Contents
1. Name#
(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment (October Update) Instrument 2026.
(2)This Instrument may also be cited as PB 113 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 October 2026 | 1 October 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Note: This table relates only to the provisions of this instrument as originally made.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 sections 84AF, 84AK, 85, 85A, 88 and 101 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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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, Part 1, entry for Abemaciclib in the form Tablet 50 mg
(a) omit from the column headed “Circumstances”: C17907
(b) insert in numerical order in the column headed “Circumstances”: C19282
[2] Schedule 1, Part 1, entry for Abemaciclib in the form Tablet 100 mg
(a) omit from the column headed “Circumstances”: C17907
(b) insert in numerical order in the column headed “Circumstances”: C19282
[3] Schedule 1, Part 1, entry for Abemaciclib in the form Tablet 150 mg
(a) omit from the column headed “Circumstances”: C17907
(b) insert in numerical order in the column headed “Circumstances”: C19282
[4] Schedule 1, Part 1, after entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 6]
insert:
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Yuflyma | EW | MP | C15473 C18989 | P15473 P18989 | 2 | 0 | 2 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Yuflyma | EW | MP | C12120 C17707 C17713 C17717 C17719 C17733 C17734 | See Note 3 | See Note 3 | See Note 3 | 2 | C(100) | ||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Yuflyma | EW | MP | C16982 C17031 C17032 C17077 C17715 C17731 C18966 C18967 C18968 | P16982 P17031 P17032 P17077 P17715 P17731 P18966 P18967 P18968 | 2 | 3 | 2 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Yuflyma | EW | MP | C17005 C17042 C17043 C17044 C17045 C17046 | P17005 P17042 P17043 P17044 P17045 P17046 | 2 | 4 | 2 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Yuflyma | EW | MP | C15445 C15446 C16991 C16993 C16999 C17002 C17003 C17030 C17065 C17730 C17736 C18991 | P15445 P15446 P16991 P16993 P16999 P17002 P17003 P17030 P17065 P17730 P17736 P18991 | 2 | 5 | 2 | |||
| Adalimumab | Injection 20 mg in 0.2 mL pre-filled syringe | Injection | Yuflyma | EW | MP | C15474 C15489 | P15474 P15489 | 2 | 6 | 2 |
[5] Schedule 1, Part 1, entries for Allopurinol in the form Tablet 300 mg
omit:
| Allopurinol | Tablet 300 mg | Oral | NOUMED ALLOPURINOL | VO | MP NP | 60 | 2 | 60 | |||||
| Allopurinol | Tablet 300 mg | Oral | NOUMED ALLOPURINOL | VO | MP NP | P14238 | 120 | 2 | 60 |
[6] Schedule 1, Part 1, after entry for Apixaban in the form Tablet 2.5 mg [Brand: Apixaban-APX; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C4359 C4381 | P4359 P4381 | 20 | 0 | 20 | |||
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C4382 C4409 | P4382 P4409 | 30 | 0 | 30 | |||
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C4402 | P4402 | 60 | 0 | 60 | |||
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C4132 C4269 | P4132 P4269 | 60 | 5 | 60 | |||
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C14300 C14301 | P14300 P14301 | 120 | 5 | 60 |
[7] Schedule 1, Part 1, after entry for Apixaban in the form Tablet 2.5 mg [Brand: Apixaban Sandoz; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Viatris | AF | MP NP | C4402 | P4402 | 60 | 0 | 60 | |||
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Viatris | AF | MP NP | C4132 C4269 | P4132 P4269 | 60 | 5 | 60 | |||
| Apixaban | Tablet 2.5 mg | Oral | Apixaban Viatris | AF | MP NP | C14300 C14301 | P14300 P14301 | 120 | 5 | 60 |
[8] Schedule 1, Part 1, after entry for Apixaban in the form Tablet 2.5 mg [Brand: Eliquis; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Apixaban | Tablet 2.5 mg | Oral | MSN-APIXABAN | VM | MP NP | C4359 C4381 | P4359 P4381 | 20 | 0 | 20 | |||
| Apixaban | Tablet 2.5 mg | Oral | MSN-APIXABAN | VM | MP NP | C4382 C4409 | P4382 P4409 | 30 | 0 | 30 | |||
| Apixaban | Tablet 2.5 mg | Oral | MSN-APIXABAN | VM | MP NP | C4402 | P4402 | 60 | 0 | 60 | |||
| Apixaban | Tablet 2.5 mg | Oral | MSN-APIXABAN | VM | MP NP | C4132 C4269 | P4132 P4269 | 60 | 5 | 60 | |||
| Apixaban | Tablet 2.5 mg | Oral | MSN-APIXABAN | VM | MP NP | C14300 C14301 | P14300 P14301 | 120 | 5 | 60 |
[9] Schedule 1, Part 1, after entry for Apixaban in the form Tablet 5 mg [Brand: Apixaban-APX; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Apixaban | Tablet 5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C4269 C18513 C18522 | P4269 P18513 P18522 | 60 | 5 | 60 | |||
| Apixaban | Tablet 5 mg | Oral | Apixaban Dr.Reddy's | RI | MP NP | C14301 C18525 C18527 | P14301 P18525 P18527 | 120 | 5 | 60 |
[10] Schedule 1, Part 1, after entry for Apixaban in the form Tablet 5 mg [Brand: Apixaban Sandoz; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Apixaban | Tablet 5 mg | Oral | Apixaban Viatris | AF | MP NP | C4269 C18513 C18522 | P4269 P18513 P18522 | 60 | 5 | 60 | |||
| Apixaban | Tablet 5 mg | Oral | Apixaban Viatris | AF | MP NP | C14301 C18525 C18527 | P14301 P18525 P18527 | 120 | 5 | 60 |
[11] Schedule 1, Part 1, after entry for Apixaban in the form Tablet 5 mg [Brand: Eliquis; Maximum Quantity: 120; Number of Repeats: 5]
insert:
| Apixaban | Tablet 5 mg | Oral | MSN-APIXABAN | VM | MP NP | C4269 C18513 C18522 | P4269 P18513 P18522 | 60 | 5 | 60 | |||
| Apixaban | Tablet 5 mg | Oral | MSN-APIXABAN | VM | MP NP | C14301 C18525 C18527 | P14301 P18525 P18527 | 120 | 5 | 60 |
[12] Schedule 1, Part 1, entries for Apomorphine
substitute:
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL | Injection | Movapo | TD | MP NP | C10844 | P10844 | 180 | 5 | 5 | |||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL | Injection | Movapo | TD | MP | C11385 C11445 | P11385 P11445 | 180 | 5 | 5 | C(100) | ||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 50 mg in 5 mL | Injection | Movapo | TD | MP NP | C15542 | P15542 | 360 | 5 | 5 | |||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Injection | Apomine Solution for Infusion | IT | MP NP | C10844 | P10844 | 90 | 5 | 5 | |||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Injection | Apomine Solution for Infusion | IT | MP | C10830 C10863 | P10830 P10863 | 90 | 5 | 5 | C(100) | ||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Injection | Apomine Solution for Infusion | IT | MP NP | C15542 | P15542 | 180 | 5 | 5 | |||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Injection | MOVAPO POD | TD | MP NP | C10844 | P10844 | 90 | 5 | 5 | |||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Injection | MOVAPO POD | TD | MP | C10830 C10863 | P10830 P10863 | 90 | 5 | 5 | C(100) | ||
| Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL | Injection | MOVAPO POD | TD | MP NP | C15542 | P15542 | 180 | 5 | 5 | |||
| Apomorphine | Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe | Injection | Movapo PFS | TD | MP NP | C10844 | P10844 | 180 | 5 | 5 | |||
| Apomorphine | Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe | Injection | Movapo PFS | TD | MP | C11385 C11445 | P11385 P11445 | 180 | 5 | 5 | C(100) | ||
| Apomorphine | Solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe | Injection | Movapo PFS | TD | MP NP | C15542 | P15542 | 360 | 5 | 5 | |||
| Apomorphine | Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Apomine Intermittent | IT | MP NP | C10844 | P10844 | 100 | 5 | 5 | |||
| Apomorphine | Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Apomine Intermittent | IT | MP | C10830 C10863 | P10830 P10863 | 100 | 5 | 5 | C(100) | ||
| Apomorphine | Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Apomine Intermittent | IT | MP NP | C15542 | P15542 | 200 | 5 | 5 | |||
| Apomorphine | Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Movapo Pen | TD | MP NP | C10844 | P10844 | 100 | 5 | 5 | |||
| Apomorphine | Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Movapo Pen | TD | MP | C10830 C10863 | P10830 P10863 | 100 | 5 | 5 | C(100) | ||
| Apomorphine | Solution for subcutaneous injection containing apomorphine hydrochloride 30 mg in 3 mL pre-filled pen | Injection | Movapo Pen | TD | MP NP | C15542 | P15542 | 200 | 5 | 5 |
[13] Schedule 1, Part 1, entry for Asciminib in the form Tablet 20 mg [Authorised Prescriber: MP NP]
omit from the column headed “Circumstances”: C19201 substitute: C19234
[14] Schedule 1, Part 1, entry for Asciminib in the form Tablet 20 mg [Authorised Prescriber: MP]
omit from the column headed “Circumstances”: C13950 substitute: C19260
[15] Schedule 1, Part 1, entry for Asciminib in the form Tablet 40 mg [Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C19201 substitute: C19234
(b) omit from the column headed “Purposes”: P19201 substitute: P19234
[16] Schedule 1, Part 1, entry for Asciminib in the form Tablet 40 mg [Authorised Prescriber: MP]
(a) omit from the column headed “Circumstances”: C13950 substitute: C19260
(b) omit from the column headed “Purposes”: P13950 substitute: P19260
[17] Schedule 1, Part 1, entry for Asciminib in the form Tablet 40 mg [Authorised Prescriber: MP NP; Maximum Quantity: 300; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C19202
(b) insert in numerical order in the column headed “Circumstances”: C19277
(c) omit from the column headed “Purposes”: P19202
(d) insert in numerical order in the column headed “Purposes”: P19277
[18] Schedule 1, Part 1, after entry for Bivalirudin [Brand: BIVALIRUDIN MEDSURGE]
insert:
| Bleomycin | Powder for injection containing bleomycin sulfate 15,000 I.U. | Injection | Bleomycin Accord | OC | MP | C6224 C6275 | See Note 3 | See Note 3 | 1 | D(100) |
