Schedule 1—Amendments
National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024)
[1] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Adalicip; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[2] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[3] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[4] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[5] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[6] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[7] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Humira; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[8] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[9] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled syringe [Brand: Yuflyma; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[10] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Abrilada; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[11] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[12] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[13] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[14] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Abrilada; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[15] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Amgevita; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[16] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hadlima; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[17] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Brand: Hyrimoz; Maximum Quantity: 2; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C11861
(b) insert in numerical order in the column headed “Circumstances”: C16414
(c) omit from the column headed “Purposes”: P11861
(d) insert in numerical order in the column headed “Purposes”: P16414
[18] Schedule 1, Part 1, omit entry for Adefovir
[19] Schedule 1, Part 1, entries for Afatinib
(a) omit from the column headed “Circumstances” (all instances): C4473
(b) insert in numerical order in the column headed “Circumstances” (all instances): C16404
[20] Schedule 1, Part 1, after entry for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides in the form Oral powder 400 g (Alfamino Junior)
insert:
Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides | Oral powder 400 g (Essential Care Jr) | Oral | Essential Care Jr | QH | MP NP | C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 C5945 C5974 | | 8 | 5 | | 1 | | |
[21] Schedule 1, Part 1, entries for Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides
omit:
Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides | Oral powder 800 g (Essential Care Jr) | Oral | Essential Care Jr | QH | MP NP | C4305 C4312 C4323 C4330 C4337 C4338 C4339 C4345 C4352 C4415 C5945 C5974 | | 4 | 5 | | 1 | | |
[22] Schedule 1, Part 1, after entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg [Brand: ENTRIP]
insert:
Amivantamab | Solution concentrate for I.V. infusion 350 mg in 7 mL | Injection | Rybrevant | JC | MP | C16402 C16472 | | See Note 3 | See Note 3 | | 1 | | D(100) |
[23] Schedule 1, Part 1, after entry for Arginine with carbohydrate in the form Sachets of oral powder 7.6 g containing 5 g arginine, 30 (Arginine 5000)
insert:
Aripiprazole | I.M. injection (modified release) 720 mg (as monohydrate) in 2.4 mL pre-filled syringe | Injection | Abilify Asimtufii | LU | MP NP | C16456 | | 1 | 2 | | 1 | | |
Aripiprazole | I.M. injection (modified release) 960 mg (as monohydrate) in 3.2 mL pre-filled syringe | Injection | Abilify Asimtufii | LU | MP NP | C16456 | | 1 | 2 | | 1 | | |
[24] Schedule 1, Part 1, after entry for Azacitidine in the form Powder for injection 100 mg [Brand: Azacitidine Sandoz]
insert:
Azacitidine | Powder for injection 100 mg | Injection | Azacitidine SXP | XN | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 1 | | PB(100) |
[25] Schedule 1, Part 1, after entry for Bosentan in the form Tablet 125 mg (as monohydrate) [Brand: Bosentan RBX]
insert:
Bosentan | Tablet 125 mg (as monohydrate) | Oral | Bosentan Viatris | AL | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 60 | | D(100) |
[26] Schedule 1, Part 1, entries for Calcipotriol with betamethasone in the form Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g [Brand: Klarvanta]
omit from the column headed “Responsible Person” (all instances): LG substitute (all instances): XT
[27] Schedule 1, Part 1, entries for Capecitabine
omit:
Capecitabine | Tablet 500 mg | Oral | Capecitabine Alphapharm | AF | MP | | | 120 | 2 | | 120 | | |
[28] Schedule 1, Part 1, omit entries for Cefotaxime
[29] Schedule 1, Part 1, after entry for Clindamycin in the form Capsule 150 mg (as hydrochloride) [Brand: Dalacin C; Maximum Quantity: 48; Number of Repeats: 1]
insert:
Clobetasol | Cream containing clobetasol propionate 500 micrograms per g, 30 g | Application | Xobet | XT | MP | C16464 | | 1 | 0 | | 1 | | |
