral	Valtrex		C5975 C9267		500	2
Valganciclovir	Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL	Oral	Valcyte	NP	C4980 C19374 C19463 C19505 C19515		11	5
Valganciclovir	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Sandoz	NP	C4980 C19374 C19463 C19505 C19515		120	5
Valganciclovir	Tablet 450 mg (as hydrochloride)	Oral	Valganciclovir Viatris	NP	C4980 C19374 C19463 C19505 C19515		120	5
Vanzacaftor with tezacaftor and with deutivacaftor	Tablet containing 4 mg vanzacaftor (as calcium) with 20 mg tezacaftor and with 50 mg deutivacaftor	Oral	Alyftrek		C17769 C17932		See Schedule 2	See Schedule 2
Vanzacaftor with tezacaftor and with deutivacaftor	Tablet containing 10 mg vanzacaftor (as calcium) with 50 mg tezacaftor and with 125 mg deutivacaftor	Oral	Alyftrek		C17769 C17932		See Schedule 2	See Schedule 2
Vedolizumab	Powder for injection 300 mg	Injection	Entyvio		C15844 C15909 C15910 C15923 C15933 C18759 C18760 C18805 C18806 C18807 C18863 C18906 C19112 C19113 C19155 C19210		See Schedule 2	See Schedule 2
Vutrisiran	Injection 25 mg (as sodium) in 0.5 mL pre-filled syringe	Injection	Amvuttra		C16434 C16446		See Schedule 2	See Schedule 2
Zidovudine	Capsule 100 mg	Oral	Retrovir	NP	C4454 C4512		400	5
Zidovudine	Capsule 250 mg	Oral	Retrovir	NP	C4454 C4512		240	5
Zidovudine	Syrup 10 mg per mL, 200 mL	Oral	Retrovir	NP	C4454 C4512		15	5
Zilucoplan	Solution for injection 16.6 mg in 0.416 mL (as tetrasodium) pre-filled syringe	Injection	Zilbrysq		C18128 C18129 C18232 C18319 C18378		See Schedule 2	See Schedule 2
Zilucoplan	Solution for injection 23 mg in 0.574 mL (as tetrasodium) pre-filled syringe	Injection	Zilbrysq		C18128 C18129 C18232 C18319 C18378		See Schedule 2	See Schedule 2
Zilucoplan	Solution for injection 32.4 mg in 0.810 mL (as tetrasodium) pre-filled syringe	Injection	Zilbrysq		C18128 C18129 C18232 C18319 C18378		See Schedule 2	See Schedule 2
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	APO-Zoledronic Acid		C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328		1	11
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	DEZTRON	NP	C19289 C19428	P19289 P19428	1	0
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	DEZTRON		C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronate-DRLA 4	NP	C19289 C19428	P19289 P19428	1	0
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronate-DRLA 4		C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronic Acid Accord	NP	C19289 C19428	P19289 P19428	1	0
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zoledronic Acid Accord		C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328	P5605 P5703 P5704 P5735 P9268 P9304 P9317 P9328	1	11
Zoledronic acid	Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL	Injection	Zometa		C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328		1	11

[2] Schedule 2, entry for Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

(a) omit from the column headed “Circumstances”: C17770

(b) omit from the column headed “Circumstances”: C17937

(c) omit from the column headed “Circumstances”: C17971

(d) insert in numerical order in the column headed “Circumstances”: C19433 C19435 C19473

[3] Schedule 2, entry for Ivacaftor [Maximum quantity: 1 pack; Maximum repeats: Sufficient for 24 weeks of treatment]

(a) omit from the column headed “Circumstances”: C16845 C16876

(b) insert in numerical order in the column headed “Circumstances”: C19296 C19349

[4] Schedule 2, entry for Lumacaftor with ivacaftor

(a) omit from the column headed “Circumstances”: C17763

(b) omit from the column headed “Circumstances”: C17842 C17933

(c) insert in numerical order in the column headed “Circumstances”: C19357 C19415 C19499

[5] Schedule 2, entry for Mepolizumab [Maximum quantity: 1; Maximum repeats: 5]