[19] Schedule 1, Part 1, entry for Blinatumomab
(a) insert in the column headed “Pack Quantity”: 1
(b) omit from the column headed “Determined Quantity”: 1
[20] Schedule 1, Part 1, entries for Ceftriaxone
substitute:
| Ceftriaxone | Powder for injection 500 mg (as sodium) | Injection | Ceftriaxone-AFT | AE | MP MW NP | C5855 | P5855 | 1 | 0 | 1 | |||
| Ceftriaxone | Powder for injection 500 mg (as sodium) | Injection | Ceftriaxone-AFT | AE | MP MW NP | C15964 | P15964 | 5 | 0 | 1 | |||
| Ceftriaxone | Powder for injection 500 mg (as sodium) | Injection | Ceftriaxone-AFT | AE | MP NP | C16029 C16030 | P16029 P16030 | 5 | 0 | 1 | |||
| Ceftriaxone | Powder for injection 1 g (as sodium) | Injection | Ceftriaxone Viatris | AL | MP MW NP | C15964 | 5 | 0 | 10 | ||||
| Ceftriaxone | Powder for injection 1 g (as sodium) | Injection | Ceftriaxone Viatris | AL | MP NP | C16029 C16030 | 5 | 0 | 10 | ||||
| Ceftriaxone | Powder for injection 2 g (as sodium) | Injection | Ceftriaxone Viatris | AL | MP MW NP | C15964 | 5 | 0 | 5 | ||||
| Ceftriaxone | Powder for injection 2 g (as sodium) | Injection | Ceftriaxone Viatris | AL | MP NP | C16029 C16030 | 5 | 0 | 5 | ||||
| Ceftriaxone | Powder for injection 2 g (as sodium) | Injection | Ceftriaxone Viatris | AL | MP MW NP | C15964 | 5 | 0 | 10 | ||||
| Ceftriaxone | Powder for injection 2 g (as sodium) | Injection | Ceftriaxone Viatris | AL | MP NP | C16029 C16030 | 5 | 0 | 10 |
[21] Schedule 1, Part 1, entries for Cefuroxime
substitute:
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | ARX-Cefuroxime | XT | PDP | 14 | 0 | 14 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | ARX-Cefuroxime | XT | MP NP | 14 | 1 | 14 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | ARX-Cefuroxime | XT | PDP | 20 | 0 | 20 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | ARX-Cefuroxime | XT | MP NP | 20 | 1 | 20 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | Pharmacor Cefuroxime | CR | PDP | 14 | 0 | 14 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | Pharmacor Cefuroxime | CR | MP NP | 14 | 1 | 14 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | Pharmacor Cefuroxime | CR | PDP | 20 | 0 | 20 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | Pharmacor Cefuroxime | CR | MP NP | 20 | 1 | 20 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | Zinnat | AS | PDP | 20 | 0 | 20 | |||||
| Cefuroxime | Tablet 250 mg (as axetil) | Oral | Zinnat | AS | MP NP | 20 | 1 | 20 |
[22] Schedule 1, Part 1, entry for Ciclosporin in the form Eye drops 900 micrograms per mL, single dose units 0.25 mL, 60
omit from the column headed “Authorised Prescriber”: MP AO substitute: AO MP
[23] Schedule 1, Part 1, entry for Ciclosporin in the form Eye drops 1 mg per mL, single dose units 0.3 mL, 30
omit from the column headed “Authorised Prescriber”: MP AO substitute: AO MP
[24] Schedule 1, Part 1, after entry for Ciclosporin in the form Eye drops 1 mg per mL, single dose units 0.3 mL, 30
insert:
| Ciclosporin | Eye drops 1 mg per mL, 2 mL | Application to the eye | Vevye | AE | AO MP | C14026 C14032 | 1 | 5 | 1 |
[25] Schedule 1, Part 1, entries for Corifollitropin alfa
omit from the column headed “Responsible Person” (all instances): OQ substitute (all instances): AF
[26] Schedule 1, Part 1, entries for Dasatinib
substitute:
| Dasatinib | Tablet 20 mg | Oral | Dasatinib ARX | XT | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib ARX | XT | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib ARX | XT | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Dr.Reddy's | RI | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Sandoz | SZ | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib SUN | RA | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib SUN | RA | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib SUN | RA | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | DASATINIB-TEVA | TB | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | DASATINIB-TEVA | TB | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | DASATINIB-TEVA | TB | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Viatris | AL | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Viatris | AL | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Dasatinib Viatris | AL | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Sprycel | BQ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Sprycel | BQ | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 20 mg | Oral | Sprycel | BQ | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib ARX | XT | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib ARX | XT | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib ARX | XT | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Dr.Reddy's | RI | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Sandoz | SZ | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib SUN | RA | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib SUN | RA | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib SUN | RA | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | DASATINIB-TEVA | TB | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | DASATINIB-TEVA | TB | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | DASATINIB-TEVA | TB | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Viatris | AL | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Viatris | AL | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Dasatinib Viatris | AL | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Sprycel | BQ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Sprycel | BQ | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 50 mg | Oral | Sprycel | BQ | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib ARX | XT | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib ARX | XT | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib ARX | XT | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Dr.Reddy's | RI | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Sandoz | SZ | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib SUN | RA | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib SUN | RA | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib SUN | RA | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | DASATINIB-TEVA | TB | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | DASATINIB-TEVA | TB | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | DASATINIB-TEVA | TB | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Viatris | AL | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Viatris | AL | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Dasatinib Viatris | AL | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Sprycel | BQ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 60 | 2 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Sprycel | BQ | MP NP | C19225 | P19225 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 70 mg | Oral | Sprycel | BQ | MP | C19223 | P19223 | 60 | 5 | 60 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib ARX | XT | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib ARX | XT | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib ARX | XT | MP | C19223 | P19223 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Dr.Reddy's | RI | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Dr.Reddy's | RI | MP | C19223 | P19223 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Sandoz | SZ | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Sandoz | SZ | MP | C19223 | P19223 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib SUN | RA | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib SUN | RA | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib SUN | RA | MP | C19223 | P19223 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | DASATINIB-TEVA | TB | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | DASATINIB-TEVA | TB | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | DASATINIB-TEVA | TB | MP | C19223 | P19223 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Viatris | AL | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Viatris | AL | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Dasatinib Viatris | AL | MP | C19223 | P19223 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Sprycel | BQ | MP NP | C17817 C17821 C17879 C17984 | P17817 P17821 P17879 P17984 | 30 | 2 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Sprycel | BQ | MP NP | C19225 | P19225 | 30 | 5 | 30 | |||
| Dasatinib | Tablet 100 mg | Oral | Sprycel | BQ | MP | C19223 | P19223 | 30 | 5 | 30 |
[27] Schedule 1, Part 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled pen [Maximum Quantity: See Note 3]
(a) omit from the column headed “Circumstances”: C17073 C17113
(b) insert in numerical order in the column headed “Circumstances”: C19236
[28] Schedule 1, Part 1, entry for Dupilumab in the form Injection 200 mg in 1.14 mL single dose pre-filled syringe [Maximum Quantity: See Note 3]
(a) omit from the column headed “Circumstances”: C17073 C17113
(b) insert in numerical order in the column headed “Circumstances”: C19236
[29] Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled pen [Maximum Quantity: See Note 3]
(a) omit from the column headed “Circumstances”: C17073 C17113
(b) insert in numerical order in the column headed “Circumstances”: C19236
[30] Schedule 1, Part 1, entry for Dupilumab in the form Injection 300 mg in 2 mL single dose pre-filled syringe [Maximum Quantity: See Note 3]
(a) omit from the column headed “Circumstances”: C17073 C17113
(b) insert in numerical order in the column headed “Circumstances”: C19236
[31] Schedule 1, Part 1, entry for Edaravone [Maximum Quantity: 20; Number of Repeats: 2]
(a) omit from the column headed “Circumstances”: C16479 substitute: C19267
(b) omit from the column headed “Purposes”: P16479 substitute: P19267
[32] Schedule 1, Part 1, entry for Edaravone [Maximum Quantity: 28; Number of Repeats: 0]
(a) omit from the column headed “Circumstances”: C18480 substitute: C19252
(b) omit from the column headed “Purposes”: P18480 substitute: P19252
[33] Schedule 1, Part 1, entries for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
omit:
| Etanercept | Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Nepexto | GQ | MP | C12120 C17706 C17707 C17713 C17724 C17725 | See Note 3 | See Note 3 | See Note 3 | 1 | C(100) | ||
| Etanercept | Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Nepexto | GQ | MP | C14508 C14509 | P14508 P14509 | 1 | 1 | 1 | |||
| Etanercept | Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Nepexto | GQ | MP | C9064 C9386 C12261 C14488 C14513 C14553 C14554 C14576 C14577 C14581 C14582 C14603 C14670 C14671 C14673 C14703 C16709 C16710 C16713 C16716 C16717 C16727 C16728 C16737 C16743 C16747 C16761 C16763 C16764 C16773 C16777 C16779 C16785 C16788 C17001 C17069 C17355 | P9064 P9386 P12261 P14488 P14513 P14553 P14554 P14576 P14577 P14581 P14582 P14603 P14670 P14671 P14673 P14703 P16709 P16710 P16713 P16716 P16717 P16727 P16728 P16737 P16743 P16747 P16761 P16763 P16764 P16773 P16777 P16779 P16785 P16788 P17001 P17069 P17355 | 1 | 3 | 1 | |||
| Etanercept | Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Injection | Nepexto | GQ | MP | C9081 C12123 C14499 C14507 C14629 C14683 C14701 C14715 C16718 C16720 C16725 C16750 C16754 C16765 C16766 C16772 C16775 C16778 C16787 C16789 C16792 C16795 C17326 C17374 | P9081 P12123 P14499 P14507 P14629 P14683 P14701 P14715 P16718 P16720 P16725 P16750 P16754 P16765 P16766 P16772 P16775 P16778 P16787 P16789 P16792 P16795 P17326 P17374 | 1 | 5 | 1 |
[34] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge [Maximum Quantity: 2; Number of Repeats: 0]
omit from the column headed “Responsible Person”: OQ substitute: AF
[35] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge [Maximum Quantity: 3; Number of Repeats: 5]
omit from the column headed “Responsible Person”: OQ substitute: AF
[36] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge [Maximum Quantity: 2; Number of Repeats: 5]
omit from the column headed “Responsible Person”: OQ substitute: AF
[37] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 600 I.U. in 0.72 mL multi-dose cartridge [Maximum Quantity: 4; Number of Repeats: 0]
omit from the column headed “Responsible Person”: OQ substitute: AF
[38] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge [Maximum Quantity: 2; Number of Repeats: 5]
omit from the column headed “Responsible Person”: OQ substitute: AF
[39] Schedule 1, Part 1, entry for Follitropin beta in the form Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge [Maximum Quantity: 5; Number of Repeats: 0]
omit from the column headed “Responsible Person”: OQ substitute: AF
[40] Schedule 1, Part 1, after entry for Gabapentin in the form Tablet 600 mg [Brand: Pharmacor Gabapentin 600]
insert:
| Gabapentin | Tablet 800 mg | Oral | APX-GABAPENTIN | XT | MP NP | C17445 | 100 | 5 | 100 |
[41] Schedule 1, Part 1, entries for Gabapentin in the form Tablet 800 mg
omit:
| Gabapentin | Tablet 800 mg | Oral | Gabapentin APOTEX | TY | MP NP | C17445 | 100 | 5 | 100 |
[42] Schedule 1, Part 1, after entry for Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine in the form Sachets containing oral powder 35 g, 30 (PKU Sphere20)
insert:
| Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine | Sachets containing oral powder 40 g, pack of 30 (PKU GMPro Delight) | Oral | PKU GMPro Delight | SB | MP NP | C4295 | 4 | 5 | 1 |
[43] Schedule 1, Part 1, after entry for Griseofulvin in the form Tablet 500 mg
insert:
| Guanfacine | Tablet 1 mg (as hydrochloride) | Oral | Guanfacine MHC | XT | MP NP | C8544 C8585 C9031 C9034 | 28 | 5 | 28 |
[44] Schedule 1, Part 1, after entry for Guanfacine in the form Tablet 1 mg (as hydrochloride) [Brand: Intuniv]
insert:
| Guanfacine | Tablet 2 mg (as hydrochloride) | Oral | Guanfacine MHC | XT | MP NP | C8544 C8585 C9031 C9034 | 28 | 5 | 28 |
[45] Schedule 1, Part 1, after entry for Guanfacine in the form Tablet 2 mg (as hydrochloride) [Brand: Intuniv]
insert:
| Guanfacine | Tablet 3 mg (as hydrochloride) | Oral | Guanfacine MHC | XT | MP NP | C8544 C8585 C9031 C9034 | 28 | 5 | 28 |
[46] Schedule 1, Part 1, after entry for Guanfacine in the form Tablet 3 mg (as hydrochloride) [Brand: Intuniv]
insert:
| Guanfacine | Tablet 4 mg (as hydrochloride) | Oral | Guanfacine MHC | XT | MP NP | C8544 C8585 C9031 C9034 | 28 | 5 | 28 |
[47] Schedule 1, Part 1, entries for Imatinib
substitute:
| Imatinib | Capsule 100 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Capsule 100 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | ARX-IMATINIB | XT | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | IMATINIB-DRLA | RZ | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | Imatinib GH | GQ | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | Imatinib GH | GQ | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | Imatinib GH | GQ | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Capsule 400 mg (as mesilate) | Oral | Imatinib GH | GQ | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Gilmat | CR | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Gilmat | CR | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Gilmat | CR | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Gilmat | CR | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Glivec | NV | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Glivec | NV | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Glivec | NV | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Glivec | NV | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imanib | AF | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imanib | AF | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imanib | AF | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imanib | AF | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP NP | C17826 C17886 | P17826 P17886 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP | C9319 C16238 | P9319 P16238 | 60 | 2 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 60 | 5 | 60 | |||
| Imatinib | Tablet 100 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 60 | 5 | 60 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Gilmat | CR | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Gilmat | CR | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Gilmat | CR | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Gilmat | CR | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Glivec | NV | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Glivec | NV | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Glivec | NV | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Glivec | NV | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imanib | AF | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imanib | AF | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imanib | AF | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imanib | AF | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | IMATINIB RBX | RA | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib Sandoz | SZ | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP | C9319 C16238 | P9319 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP NP | C17884 C17885 C17887 C17890 C17960 C19225 | P17884 P17885 P17887 P17890 P17960 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 400 mg (as mesilate) | Oral | Imatinib-Teva | TB | MP | C9204 C9238 C9240 C9274 C9276 C19223 | P9204 P9238 P9240 P9274 P9276 P19223 | 30 | 5 | 30 | |||
| Imatinib | Tablet 600 mg (as mesilate) | Oral | Imatab | JU | MP NP | C17826 C17886 | P17826 P17886 | 30 | 2 | 30 | |||
| Imatinib | Tablet 600 mg (as mesilate) | Oral | Imatab | JU | MP | C12685 C16238 | P12685 P16238 | 30 | 2 | 30 | |||
| Imatinib | Tablet 600 mg (as mesilate) | Oral | Imatab | JU | MP NP | C17884 C19225 | P17884 P19225 | 30 | 5 | 30 | |||
| Imatinib | Tablet 600 mg (as mesilate) | Oral | Imatab | JU | MP | C9240 C19223 | P9240 P19223 | 30 | 5 | 30 |
[48] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 5 mg
omit:
| Lenalidomide | Capsule 5 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 14 | D(100) | ||
| Lenalidomide | Capsule 5 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 21 | D(100) | ||
| Lenalidomide | Capsule 5 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 28 | D(100) |
[49] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 10 mg
omit:
| Lenalidomide | Capsule 10 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 14 | D(100) | ||
| Lenalidomide | Capsule 10 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 21 | D(100) | ||
| Lenalidomide | Capsule 10 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 28 | D(100) |
[50] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 15 mg
omit:
| Lenalidomide | Capsule 15 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 14 | D(100) | ||
| Lenalidomide | Capsule 15 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 21 | D(100) | ||
| Lenalidomide | Capsule 15 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 28 | D(100) |
[51] Schedule 1, Part 1, entries for Lenalidomide in the form Capsule 25 mg
omit:
| Lenalidomide | Capsule 25 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 14 | D(100) | ||
| Lenalidomide | Capsule 25 mg | Oral | Lenalidomide Dr.Reddy's | RI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 21 | D(100) |