(a) omit from the column headed “Circumstances”: C19200

(b) insert in numerical order in the column headed “Circumstances”: C19465

[6] Schedule 2, entry for Midostaurin

(a) omit from the column headed “Circumstances”: C11699

(b) insert in numerical order in the column headed “Circumstances”: C19376

[7] Schedule 2, entry for Onasemnogene abeparvovec

omit from the column headed “Circumstances”: C15989 C16045 C18211 C18213 substitute: C19297 C19299 C19302 C19304

[8] Schedule 2, entry for Tezacaftor with ivacaftor and ivacaftor

(a) omit from the column headed “Circumstances”: C17935

(b) omit from the column headed “Circumstances”: C17969

(c) insert in numerical order in the column headed “Circumstances”: C19416 C19484

[9] Schedule 2, entry for Tocilizumab [Maximum quantity: 2 infusions; Maximum repeats: 5]

omit from the column headed “Circumstances”: C18939 C18941

[10] Schedule 3, entry for Ciclosporin

(a) omit entry for Circumstances Code “C6628”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C6631”: Ciclosporin

(c) omit entry for Circumstances Code “C6638”

(d) omit entry for Circumstances Code “C6643”

(e) omit entry for Circumstances Code “C9742”

(f) omit entry for Circumstances Code “C9764”

(g) omit entry for Circumstances Code “C9831”

(h) insert in numerical order after existing text:

	C19414		Management of transplant rejectionManagement (initiation, stabilisation and review of therapy)Patient must have had an organ or tissue transplantation, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19414
	C19423		Severe active rheumatoid arthritisManagement (initiation, stabilisation and review of therapy)The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); ORThe condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist.	Compliance with Authority Required procedures - Streamlined Authority Code 19423
	C19424		Management of transplant rejectionThe treatment must be used by organ or tissue transplant recipients.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19424
	C19482		Severe active rheumatoid arthritisManagement (initiation, stabilisation and review of therapy)The condition must have been ineffective to prior treatment with classical slow-acting anti-rheumatic agents (including methotrexate); ORThe condition must be considered inappropriate for treatment with slow-acting anti-rheumatic agents (including methotrexate).Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist.	Compliance with Authority Required procedures - Streamlined Authority Code 19482
	C19503		Management of transplant rejectionThe treatment must be used by organ or tissue transplant recipients.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19503
	C19511		Management of transplant rejectionManagement (initiation, stabilisation and review of therapy)Patient must have had an organ or tissue transplantation, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19511

[11] Schedule 3, entry for Clozapine

(a) omit entry for Circumstances Code “C4998”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C5015”: Clozapine

(c) insert in numerical order after existing text:

	C19290		SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.	Compliance with Authority Required procedures - Streamlined Authority Code 19290
	C19429		SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.	Compliance with Authority Required procedures - Streamlined Authority Code 19429
	C19467		SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.	Compliance with Authority Required procedures - Streamlined Authority Code 19467
	C19469		SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.	Compliance with Authority Required procedures - Streamlined Authority Code 19469
	C19470		SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.	Compliance with Authority Required procedures - Streamlined Authority Code 19470
	C19507		SchizophreniaContinuing treatmentMust be treated by a psychiatrist; ORMust be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with the treating psychiatrist, (ii) the prescription continues existing therapy with this medicine.Patient must have previously received PBS-subsidised therapy with this drug for this condition, ANDPatient must have completed at least 18 weeks therapy, ANDPatient must be on a clozapine dosage considered stable by a treating psychiatrist, ANDThe treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.	Compliance with Authority Required procedures - Streamlined Authority Code 19507

[12] Schedule 3, entry for Deferasirox

substitute:

Deferasirox	C19286	P19286	Chronic iron overloadInitial treatmentPatient must be red blood cell transfusion dependent, ANDPatient must have a serum ferritin level of greater than 1000 microgram/L, ANDPatient must have a malignant disorder of haemopoiesis, ANDPatient must have a median life expectancy exceeding five years.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
	C19311	P19311	Chronic iron overloadContinuing treatmentPatient must be red blood cell transfusion dependent, ANDPatient must have a malignant disorder of haemopoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.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 19311
	C19312	P19312	Chronic iron overloadInitial treatmentPatient must not be transfusion dependent, ANDThe condition must be thalassaemia.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
	C19318	P19318	Chronic iron overloadInitial treatmentPatient must be transfusion dependent, ANDPatient must not have a malignant disorder of erythropoiesis.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
	C19375	P19375	Chronic iron overloadContinuing treatmentPatient must be red blood cell transfusion dependent, ANDPatient must have a malignant disorder of haemopoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.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 19375
	C19384	P19384	Chronic iron overloadContinuing treatmentPatient must not be transfusion dependent, ANDThe condition must be thalassaemia, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.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 19384
	C19386	P19386	Chronic iron overloadContinuing treatmentPatient must be transfusion dependent, ANDPatient must not have a malignant disorder of erythropoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.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 19386
	C19439	P19439	Chronic iron overloadContinuing treatmentPatient must be transfusion dependent, ANDPatient must not have a malignant disorder of erythropoiesis, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.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 19439
	C19506	P19506	Chronic iron overloadContinuing treatmentPatient must not be transfusion dependent, ANDThe condition must be thalassaemia, ANDPatient must have previously received PBS-subsidised therapy with deferasirox for this condition.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 19506

[13] Schedule 3 entry for Deferiprone

substitute:

Deferiprone	C19310		Iron overloadPatient must have thalassaemia major, ANDPatient must be unable to take desferrioxamine therapy.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 19310
	C19436		Iron overloadPatient must have thalassaemia major, ANDPatient must be one in whom desferrioxamine therapy has proven ineffective.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 19436
	C19437		Iron overloadPatient must have thalassaemia major, ANDPatient must be unable to take desferrioxamine therapy.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 19437
	C19492		Iron overloadPatient must have thalassaemia major, ANDPatient must be one in whom desferrioxamine therapy has proven ineffective.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 19492

[14] Schedule 3, entry for Desferrioxamine

substitute:

Desferrioxamine	C19476		Disorders of erythropoiesisThe condition must be associated with treatment-related chronic iron overload.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 19476
	C19477		Disorders of erythropoiesisThe condition must be associated with treatment-related chronic iron overload.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 19477

[15] Schedule 3, entry for Dornase alfa

substitute:

Dornase alfa	C19378		Cystic fibrosisContinuing treatmentPatient must have initiated treatment with dornase alfa at an age of less than 5 years, ANDPatient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.Patient must be 5 years of age or older.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19378
	C19432		Cystic fibrosisContinuing treatmentPatient must have initiated treatment with dornase alfa at an age of less than 5 years, ANDPatient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.Patient must be 5 years of age or older.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19432
	C19546		Cystic fibrosisPatient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; ORPatient must have significant bronchiectasis on chest high resolution computed tomography scan; ORPatient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; ORPatient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy, ANDPatient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must be less than 5 years of age.Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.	Compliance with Authority Required procedures - Streamlined Authority Code 19546
	C19554		Cystic fibrosisPatient must be 5 years of age or older.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19554
	C19559		Cystic fibrosisPatient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; ORPatient must have significant bronchiectasis on chest high resolution computed tomography scan; ORPatient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; ORPatient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy, ANDPatient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Patient must be less than 5 years of age.Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals.	Compliance with Authority Required procedures - Streamlined Authority Code 19559
	C19563		Cystic fibrosisPatient must be 5 years of age or older.Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19563

[16] Schedule 3, entry for Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

(a) omit entry for Circumstances Code “C17770”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C17772”: Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor

(c) omit entry for Circumstances Code “C17937”

(d) omit entry for Circumstances Code “C17971”

(e) insert in numerical order after existing text:

	C19433		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be aged between 2 and 11 years inclusive.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.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
	C19435		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be at least 6 years of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.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
	C19473		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be 2 to 5 years of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.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

[17] Schedule 3, entry for Everolimus

substitute:

Everolimus	C19365		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19365
	C19366		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19366
	C19370		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19370
	C19459		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19459

[18] Schedule 3, entry for Filgrastim

substitute:

Filgrastim	C19325		Mobilisation of peripheral blood progenitor cellsThe treatment must be in a normal volunteer for use in allogeneic transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19325
	C19326		Severe congenital neutropeniaPatient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, ANDPatient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19326
	C19327		Chronic cyclical neutropeniaPatient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19327
	C19330		Chronic cyclical neutropeniaPatient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19330
	C19332		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19332
	C19333		Mobilisation of peripheral blood progenitor cellsThe treatment must be in a normal volunteer for use in allogeneic transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19333
	C19334		Assisting autologous peripheral blood progenitor cell transplantationThe treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19334
	C19339		Mobilisation of peripheral blood progenitor cellsThe treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19339
	C19340		Assisting autologous peripheral blood progenitor cell transplantationThe treatment must be following marrow-ablative chemotherapy for non-myeloid malignancy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19340
	C19392		Mobilisation of peripheral blood progenitor cellsThe treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non-myeloid malignancy who has had myeloablative or myelosuppressive therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19392
	C19395		Severe congenital neutropeniaPatient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart, ANDPatient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19395
	C19397		Severe chronic neutropeniaPatient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; ORPatient must have neutrophil dysfunction, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19397
	C19398		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19398
	C19399		Assisting bone marrow transplantationPatient must be receiving marrow-ablative chemotherapy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19399
	C19400		Severe chronic neutropeniaPatient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; ORPatient must have neutrophil dysfunction, ANDPatient must have experienced a life-threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; ORPatient must have had at least 3 recurrent clinically significant infections in the previous 12 months.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19400
	C19403		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19403
	C19443		Assisting bone marrow transplantationPatient must be receiving marrow-ablative chemotherapy prior to the transplantation.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19443
	C19447		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19447

[19] Schedule 3, entry for Ivacaftor

(a) omit entry for Circumstances Code “C16845”

(b) omit entry for Circumstances Code “C16876”

(c) insert in numerical order after existing text:

	C19296		Cystic fibrosisContinuing treatment (non-gating mutations)Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application, ANDThe treatment must be given concomitantly with standard therapy for this condition, ANDPatient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit.Must be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis.Patient must be aged 4 months or older.Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.Ivacaftor is not PBS-subsidised for this condition as a sole therapy.Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wortModerate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillinWeak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.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
	C19349		Cystic fibrosisContinuing treatment (gating mutations)Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition, ANDPatient must not receive more than 24 weeks of treatment under this restriction per authority application, ANDThe treatment must be given concomitantly with standard therapy for this condition, ANDPatient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit.Must be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis.Patient must be aged 4 months or older.Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks.Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks.Ivacaftor is not PBS-subsidised for this condition as a sole therapy.Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wortModerate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillinWeak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.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

[20] Schedule 3, entry for Lanreotide

(a) omit entry for Circumstances Code “C4575”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C7025”: Lanreotide

(c) omit entry for Circumstances Code “C9260”

(d) omit entry for Circumstances Code “C15955”

(e) omit entry for Circumstances Code “C17635”

(f) omit entry for Circumstances Code “C17637”

(g) omit entry for Circumstances Code “C17696”

(h) insert in numerical order after existing text:

	C19534		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.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 specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.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 19534
	C19542		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.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 specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.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 19542
	C19547		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.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 specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.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 19547
	C19548		Functional carcinoid tumourContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.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 specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19548
	C19552		Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.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 specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19552
	C19560		Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.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 specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19560

[21] Schedule 3, entry for Lumacaftor with ivacaftor

(a) omit entry for Circumstances Code “C17763”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C17765”: Lumacaftor with ivacaftor

(c) omit entry for Circumstances Code “C17842”

(d) omit entry for Circumstances Code “C17933”

(e) insert in numerical order after existing text:

	C19357		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be at least 1 year of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; AND(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; AND(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C19415		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be aged between 6 and 11 years inclusive.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; AND(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; AND(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C19499		Cystic fibrosisContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.Patient must be at least 12 years of age.This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.The authority application must be in writing and must include:(1) details of the proposed prescription; AND(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; AND(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures

[22] Schedule 3, entry for Mannitol

substitute:

Mannitol	C19292		Cystic fibrosisThe treatment must be as monotherapy, ANDPatient must be intolerant or inadequately responsive to dornase alfa.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; 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 respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19292
	C19379		Cystic fibrosisThe treatment must be in combination with dornase alfa, ANDPatient must be inadequately responsive to dornase alfa, ANDPatient must have trialled hypertonic saline for this condition.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; 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 respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19379
	C19380		Cystic fibrosisThe treatment must be in combination with dornase alfa, ANDPatient must be inadequately responsive to dornase alfa, ANDPatient must have trialled hypertonic saline for this condition.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; 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 respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19380
	C19472		Cystic fibrosisThe treatment must be as monotherapy, ANDPatient must be intolerant or inadequately responsive to dornase alfa.Patient must be 6 years of age or older.Must be treated in a cystic fibrosis clinic/centre where there are specialist respiratory physicians with expertise in the management of cystic fibrosis; ORMust be treated by a specialist physician in consultation with the above mentioned specialist medical practitioner(s); ORMust be treated by a paediatrician in consultation with a specialist respiratory physician; 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 respiratory physician with expertise in cystic fibrosis.Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.To be eligible for continued PBS-subsidised treatment with this drug following 3 months of initial treatment:(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND(2) the patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.	Compliance with Authority Required procedures - Streamlined Authority Code 19472

[23] Schedule 3, entry for Mepolizumab

(a) omit entry for Circumstances Code “C19200”

(b) insert in numerical order after existing text:

C19465

Uncontrolled chronic obstructive pulmonary disease (COPD)Continuing treatmentPatient must have received PBS-subsidised treatment with this biological medicine for this condition, ANDPatient must have both, achieved and sustained an adequate response to this drug, compared to the baseline levels provided with the initial PBS authority application, ANDThe treatment must be in combination with all of: (i) LAMA; (ii) LABA; (iii) ICS in an optimised triple inhaler therapy, 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) respiratory physician; (ii) general physician experienced in the management of patients with this condition.Assessment of adequate response for continuing treatment:For patients with severe exacerbations at baseline, adequate response is defined as:Maintenance (i.e. no change) or a reduction in the number of severe exacerbations compared with baseline; ANDNo increase in the total number of moderate and severe exacerbations.For patients with moderate exacerbations only at baseline, adequate response is defined as:Maintenance (i.e. no change) or a reduction in the number of moderate exacerbations compared with baseline; ANDNo occurrence of a severe exacerbation.The following must be provided in each continuing PBS authority application and be documented in the patient's medical records:details of the current number and severity of exacerbations compared to baseline levels provided in the initial authority application of this treatment cycle including:(i) number of moderate exacerbations requiring treatment with systemic corticosteroids; and/OR(ii) number of moderate exacerbations requiring treatment with antibiotics; AND(iii) number of severe exacerbation(s) which required hospitalisation.

Compliance with Authority Required procedures

[24] Schedule 3, entry for Midostaurin

(a) omit entry for Circumstances Code “C11699”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C13001”: Midostaurin

(c) insert in numerical order after existing text:

C19376

Acute Myeloid LeukaemiaMaintenance therapy - Continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial maintenance treatment restriction, ANDPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition, ANDPatient must not be undergoing or have undergone a stem cell transplant.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.A maximum of 9 cycles will be authorised under this restriction in a lifetime.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, 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:Leukaemic cells in the CSF;Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;Extramedullary leukaemia.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

[25] Schedule 3, entry for Mycophenolic acid

(a) omit entry for Circumstances Code “C4084”

(b) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C4095”: Mycophenolic Acid

(c) omit entry for Circumstances Code “C5554”

(d) omit entry for Circumstances Code “C5600”

(e) omit entry for Circumstances Code “C5653”

(f) omit entry for Circumstances Code “C5795”

(g) omit entry for Circumstances Code “C9689”

(h) omit entry for Circumstances Code “C9690”

(i) omit entry for Circumstances Code “C9691”