[52] Schedule 1, Part 1, entries for Levetiracetam in the form Tablet 500 mg
omit:
| Levetiracetam | Tablet 500 mg | Oral | Levetiracetam Mylan | AL | MP NP | C17460 | P17460 | 60 | 5 | 60 | |||
| Levetiracetam | Tablet 500 mg | Oral | Levetiracetam Mylan | AL | MP NP | C17543 | P17543 | 120 | 5 | 60 |
[53] Schedule 1, Part 1, entry for Lumasiran [Maximum Quantity: 5; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C17579
(b) omit from the column headed “Purposes”: P17579
[54] Schedule 1, Part 1, entry for Modafinil [Brand: APO-Modafinil]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[55] Schedule 1, Part 1, entry for Modafinil [Brand: Modafin]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[56] Schedule 1, Part 1, entry for Modafinil [Brand: Modafinil GH]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[57] Schedule 1, Part 1, entry for Modafinil [Brand: Modafinil Sandoz]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[58] Schedule 1, Part 1, entry for Modafinil [Brand: Modafinil Viatris]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[59] Schedule 1, Part 1, entry for Modafinil [Brand: MODAFINIL-WGR]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[60] Schedule 1, Part 1, entry for Modafinil [Brand: Modavigil]
(a) omit from the column headed “Circumstances”: C10970
(b) insert in numerical order in the column headed “Circumstances”: C18333
[61] Schedule 1, Part 1, entries for Nilotinib
substitute:
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | Ceahani | NM | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | Ceahani | NM | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | MSN-NILOTINIB | HK | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | MSN-NILOTINIB | HK | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | NILOTAS | CR | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | NILOTAS | CR | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | Tasigna | NV | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 150 mg (as hydrochloride) | Oral | Tasigna | NV | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | Ceahani | NM | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | Ceahani | NM | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | MSN-NILOTINIB | HK | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | MSN-NILOTINIB | HK | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | NILOTAS | CR | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | NILOTAS | CR | MP | C19223 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | Tasigna | NV | MP NP | C19225 | 120 | 5 | 120 | ||||
| Nilotinib | Capsule 200 mg (as hydrochloride) | Oral | Tasigna | NV | MP | C19223 | 120 | 5 | 120 |
[62] Schedule 1, Part 1, entries for Olmesartan in the form Tablet containing olmesartan medoxomil 20 mg
omit:
| Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Oral | APX-Olmesartan | TY | MP NP | 30 | 5 | 30 | |||||
| Olmesartan | Tablet containing olmesartan medoxomil 20 mg | Oral | APX-Olmesartan | TY | MP NP | P14238 | 60 | 5 | 30 |
[63] Schedule 1, Part 1, entries for Olmesartan in the form Tablet containing olmesartan medoxomil 40 mg
omit:
| Olmesartan | Tablet containing olmesartan medoxomil 40 mg | Oral | APX-Olmesartan | TY | MP NP | 30 | 5 | 30 | |||||
| Olmesartan | Tablet containing olmesartan medoxomil 40 mg | Oral | APX-Olmesartan | TY | MP NP | P14238 | 60 | 5 | 30 |
[64] Schedule 1, Part 1, entries for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg
omit:
| Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg | Oral | APX-Olmesartan/HCTZ | TY | MP NP | 30 | 5 | 30 | ||||||
| Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 20 mg with hydrochlorothiazide 12.5 mg | Oral | APX-Olmesartan/HCTZ | TY | MP NP | P14238 | 60 | 5 | 30 |
[65] Schedule 1, Part 1, entries for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg
omit:
| Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg | Oral | APX-Olmesartan/HCTZ | TY | MP NP | 30 | 5 | 30 | |||||
| Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 12.5 mg | Oral | APX-Olmesartan/HCTZ | TY | MP NP | P14238 | 60 | 5 | 30 |
[66] Schedule 1, Part 1, entries for Olmesartan with hydrochlorothiazide in the form Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg
omit:
| Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | Oral | APX-Olmesartan/HCTZ | TY | MP NP | 30 | 5 | 30 | |||||
| Olmesartan with hydrochlorothiazide | Tablet containing olmesartan medoxomil 40 mg with hydrochlorothiazide 25 mg | Oral | APX-Olmesartan/HCTZ | TY | MP NP | P14238 | 60 | 5 | 30 |
[67] Schedule 1, Part 1, after entry for Olsalazine in the form Tablet containing olsalazine sodium 500 mg
insert:
| Omalizumab | Injection 75 mg in 0.5 mL single dose pre-filled pen | Injection | Omlyclo | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
[68] Schedule 1, Part 1, after entry for Omalizumab in the form Injection 75 mg in 0.5 mL single dose pre-filled syringe [Brand: Xolair]
insert:
| Omalizumab | Injection 150 mg in 1 mL single dose pre-filled pen | Injection | Omlyclo | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
[69] Schedule 1, Part 1, after entry for Paclitaxel, nanoparticle albumin-bound [Brand: Abraxane]
insert:
| Paclitaxel, nanoparticle albumin-bound | Powder for I.V. injection containing 100 mg paclitaxel | Injection | nab-Paclitaxel Accord | OC | MP | C4657 C6106 C6119 | See Note 3 | See Note 3 | 1 | D(100) |
[70] Schedule 1, Part 1, entry for Pembrolizumab
(a) omit from the column headed “Circumstances”: C18371
(b) omit from the column headed “Circumstances”: C18450
[71] Schedule 1, Part 1, entry for Ponatinib in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 60; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C17989 C18011 C18012 C18031 substitute: C19226 C19246 C19255
(b) omit from the column headed “Purposes”: P17989 P18011 P18012 P18031 substitute: P19226 P19246 P19255
[72] Schedule 1, Part 1, entry for Ponatinib in the form Tablet 45 mg (as hydrochloride) [Maximum Quantity: 30; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C17989 C18011 C18012 C18031 substitute: C19226 C19246 C19255
(b) omit from the column headed “Purposes”: P17989 P18011 P18012 P18031 substitute: P19226 P19246 P19255
[73] Schedule 1, Part 1, entry for Ribociclib [Maximum Quantity: 21; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C17995
(b) insert in numerical order in the column headed “Circumstances”: C19283
(c) omit from the column headed “Purposes”: P17995
(d) insert in numerical order in the column headed “Purposes”: P19283
[74] Schedule 1, Part 1, entry for Ribociclib [Maximum Quantity: 42; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C17975
(b) insert in numerical order in the column headed “Circumstances”: C19280
(c) omit from the column headed “Purposes”: P17975
(d) insert in numerical order in the column headed “Purposes”: P19280
[75] Schedule 1, Part 1, after entry for Risedronic acid in the form Tablet containing risedronate sodium 150 mg [Brand: APO-Risedronate; Maximum Quantity: 2; Number of Repeats: 5]
insert:
| Risedronic acid | Tablet containing risedronate sodium 150 mg | Oral | Risedronate Way | IX | MP NP | C6310 C6323 C6327 | P6310 P6323 P6327 | 1 | 5 | 1 | |||
| Risedronic acid | Tablet containing risedronate sodium 150 mg | Oral | Risedronate Way | IX | MP NP | C14234 C14235 C14263 | P14234 P14235 P14263 | 2 | 5 | 1 |
[76] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 12.5 mg [Brand: Sunitinib Sandoz; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[77] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 12.5 mg [Brand: Sutent; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[78] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg [Brand: ARX-Sunitinib; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[79] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg [Brand: Sunitinib Sandoz; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[80] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 25 mg [Brand: Sutent; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[81] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg [Brand: ARX-Sunitinib; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[82] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg [Brand: Sunitinib Sandoz; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[83] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 37.5 mg [Brand: Sutent; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[84] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg [Brand: ARX-Sunitinib; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[85] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg [Brand: Sunitinib Sandoz; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[86] Schedule 1, Part 1, entry for Sunitinib in the form Capsule 50 mg [Brand: Sutent; Authorised Prescriber: MP; Maximum Quantity: 28; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C13152
(b) insert in numerical order in the column headed “Circumstances”: C19250
(c) omit from the column headed “Purposes”: P13152
(d) insert in numerical order in the column headed “Purposes”: P19250
[87] Schedule 1, Part 1, after entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release) [Brand: Tacrolimus XR Sandoz; Maximum Quantity: 60; Number of Repeats: 3]
insert:
| Tacrolimus | Ointment 1 mg per g, 30 g | Application | aZematop | XT | MP NP | C19259 | 1 | 1 | 1 |
[88] Schedule 1, Part 1, after entry for Tocilizumab in the form Concentrate for injection 80 mg in 4 mL
insert:
| Tocilizumab | Concentrate for injection 80 mg in 4 mL | Injection | Avtozma | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