(j) omit entry for Circumstances Code “C9692”

(k) omit entry for Circumstances Code “C9693”

(l) insert in numerical order after existing text:

	C19362		Prophylaxis of renal allograft rejectionManagementThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19362
	C19365		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19365
	C19366		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19366
	C19370		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19370
	C19459		Management of cardiac allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19459
	C19485		Prophylaxis of renal allograft rejectionManagementThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19485

[26] Schedule 3, entry for Octreotide

(a) omit entry for Circumstances Code “C5901”

(b) omit entry for Circumstances Code “C5906”

(c) omit entry for Circumstances Code “C6369”

(d) omit entry for Circumstances Code “C6390”

(e) insert in the column headed “Listed Drug” for the entry for Circumstances Code “C8161”: Octreotide

(f) omit entry for Circumstances Code “C8198”

(g) omit entry for Circumstances Code “C8208”

(h) omit entry for Circumstances Code “C9232”

(i) omit entry for Circumstances Code “C9288”

(j) omit entry for Circumstances Code “C9289”

(k) omit entry for Circumstances Code “C9313”

(l) omit entry for Circumstances Code “C17634”

(m) omit entry for Circumstances Code “C17635”

(n) omit entry for Circumstances Code “C17637”

(o) insert in numerical order after existing text:

	C19321		Vasoactive intestinal peptide secreting tumour (VIPoma)The condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19321
	C19322		Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19322
	C19442		Functional carcinoid tumourThe condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19442
	C19479		Vasoactive intestinal peptide secreting tumour (VIPoma)The condition must be causing intractable symptoms, ANDPatient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, ANDPatient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19479
	C19533		Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19533
	C19538		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.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.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 19538
	C19539		Functional carcinoid tumourPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19539
	C19540		Functional carcinoid tumourPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19540
	C19543		Functional carcinoid tumourPatient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19543
	C19544		Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19544
	C19549		Vasoactive intestinal peptide secreting tumour (VIPoma)Patient must have achieved symptom control on octreotide immediate release injections, ANDThe treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.	Compliance with Authority Required procedures - Streamlined Authority Code 19549
	C19562		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.Must be treated by a specialist medical practitioner; ORMust be treated by a non-specialist medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.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 19562
	C19565		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.Must be treated by a medical practitioner where the prescription continues existing therapy with this medicine; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.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 19565

[27] Schedule 3, entry for Onasemnogene abeparvovec

substitute:

Onasemnogene abeparvovec	C19297		Spinal muscular atrophy (SMA)Use in a patient untreated with disease modifying therapies for this conditionThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene, ANDThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene, ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes, ANDThe treatment must be given concomitantly with best supportive care for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA, ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing, ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime, ANDPatient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.Patient must weigh 21 kg or less.Patient must be under 36 months 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).State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.	Compliance with Written Authority Required procedures
	C19299		Spinal muscular atrophy (SMA)Use in a patient untreated with disease modifying therapies for this conditionThe condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; ORThe condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene, ANDPatient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; ORThe condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene, ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes, ANDThe treatment must be given concomitantly with best supportive care for this condition.Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA, ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing, ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime, ANDPatient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.Patient must weigh 21 kg or less.Patient must have symptomatic Type I, II or IIIa SMA; ORPatient must have pre-symptomatic SMA with 1-2 copies of the SMN2 gene and are no older than 36 months 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).In the relevant PBS Authority Application form, specify the following:(i) the SMA type being treated: symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA;(ii) for Type I, II or IIIa SMA, the signs/symptoms that the patient has experienced, together with the patient's age at the onset of these signs/symptoms.State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.If the condition is pre-symptomatic SMA, confirm that there is genetic test finding that substantiates the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.Defined signs and symptoms of type I SMA are:i) Onset before 6 months of age; ANDii) Failure to meet or regression in ability to perform age-appropriate motor milestones; ORiii) Proximal weakness; ORiv) Hypotonia; ORv) Absence of deep tendon reflexes; ORvi) Failure to gain weight appropriate for age; ORvii) Any active chronic neurogenic changes; ORviii) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type II SMA are:i) Onset between 6 and 18 months; ANDii) Failure to meet or regression in ability to perform age-appropriate motor milestones; ORiii) Proximal weakness; ORiv) Weakness in trunk righting/derotation; ORv) Hypotonia; ORvi) Absence of deep tendon reflexes; ORvii) Failure to gain weight appropriate for age; ORviii) Any active chronic neurogenic changes; ORix) A compound muscle action potential below normative values for an age-matched child.Defined signs and symptoms of type IIIa SMA are:i) Onset between 18 months and 3 years of age; ANDii) Failure to meet or regression in ability to perform age-appropriate motor milestones; ORiii) Proximal weakness; ORiv) Hypotonia; ORv) Absence of deep tendon reflexes; ORvi) Failure to gain weight appropriate for age; ORvii) Any active chronic neurogenic changes; ORviii) A compound muscle action potential below normative values for an age-matched child.	Compliance with Written Authority Required procedures
	C19302		Spinal muscular atrophy (SMA)Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)The treatment must be given concomitantly with best supportive care for this condition, ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition prior to 36 months of age, ANDMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA, ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing, ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime, ANDPatient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.Patient must weigh 21 kg or less.Patient must have pre-symptomatic SMA with 3 copies of the SMN2 gene.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).Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene.State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.	Compliance with Written Authority Required procedures
	C19304		Spinal muscular atrophy (SMA)Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)The treatment must be given concomitantly with best supportive care for this condition, ANDThe treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition, ANDMust be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA, ANDMust be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing, ANDPatient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime, ANDPatient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.Patient must weigh 21 kg or less.Patient must have symptomatic Type I, II or IIIa SMA; ORPatient must have pre-symptomatic SMA with 1-2 copies of SMN2 gene where a disease-modifying therapy (DMT) was initiated prior to 36 months 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).Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.Confirm that a previous PBS authority application has been approved for one of the following:(i) Symptomatic Type I, II or IIIa SMA; OR(ii) Pre-symptomatic SMA with 1-2 copies of SMN2 gene.State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.	Compliance with Written Authority Required procedures

[28] Schedule 3, entry for Pegfilgrastim

substitute:

Pegfilgrastim	C19332		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19332
	C19403		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19403
	C19449		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must be at greater than 20% risk of developing febrile neutropenia; ORPatient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19449
	C19508		Chemotherapy-induced neutropeniaPatient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission, ANDPatient must have had a prior episode of febrile neutropenia; ORPatient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19508

[29] Schedule 3, entry for Sirolimus

substitute:

Sirolimus	C19365		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19365
	C19370		Management of renal allograft rejectionManagement (initiation, stabilisation and review of therapy)Patient must be receiving this drug for prophylaxis of renal allograft rejection, ANDThe treatment must be under the supervision and direction of a transplant unit, ANDMust be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19370

[30] Schedule 3, entry for Tacrolimus

substitute:

Tacrolimus	C19314		Management of rejection in patients following organ or tissue transplantationThe treatment must be under the supervision and direction of a transplant unit, ANDThe treatment must include initiation, stabilisation, and review of therapy as required.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19314
	C19315		Management of rejection in patients following organ or tissue transplantationThe treatment must be under the supervision and direction of a transplant unit, ANDThe treatment must include initiation, stabilisation, and review of therapy as required.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19315

[31] Schedule 3, after entry for Tenofovir with emtricitabine and efavirenz

insert:

Teprotumumab	C19461	P19461	Active moderate to severe thyroid eye diseaseContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a specialist medical practitioner experienced in the management of thyroid eye disease; or in consultation with a specialist medical practitioner experienced in the management of thyroid eye disease.After completing 8 doses in total of PBS-subsidised treatment with teprotumumab, a patient may be eligible for re-treatment through the initial treatment phase only, if a response to treatment was previously demonstrated.	Compliance with Authority Required procedures - Streamlined Authority Code 19461
	C19494	P19494	Active moderate to severe thyroid eye diseaseInitial treatmentPatient must not have previously received PBS-subsidised treatment with this drug for this condition; ORPatient must be both: (i) undergoing re-treatment with this drug for this condition; and (ii) have demonstrated response to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must have a clinical activity score (CAS) of at least three for the most severely affected eye, ANDPatient must have two or more of the following: (i) Proptosis at least 3 mm above normal for race and gender; (ii) Lid retraction of at least 2 mm; (iii) Moderate to severe soft-tissue involvement; (iv) Inconstant or constant diplopia.Patient must be at least 18 years of age.Must be treated by a specialist medical practitioner experienced in the treatment of thyroid eye disease.The following must be provided at the time of application and documented in the patient's medical records for the first prescription only:(1) Baseline clinical activity score (CAS); AND(2) Confirmation of the presence of thyroid eye disease.This includes evidence of two or more of the following:(i) Proptosis at least 3 mm above normal for race and gender;(ii) Lid retraction of at least 2 mm;(iii) Moderate to severe soft-tissue involvement;(iv) Inconstant or constant diplopia.After completing 8 doses in total of PBS-subsidised treatment with teprotumumab, a patient may be eligible for re-treatment through the initial treatment phase only, if a response to treatment was previously demonstrated.	Compliance with Authority Required procedures
	C19524	P19524	Active moderate to severe thyroid eye diseaseContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition.Must be treated by a specialist medical practitioner experienced in the management of thyroid eye disease; or in consultation with a specialist medical practitioner experienced in the management of thyroid eye disease.After completing 8 doses in total of PBS-subsidised treatment with teprotumumab, a patient may be eligible for re-treatment through the initial treatment phase only, if a response to treatment was previously demonstrated.	Compliance with Authority Required procedures - Streamlined Authority Code 19524

[32] Schedule 3, entry for Tezacaftor with ivacaftor and ivacaftor

(a) omit entry for Circumstances Code “C17935”

(b) omit entry for Circumstances Code “C17969”

(c) insert in numerical order after existing text:

	C19416		Cystic fibrosis - one residual function (RF) mutationContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be at least 12 years of age.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be in writing and must include:(1) details of the proposed prescription; AND(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; AND(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures
	C19484		Cystic fibrosis - homozygous for the F508del mutationContinuing treatmentMust be treated by a specialist respiratory physician with expertise in cystic fibrosis; 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 respiratory physician with expertise in cystic fibrosis, ANDMust be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.Patient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition, ANDThe treatment must be given concomitantly with standard therapy for this condition.Patient must be at least 12 years of age.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.Tezacaftor with ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.The authority application must be in writing and must include:(1) details of the proposed prescription; AND(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; AND(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.	Compliance with Written Authority Required procedures

[33] Schedule 3, entry for Valganciclovir

(a) omit entry for Circumstances Code “C15782”

(b) omit entry for Circumstances Code “C15784”

(c) omit entry for Circumstances Code “C15800”

(d) omit entry for Circumstances Code “C15814”

(e) insert in numerical order after existing text:

	C19374		Cytomegalovirus infection and diseasePatient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19374
	C19463		Cytomegalovirus infection and diseasePatient must be a solid organ transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19463
	C19505		Cytomegalovirus infection and diseasePatient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19505
	C19515		Cytomegalovirus infection and diseasePatient must be a solid organ transplant recipient at risk of cytomegalovirus disease.Must be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19515

[34] Schedule 3, entry for Zoledronic acid

(a) omit entry for Circumstances Code “C14729”

(b) omit entry for Circumstances Code “C14735”

(c) insert in numerical order after existing text:

	C19289	P19289	Adjuvant management of breast cancerPatient must be post-menopausal.Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months, ANDMust be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19289
	C19428	P19428	Adjuvant management of breast cancerPatient must be post-menopausal.Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months, ANDMust be treated by a specialist medical practitioner; ORMust be treated by an authorised prescriber type (non-specialist medical practitioner, nurse practitioner) where both of the following are occurring: (i) patient care is being shared with a specialist medical practitioner, (ii) the prescription continues existing therapy with this medicine.	Compliance with Authority Required procedures - Streamlined Authority Code 19428

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.