[89] Schedule 1, Part 1, after entry for Tocilizumab in the form Concentrate for injection 200 mg in 10 mL
insert:
| Tocilizumab | Concentrate for injection 200 mg in 10 mL | Injection | Avtozma | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
[90] Schedule 1, Part 1, after entry for Tocilizumab in the form Concentrate for injection 400 mg in 20 mL
insert:
| Tocilizumab | Concentrate for injection 400 mg in 20 mL | Injection | Avtozma | EW | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
[91] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C14195
(b) omit from the column headed “Circumstances”: C18697 C18711
(c) insert in numerical order in the column headed “Circumstances”: C18944 C18945 C18947 C19268
(d) omit from the column headed “Purposes”: P14195
(e) omit from the column headed “Purposes”: P18697 P18711
(f) insert in numerical order in the column headed “Purposes”: P18944 P18945 P18947 P19268
[92] Schedule 1, Part 1, after entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled pen [Maximum Quantity: 4; Number of Repeats: 6]
insert:
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Avtozma | EW | MP | C10560 | P10560 | 4 | 0 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Avtozma | EW | MP | C9477 C14094 C14121 C14182 C17709 C17748 C17760 C18639 C19002 | P9477 P14094 P14121 P14182 P17709 P17748 P17760 P18639 P19002 | 4 | 1 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Avtozma | EW | MP | C14084 C17710 C17742 | P14084 P17710 P17742 | 4 | 2 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Avtozma | EW | MP | C14080 C14147 C14175 C18534 C18562 C18565 C18584 C18601 C18604 C18638 C18661 C18670 C18696 C18948 C19004 C19027 C19041 | P14080 P14147 P14175 P18534 P18562 P18565 P18584 P18601 P18604 P18638 P18661 P18670 P18696 P18948 P19004 P19027 P19041 | 4 | 3 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Avtozma | EW | MP | C14088 C14499 C14507 C16725 C18938 C18939 C18944 C18945 C18947 C19036 C19268 | P14088 P14499 P14507 P16725 P18938 P18939 P18944 P18945 P18947 P19036 P19268 | 4 | 5 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Avtozma | EW | MP | C9180 C19020 | P9180 P19020 | 4 | 6 | 4 |
[93] Schedule 1, Part 1, entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C14195
(b) omit from the column headed “Circumstances”: C18697 C18711
(c) insert in numerical order in the column headed “Circumstances”: C18944 C18945 C18947 C19268
(d) omit from the column headed “Purposes”: P14195
(e) omit from the column headed “Purposes”: P18697 P18711
(f) insert in numerical order in the column headed “Purposes”: P18944 P18945 P18947 P19268
[94] Schedule 1, Part 1, after entry for Tocilizumab in the form Injection 162 mg in 0.9 mL single use pre-filled syringe [Maximum Quantity: 4; Number of Repeats: 6]
insert:
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Avtozma | EW | MP | C10560 | P10560 | 4 | 0 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Avtozma | EW | MP | C9477 C14094 C14121 C14182 C17709 C17748 C17760 C18639 C19002 | P9477 P14094 P14121 P14182 P17709 P17748 P17760 P18639 P19002 | 4 | 1 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Avtozma | EW | MP | C14084 C17710 C17742 | P14084 P17710 P17742 | 4 | 2 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Avtozma | EW | MP | C14080 C14147 C14175 C18534 C18562 C18565 C18584 C18601 C18604 C18638 C18661 C18670 C18696 C18948 C19004 C19027 C19041 | P14080 P14147 P14175 P18534 P18562 P18565 P18584 P18601 P18604 P18638 P18661 P18670 P18696 P18948 P19004 P19027 P19041 | 4 | 3 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Avtozma | EW | MP | C14088 C14499 C14507 C16725 C18938 C18939 C18944 C18945 C18947 C19036 C19268 | P14088 P14499 P14507 P16725 P18938 P18939 P18944 P18945 P18947 P19036 P19268 | 4 | 5 | 4 | |||
| Tocilizumab | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Avtozma | EW | MP | C9180 C19020 | P9180 P19020 | 4 | 6 | 4 |
[95] Schedule 1, Part 1, after entry for Tofacitinib in the form Tablet 10 mg [Maximum Quantity: 56; Number of Repeats: 5]
insert:
| Tofersen | Solution for intrathecal injection 100 mg in 15 mL | Injection | Qalsody | BD | MP | C19261 | P19261 | 1 | 2 | 1 | D(100) | ||
| Tofersen | Solution for intrathecal injection 100 mg in 15 mL | Injection | Qalsody | BD | MP | C19237 C19253 | P19237 P19253 | 1 | 5 | 1 | D(100) | ||
| Tofersen | Solution for intrathecal injection 100 mg in 15 mL | Injection | Qalsody | BD | MP | C19231 C19243 | P19231 P19243 | 1 | 6 | 1 | D(100) |
[96] Schedule 1, Part 1, entry for Triptorelin in the form Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles
omit from the column headed “Circumstances”: C17812
[97] Schedule 1, Part 1, after entry for Varenicline in the form Box containing 11 tablets 0.5 mg and 42 tablets 1 mg [Brand: Varenicline Viatris]
insert:
| Varenicline | Box containing 11 tablets 0.5 mg and 42 tablets 1 mg | Oral | VASSIX | NB | MP NP | C6871 | 1 | 0 | 1 |
[98] Schedule 1, Part 1, after entry for Varenicline in the form Tablet 1 mg [Brand: Varenicline Viatris; Maximum Quantity: 112; Number of Repeats: 0]
insert:
| Varenicline | Tablet 1 mg | Oral | VASSIX | NB | MP NP | C6885 | P6885 | 56 | 2 | 56 | |||
| Varenicline | Tablet 1 mg | Oral | VASSIX | NB | MP NP | C7483 | P7483 | 112 | 0 | 56 |
[99] Schedule 1, Part 2, entries for Beclometasone
omit:
| Beclometasone | Pressurised inhalation in breath actuated device containing beclometasone dipropionate 50 micrograms per dose, 200 doses (CFC-free formulation) | Inhalation by mouth | Qvar 50 Autohaler | IL | 1 |
[100] Schedule 1, Part 2, omit entry for Insulin glulisine
[101] Schedule 1, Part 2, omit entry for Salbutamol
[102] Schedule 3, after entry for Responsible Person Code HJ
insert:
| HK | SEED PHARMA PTY. LTD. | 81 612 154 373 |
[103] Schedule 3, after entry for Responsible Person Code VK
insert:
| VM | MSN LABORATORIES AUSTRALIA PTY LTD | 78 686 372 716 |
[104] Schedule 3
omit:
| VO | Avallon Pharmaceuticals Pty Limited | 63 126 872 848 |
[105] Schedule 4, Part 1, omit entry for Circumstances Code “C10970”
[106] Schedule 4, Part 1, omit entry for Circumstances Code “C12524”
[107] Schedule 4, Part 1, omit entry for Circumstances Code “C12527”
[108] Schedule 4, Part 1, omit entry for Circumstances Code “C12529”
[109] Schedule 4, Part 1, omit entry for Circumstances Code “C12541”
[110] Schedule 4, Part 1, omit entry for Circumstances Code “C12543”
[111] Schedule 4, Part 1, omit entry for Circumstances Code “C12549”
[112] Schedule 4, Part 1, omit entry for Circumstances Code “C12557”
[113] Schedule 4, Part 1, omit entry for Circumstances Code “C12561”
[114] Schedule 4, Part 1, omit entry for Circumstances Code “C12569”
[115] Schedule 4, Part 1, omit entry for Circumstances Code “C12570”
[116] Schedule 4, Part 1, omit entry for Circumstances Code “C13152”
[117] Schedule 4, Part 1, omit entry for Circumstances Code “C13950”
[118] Schedule 4, Part 1, omit entry for Circumstances Code “C14195”
[119] Schedule 4, Part 1, entry for Circumstances Code “C14582”
substitute:
| C14582 | P14582 | CN14582 | Etanercept | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition. ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records.An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Authority Required procedures |
[120] Schedule 4, Part 1, entry for Circumstances Code “C14590”
substitute:
| C14590 | P14590 | CN14590 | Adalimumab | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records.An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Authority Required procedures |
[121] Schedule 4, Part 1, omit entry for Circumstances Code “C16479”
[122] Schedule 4, Part 1, entry for Circumstances Code “C16709”
substitute:
| C16709 | P16709 | CN16709 | Etanercept | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
[123] Schedule 4, Part 1, omit entry for Circumstances Code “C17073”
[124] Schedule 4, Part 1, omit entry for Circumstances Code “C17113”
[125] Schedule 4, Part 1, omit entry for Circumstances Code “C17579”
[126] Schedule 4, Part 1, omit entry for Circumstances Code “C17822”
[127] Schedule 4, Part 1, omit entry for Circumstances Code “C17829”
[128] Schedule 4, Part 1, omit entry for Circumstances Code “C17830”
[129] Schedule 4, Part 1, omit entry for Circumstances Code “C17833”
[130] Schedule 4, Part 1, omit entry for Circumstances Code “C17889”
[131] Schedule 4, Part 1, omit entry for Circumstances Code “C17895”
[132] Schedule 4, Part 1, omit entry for Circumstances Code “C17907”
[133] Schedule 4, Part 1, omit entry for Circumstances Code “C17922”
[134] Schedule 4, Part 1, omit entry for Circumstances Code “C17975”
[135] Schedule 4, Part 1, omit entry for Circumstances Code “C17989”
[136] Schedule 4, Part 1, omit entry for Circumstances Code “C17995”
[137] Schedule 4, Part 1, omit entry for Circumstances Code “C18010”
[138] Schedule 4, Part 1, omit entry for Circumstances Code “C18011”
[139] Schedule 4, Part 1, omit entry for Circumstances Code “C18012”
[140] Schedule 4, Part 1, omit entry for Circumstances Code “C18031”
[141] Schedule 4, Part 1, entry for Circumstances Code “C18333”
insert in alphabetical order in the column headed “Listed Drug”: Modafinil
[142] Schedule 4, Part 1, omit entry for Circumstances Code “C18371”
[143] Schedule 4, Part 1, omit entry for Circumstances Code “C18450”
[144] Schedule 4, Part 1, omit entry for Circumstances Code “C18480”
[145] Schedule 4, Part 1, entry for Circumstances Code “C18562”
substitute:
| C18562 | P18562 | CN18562 | AdalimumabBaricitinibTocilizumabTofacitinibUpadacitinib | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription; and(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
[146] Schedule 4, Part 1, entry for Circumstances Code “C18598”
substitute:
| C18598 | P18598 | CN18598 | Certolizumab pegol | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
[147] Schedule 4, Part 1, entry for Circumstances Code “C18635”
substitute:
| C18635 | P18635 | CN18635 | AbataceptGolimumab | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Must be treated by a rheumatologist. orMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition. orPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication. ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition. ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times. ANDPatient must not receive more than 16 weeks of treatment under this restriction. ANDThe treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; OR(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
[148] Schedule 4, Part 1, omit entry for Circumstances Code “C18697”
[149] Schedule 4, Part 1, omit entry for Circumstances Code “C18711”
[150] Schedule 4, Part 1, after entry for Circumstances Code “C18931”
insert:
| C18938 | P18938 | CN18938 | Tocilizumab | Severe active rheumatoid arthritisFirst continuing treatment - balance of supplyPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. | Compliance with Authority Required procedures - Streamlined Authority Code 18938 |
| C18939 | P18939 | CN18939 | Tocilizumab | Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; or(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The measurement of response to the prior course of therapy must be documented in the patient's medical notes.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. | Compliance with Authority Required procedures - Streamlined Authority Code 18939 |
| C18944 | P18944 | CN18944 | Tocilizumab | Severe active juvenile idiopathic arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; OR(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; OR(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C18945 | P18945 | CN18945 | Tocilizumab | Severe active juvenile idiopathic arthritisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) an active joint count of fewer than 10 active (swollen and tender) joints; OR(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; OR(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.The authority application must be made in writing and must include:(1) details of the proposed prescription, AND(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient doses for up to 24 weeks treatment. Up to a maximum of 5 repeats will be authorised.Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction. | Compliance with Written Authority Required procedures |
| C18947 | P18947 | CN18947 | Tocilizumab | Severe active juvenile idiopathic arthritisBalance of supply - Continuing treatmentPatient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; ORPatient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment, ANDThe treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. | Compliance with Authority Required procedures |
| C18948 | P18948 | CN18948 | Tocilizumab | Severe active rheumatoid arthritisInitial treatment - Initial 1 (new patient)Patient must not have received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; ORPatient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; ORPatient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records.The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records.The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either(a) a total active joint count of at least 20 active (swollen and tender) joints; or(b) at least 4 active joints from the following list of major joints:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to prior treatment must be documented in the patient's medical records.The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the active joint count, ESR and/or CRP result and date of results;(b) details of prior treatment, including dose and date/duration of treatment.(c) If applicable, details of any contraindications/intolerances.(d) If applicable, the maximum tolerated dose of methotrexate.An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
[151] Schedule 4, Part 1, after entry for Circumstances Code “C18999”
insert:
| C19002 | P19002 | P19002 | Tocilizumab | Severe active juvenile idiopathic arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab.Must be treated by a paediatric rheumatologist; ORPatient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.Patient must be under 18 years of age.Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.An adequate response to treatment is defined as:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C19004 | P19004 | CN19004 | Tocilizumab | Severe active rheumatoid arthritisInitial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)Patient must have been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021, ANDPatient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
[152] Schedule 4, Part 1, after entry for Circumstances Code “C19016”
insert:
| C19020 | P19020 | CN19020 | Tocilizumab | Active giant cell arteritisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDThe treatment must not exceed 52 weeks in total including initial and continuing applications.Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis. | Compliance with Authority Required procedures - Streamlined Authority Code 19020 |
[153] Schedule 4, Part 1, after entry for Circumstances Code “C19021”
insert:
| C19027 | P19027 | CN19027 | Tocilizumab | Severe active rheumatoid arthritisInitial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; ORPatient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.Patients who have received PBS-subsidised treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records.An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Authority Required procedures |
[154] Schedule 4, Part 1, after entry for Circumstances Code “C19035”
insert:
| C19036 | P19036 | CN19036 | Tocilizumab | Severe active rheumatoid arthritisFirst continuing treatmentPatient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition, ANDPatient must have demonstrated an adequate response to treatment with this drug, ANDPatient must not receive more than 24 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.An adequate response to treatment is defined as:an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;AND either of the following:(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the prescribing.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 19036 |
[155] Schedule 4, Part 1, after entry for Circumstances Code “C19038”
insert:
| C19041 | P19041 | CN19041 | Tocilizumab | Severe active rheumatoid arthritisInitial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition, ANDPatient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition, ANDPatient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition, ANDPatient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times, ANDThe condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; ORThe condition must have a C-reactive protein (CRP) level greater than 15 mg per L, ANDThe condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints, ANDPatient must not receive more than 16 weeks of treatment under this restriction.Must be treated by a rheumatologist; ORMust be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.Patient must be at least 18 years of age.Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:(a) the active joint count, ESR and/or CRP result and date of result;(b) the most recent biological agent and the date of the last continuing prescription.(c) If applicable, the new baseline scores.To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
[156] Schedule 4, Part 1, omit entry for Circumstances Code “C19201”
[157] Schedule 4, Part 1, omit entry for Circumstances Code “C19202”
[158] Schedule 4, Part 1, after entry for Circumstances Code “C19222”
insert:
| C19223 | P19223 | CN19223 | DasatinibImatinibNilotinib | Chronic Myeloid Leukaemia (CML)Initial treatmentPatient must have a primary diagnosis of chronic myeloid leukaemia, ANDPatient must not have previously experienced an inadequate response to PBS-subsidised treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C19225 | P19225 | CN19225 | DasatinibImatinibNilotinib | Chronic Myeloid Leukaemia (CML)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be responding to treatment with this drug for this condition, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19225 |
| C19226 | P19226 | CN19226 | Ponatinib | Chronic Myeloid Leukaemia (CML)Continuing treatmentPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals; ORPatient must have demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C19231 | P19231 | CN19231 | Tofersen | Amyotrophic lateral sclerosisInitial treatmentPatient must have/have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing treatment with this drug, ANDThe condition must have been diagnosed by a neurologist, ANDThe condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.The following must be documented in the patient's medical records:a) date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant, ANDb) baseline score of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) at treatment initiation. | Compliance with Authority Required procedures |
| C19234 | P19234 | CN19234 | Asciminib | Chronic Myeloid Leukaemia (CML)Continuing treatment for patients without T315I mutationPatient must have received initial PBS-subsidised treatment with this drug for this condition, ANDPatient must be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%; ORPatient must be undergoing subsequent continuing treatment with this drug, demonstrating a response at 12-monthly intervals of either: (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. | Compliance with Authority Required procedures - Streamlined Authority Code 19234 |
| C19236 | P19236 | CN19236 | Dupilumab | Uncontrolled severe asthmaInitial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy), Initial treatment - Initial 2 (Change of treatment), Continuing treatment - Balance of Supply in a patient aged 6 to 12 yearsPatient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 1 (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS-subsidised biological medicine therapy) restriction to complete 32 weeks of treatment; ORPatient must have received insufficient therapy with this drug for this condition under the Initial treatment - Initial 2 (Change of treatment) restriction to complete 32 weeks of treatment; ORPatient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment, ANDThe treatment must provide no more than the balance of up to 32 weeks treatment available under the Initial 1 and Initial 2 restriction; ORThe treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing restriction.Must be treated by a medical practitioner who is either a:(i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. | Compliance with Authority Required procedures |
| C19237 | P19237 | CN19237 | Tofersen | Amyotrophic lateral sclerosisSubsequent continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the first continuing treatment, the extended first continuing treatment or the grandfather treatment restriction, ANDPatient must have demonstrated an adequate response to treatment defined as any improvement or stabilisation in the ALSFRS-R score (i.e. no more than a 20% decline from the baseline ALSFRS-R score), if they have received treatment under the first continuing or extended first continuing restriction; ORPatient must have demonstrated a clinical benefit from treatment, based on clinician judgment, within 12 months of treatment initiation, if they have received treatment under the grandfather listing, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis. | Compliance with Authority Required procedures |
| C19243 | P19243 | CN19243 | Tofersen | Amyotrophic lateral sclerosisFirst continuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.Assessment of response must be conducted after 6 months of the first continuing treatment (i.e. at 12 months from treatment initiation).If a response to treatment cannot be demonstrated at this assessment, prescribers may apply for up to a maximum of three months (i.e. 2 repeats) of additional continuing treatment under the extended first continuing treatment phase to verify non-response.Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.All the assessments of response must be documented in the patient's medical records.Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R. | Compliance with Authority Required procedures |
| C19246 | P19246 | CN19246 | Ponatinib | Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients with T315I mutationPatient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale, AND(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
| C19250 | P19250 | CN19250 | Sunitinib | Metastatic or unresectable malignant gastrointestinal stromal tumourInitial treatmentThe condition must not be resectable, ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, ANDPatient must have a WHO performance status of 2 or less, ANDPatient must have previously failed or be intolerant to imatinib mesilate.Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.If the application is submitted through HPOS form upload or mail, it must include:(a) details of the proposed prescription, AND(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib. | Compliance with Written Authority Required procedures |
| C19252 | P19252 | CN19252 | Edaravone | Amyotrophic lateral sclerosisInitial treatmentThe condition must be/have been diagnosed by a neurologist, ANDPatient must not have had symptoms for more than 2 years prior to commencing therapy with this drug, ANDPatient must have at least 80 percent of predicted forced vital capacity (FVC) or slow vital capacity (SVC) within the 2 months prior to commencing therapy with this drug, ANDPatient must not require assistance with eating or ambulation prior to commencing treatment with this drug, ANDPatient must have at least two points on each individual item of the ALS Functional Rating Scale - Revised (ALSFRS-R) score prior to commencing therapy with this drug, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving concomitant treatment with tofersen for this condition.The date of diagnosis, the date and results of spirometry (in terms of percent of predicted forced vital capacity or slow vital capacity) must be supplied with the initial authority application.Prescribers must request a quantity sufficient to cover one month per dispensing, in accordance with the patient's treatment cycle. Prescribers must request a smaller number of units than the listed maximum quantity units if it is adequate for the patient's needs. | Compliance with Authority Required procedures |
| C19253 | P19253 | CN19253 | Tofersen | Amyotrophic lateral sclerosisGrandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatmentPatient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2026, ANDPatient must have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing non-PBS-subsidised treatment with this drug, ANDThe condition must have been diagnosed by a neurologist, ANDThe condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.The date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant must be documented in the patient's medical records.A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria. | Compliance with Authority Required procedures |
| C19255 | P19255 | CN19255 | Ponatinib | Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients without T315I mutationPatient must have experienced an inadequate response to an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal, ANDPatient must have experienced an inadequate response to an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale, AND(iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.All reports must be documented in the patient's medical recordsIf the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
| C19259 | P19259 | CN19259 | Tacrolimus | Moderate to severe atopic dermatitisFlare treatmentPatient must have 1 or more of the following contraindications to topical corticosteroids: (i) perioral dermatitis; (ii) periorbital dermatitis; (iii) rosacea; (iv) epidermal atrophy; (v) dermal atrophy; (vi) allergy to topical corticosteroids; (vii) cataracts; (viii) glaucoma; (ix) raised intraocular pressure. ORThe condition must not have been adequately controlled with topical corticosteroid therapy.Inadequate control of this condition with topical corticosteroid therapy is defined as:(i) no clearance of the skin despite at least 2 weeks of a potent topical corticosteroid for the body or a mild topical corticosteroid for the face and eyelids, applied every day; OR(ii) clearing of the skin with at least 2 weeks of a potent topical corticosteroid for the body or a mild topical corticosteroid for the face and eyelids, applied every day, but almost immediate and significant flare in disease (within 48 hours) upon stopping topical corticosteroids, occurring on at least 2 consecutive occasions.Treatment should be discontinued, and further treatment options should be considered if no signs of improvement are seen after 2 weeks of treatment.Once clearance or near clearance of atopic dermatitis is achieved, patients should cease tacrolimus treatment and reinitiate only if there is a flare of their atopic dermatitis that meets the PBS eligibility criteria. | Compliance with Authority Required procedures |
| C19260 | P19260 | CN19260 | Asciminib | Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients without T315I mutationThe condition must not be in the blast phase, ANDPatient must have experienced an inadequate response to an adequate trial of at least two tyrosine kinase inhibitors; ORPatient must have experienced intolerance, not an inadequate response, to at least two tyrosine kinase inhibitors; ORPatient must have experienced an inadequate response to an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Blast phase defined according to the latest WHO criteria.A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C19261 | P19261 | CN19261 | Tofersen | Amyotrophic lateral sclerosisExtended first continuing treatment (additional 3 doses)Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction, ANDPatient must not have demonstrated an adequate response to treatment with this drug for this condition, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving palliative (end of life) care, ANDThe treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition, ANDPatient must not be receiving concomitant treatment with edaravone for this condition.Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.All the assessments of response must be documented in the patient's medical records.Patient may qualify for this treatment phase once only.Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R. | Compliance with Authority Required procedures |
| C19267 | P19267 | CN19267 | Edaravone | Amyotrophic lateral sclerosisContinuing treatmentPatient must have previously received PBS-subsidised treatment with this drug for this condition, ANDPatient must not have undergone a tracheostomy, ANDPatient must not have experienced respiratory failure, ANDPatient must not be receiving concomitant treatment with tofersen for this condition. | Compliance with Authority Required procedures |
| C19268 | P19268 | CN19268 | Tocilizumab | Active giant cell arteritisInitial treatmentMust be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause, ANDPatient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; ORPatient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; ORPatient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging, ANDPatient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis, ANDPatient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; ORPatient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; ORPatient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis, ANDThe treatment must be in combination with a tapering course of corticosteroids, ANDThe treatment must not exceed 52 weeks in total including initial and continuing applications.Patient must be aged 50 years or older.Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging, AND(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C19277 | P19277 | CN19277 | Asciminib | Chronic Myeloid Leukaemia (CML)Initial PBS-subsidised treatment for patients with T315I mutationThe condition must not be in the blast phase, ANDPatient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report, ANDThe condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; ORThe condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR), ANDPatient must have experienced an inadequate response to an adequate trial of at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority; ORPatient must have experienced intolerance, not an inadequate response, to at least one tyrosine kinase inhibitor, ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a medical practitioner.The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; OR(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale, AND(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation, AND(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.All reports must be documented in the patient's medical records.If the application is submitted through HPOS form upload or mail, it must include:(i) details of the proposed prescription, AND(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapyUp to a maximum of 18 months of treatment may be authorised under this initial restriction.Blast phase defined according to the latest WHO criteria.A pathology cytogenetic report from an Approved Pathology Authority conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C19280 | P19280 | CN19280 | Ribociclib | Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab.Must be treated by a medical practitioner; ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine, ANDPatient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
| C19282 | P19282 | CN19282 | Abemaciclib | Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib.Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit, ANDMust be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
| C19283 | P19283 | CN19283 | Ribociclib | Early breast cancerThe treatment must be adjuvant to surgical resection, ANDPatient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; ORPatient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, ANDThe condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing a CDK4/6 inhibitor therapy for this condition, ANDThe condition must be human epidermal growth factor receptor 2 (HER2) negative, ANDThe condition must be hormone receptor positive, ANDThe condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), ANDThe treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 3 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, ANDThe treatment must not be in combination with any of the following: (i) abemaciclib, (ii) olaparib, (iii) pembrolizumab, ANDPatient must require dosage reduction requiring a pack of 21 tablets.Patient must be undergoing concurrent treatment with a non-steroidal aromatase inhibitor where this drug is being prescribed as a PBS benefit, ANDMust be treated by a medical practitioner. ORMust be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine.Retain all pathology imaging and investigative test results in the patient's medical records.PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available). | Compliance with Authority Required procedures |
[159] Schedule 5, entry for Adalimumab in the form Injection 20 mg in 0.2 mL pre-filled syringe
insert in the column headed “Brand” after entry for the brand “Humira”: Yuflyma
[160] Schedule 5, entry for Allopurinol [GRP-980]
omit from the column headed “Brand”: NOUMED ALLOPURINOL
[161] Schedule 5, entry for Apixaban [GRP-31009]
(a) insert in the column headed “Brand” after entry for the brand “Apixaban-APX”: Apixaban Dr.Reddy's
(b) insert in the column headed “Brand” after entry for the brand “Eliquis”: MSN-APIXABAN
[162] Schedule 5, entry for Apixaban [GRP-31011]
(a) insert in the column headed “Brand” after entry for the brand “Apexa”: Apixaban Dr.Reddy's
(b) insert in the column headed “Brand” after entry for the brand “Eliquis”: MSN-APIXABAN
[163] Schedule 5, entry for Apixaban [GRP-31028]
(a) insert in the column headed “Brand” after entry for the brand “Apixaban-APX”: Apixaban Dr.Reddy's
(b) insert in the column headed “Brand” after entry for the brand “Apixaban Sandoz”: Apixaban Viatris
(c) insert in the column headed “Brand” after entry for the brand “Eliquis”: MSN-APIXABAN
[164] Schedule 5, entry for Apixaban [GRP-31030]
(a) insert in the column headed “Brand” after entry for the brand “Apixaban-APX”: Apixaban Dr.Reddy's
(b) insert in the column headed “Brand” after entry for the brand “Apixaban Sandoz”: Apixaban Viatris
(c) insert in the column headed “Brand” after entry for the brand “Eliquis”: MSN-APIXABAN
[165] Schedule 5, entry for Cefuroxime
insert as the first entry in the column headed “Brand”: ARX-Cefuroxime
[166] Schedule 5, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4
omit from the column headed “Brand”: Nepexto
[167] Schedule 5, entry for Gabapentin [GRP-1081]
(a) insert as the first entry in the column headed “Brand”: APX-GABAPENTIN
(b) omit from the column headed “Brand”: Gabapentin APOTEX
[168] Schedule 5, entry for Guanfacine [GRP-31050]
insert as the first entry in the column headed “Brand”: Guanfacine MHC
[169] Schedule 5, entry for Guanfacine [GRP-31052]
insert as the first entry in the column headed “Brand”: Guanfacine MHC
[170] Schedule 5, entry for Guanfacine [GRP-31054]
insert as the first entry in the column headed “Brand”: Guanfacine MHC
[171] Schedule 5, entry for Guanfacine [GRP-31056]
insert as the first entry in the column headed “Brand”: Guanfacine MHC
[172] Schedule 5, omit entry for Lenalidomide
[173] Schedule 5, entry for Levetiracetam [GRP-688]
omit from the column headed “Brand”: Levetiracetam Mylan
[174] Schedule 5, after entry for Nicorandil [GRP-16153]
insert:
| Nilotinib | GRP-30979 | Capsule 150 mg (as hydrochloride) | Oral | CeahaniMSN-NILOTINIBNILOTASTasigna |
| Nilotinib | GRP-30981 | Capsule 200 mg (as hydrochloride) | Oral | CeahaniMSN-NILOTINIBNILOTASTasigna |
[175] Schedule 5, entry for Olmesartan [GRP-21125]
omit from the column headed “Brand”: APX-Olmesartan
[176] Schedule 5, entry for Olmesartan [GRP-21127]
omit from the column headed “Brand”: APX-Olmesartan
[177] Schedule 5, entry for Olmesartan with hydrochlorothiazide [GRP-21129]
omit from the column headed “Brand”: APX-Olmesartan/HCTZ
[178] Schedule 5, entry for Olmesartan with hydrochlorothiazide [GRP-21131]
omit from the column headed “Brand”: APX-Olmesartan/HCTZ
[179] Schedule 5, entry for Olmesartan with hydrochlorothiazide [GRP-21133]
omit from the column headed “Brand”: APX-Olmesartan/HCTZ
[180] Schedule 5, entry for Omalizumab in the form Injection 75 mg in 0.5 mL single dose pre-filled pen
insert as the first entry in the column headed “Brand”: Omlyclo
[181] Schedule 5, entry for Omalizumab in the form Injection 150 mg in 1 mL single dose pre-filled pen
insert as the first entry in the column headed “Brand”: Omlyclo
[182] Schedule 5, entries for Oxycodone
omit:
| Oxycodone | GRP-23904 | Tablet containing oxycodone hydrochloride 5 mg | Oral | ENDONEOxycodone Viatris |
[183] Schedule 5, entry for Risedronic acid [GRP-6695]
insert in the column headed “Brand” after entry for the brand “APO-Risedronate”: Risedronate Way
[184] Schedule 5, entries for Salbutamol
omit:
| Salbutamol | GRP-921 | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 | Inhalation | Ventolin Nebules |
| Salbutamol | GRP-921 | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 | Inhalation | Salbutamol Cipla |
[185] Schedule 5, after entry for Tobramycin
insert:
| Tocilizumab | GRP-25598 | Concentrate for injection 200 mg in 10 mL | Injection | ActemraAvtozma |
| Tocilizumab | GRP-25599 | Concentrate for injection 400 mg in 20 mL | Injection | ActemraAvtozma |
| Tocilizumab | GRP-25600 | Concentrate for injection 80 mg in 4 mL | Injection | ActemraAvtozma |
| Tocilizumab | GRP-31057 | Injection 162 mg in 0.9 mL single use pre-filled pen | Injection | Actemra ACTPenAvtozma |
| Tocilizumab | GRP-31058 | Injection 162 mg in 0.9 mL single use pre-filled syringe | Injection | Actemra Subcutaneous InjectionAvtozma |
[186] Schedule 5, entry for Varenicline [GRP-26236]
insert in the column headed “Brand” after entry for the brand “Varenicline Viatris”: VASSIX
[187] Schedule 5, entry for Varenicline [GRP-27902]
insert in the column headed “Brand” after entry for the brand “Varenicline Viatris”: VASSIX
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.