Clobetasol | Ointment containing clobetasol propionate 500 micrograms per g, 30 g | Application | Xobet | XT | MP | C16464 | | 1 | 0 | | 1 | | |
[30] Schedule 1, Part 1, entry for Dabrafenib in the form Capsule 50 mg (as mesilate) [Maximum Quantity: 240; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C16360
(b) omit from the column headed “Circumstances”: C16389
(c) insert in numerical order in the column headed “Circumstances”: C16426 C16428
(d) omit from the column headed “Purposes”: P16360
(e) omit from the column headed “Purposes”: P16389
(f) insert in numerical order in the column headed “Purposes”: P16426 P16428
[31] Schedule 1, Part 1, entry for Dabrafenib in the form Capsule 75 mg (as mesilate) [Maximum Quantity: 120; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C16360
(b) omit from the column headed “Circumstances”: C16389
(c) insert in numerical order in the column headed “Circumstances”: C16426 C16428
(d) omit from the column headed “Purposes”: P16360
(e) omit from the column headed “Purposes”: P16389
(f) insert in numerical order in the column headed “Purposes”: P16426 P16428
[32] Schedule 1, Part 1, entry for Dabrafenib in the form Tablet (dispersible) 10 mg (as mesilate) [Maximum Quantity: 840; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C16360
(b) omit from the column headed “Circumstances”: C16389
(c) insert in numerical order in the column headed “Circumstances”: C16426 C16428
(d) omit from the column headed “Purposes”: P16360
(e) omit from the column headed “Purposes”: P16389
(f) insert in numerical order in the column headed “Purposes”: P16426 P16428
[33] Schedule 1, Part 1, entries for Dostarlimab
substitute:
Dostarlimab | Solution concentrate for I.V. infusion 500 mg in 10 mL | Injection | Jemperli | GK | MP | C15163 C15205 | | See Note 3 | See Note 3 | | 1 | | D(100) |
[34] Schedule 1, Part 1, after entry for Doxycycline in the form Tablet 100 mg (as monohydrate) [Maximum Quantity: 56; Number of Repeats: 2]
insert:
Drospirenone | Pack containing 24 tablets 4 mg and 4 inert tablets | Oral | Slinda | HB | MP MW NP | | | 4 | 2 | | 4 | | |
[35] Schedule 1, Part 1, entries for Eculizumab
substitute:
Eculizumab | Solution concentrate for I.V. infusion 300 mg in 30 mL | Injection | Soliris | XI | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 1 | | D(100) |
[36] Schedule 1, Part 1, after entry for Eculizumab
insert:
Edaravone | Solution concentrate for I.V. infusion 30 mg in 20 mL | Injection | Radicava | TB | MP | C16479 | P16479 | 20 | 2 | | 10 | | D(100) |
Edaravone | Solution concentrate for I.V. infusion 30 mg in 20 mL | Injection | Radicava | TB | MP | C16435 | P16435 | 28 | 0 | | 10 | | D(100) |
[37] Schedule 1, Part 1, after entry for Enzalutamide in the form Capsule 40 mg [Maximum Quantity: 112; Number of Repeats: 5]
insert:
Epcoritamab | Solution concentrate for subcutaneous injection 4 mg in 0.8 mL | Injection | Epkinly | VE | MP | C16405 | | 1 | 1 | | 1 | | |
Epcoritamab | Solution for subcutaneous injection 48 mg in 0.8 mL | Injection | Epkinly | VE | MP | C16465 C16466 | | 1 | 9 | | 1 | | |
[38] Schedule 1, Part 1, entries for Erlotinib
(a) omit from the column headed “Circumstances” (all instances): C4473
(b) insert in numerical order in the column headed “Circumstances” (all instances): C16404
[39] Schedule 1, Part 1, after entry for Escitalopram in the form Tablet 20 mg (as oxalate) [Brand: LoxaLate; Maximum Quantity: 56; Number of Repeats: 2]
insert:
Esketamine | Nasal spray device 28 mg in 2 actuations | Nasal | Spravato | JC | MP | C16421 C16460 | P16421 P16460 | 4 | 5 | | 1 | | |
Esketamine | Nasal spray device 28 mg in 2 actuations | Nasal | Spravato | JC | MP | C16477 | P16477 | 8 | 0 | | 1 | | |
Esketamine | Nasal spray device 28 mg in 2 actuations | Nasal | Spravato | JC | MP | C16438 C16470 | P16438 P16470 | 8 | 5 | | 2 | | |
Esketamine | Nasal spray device 28 mg in 2 actuations | Nasal | Spravato | JC | MP | C16416 C16419 | P16416 P16419 | 12 | 5 | | 3 | | |
Esketamine | Nasal spray device 28 mg in 2 actuations | Nasal | Spravato | JC | MP | C16422 | P16422 | 16 | 0 | | 2 | | |
Esketamine | Nasal spray device 28 mg in 2 actuations | Nasal | Spravato | JC | MP | C16454 | P16454 | 24 | 0 | | 3 | | |
[40] Schedule 1, Part 1, after entry for Ezetimibe in the form Tablet 10 mg [Brand: APO-Ezetimibe; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Ezetimibe | Tablet 10 mg | Oral | ARX-EZETIMIBE | XT | MP NP | | | 30 | 5 | | 30 | | |
Ezetimibe | Tablet 10 mg | Oral | ARX-EZETIMIBE | XT | MP NP | | P14238 | 60 | 5 | | 30 | | |
[41] Schedule 1, Part 1, entries for Faricimab
substitute:
Faricimab | Solution for intravitreal injection 21 mg in 0.175 mL (120 mg per mL) pre-filled syringe | Injection | Vabysmo | RO | MP | C13406 C16482 | P13406 P16482 | 1 | 2 | | 1 | | |
Faricimab | Solution for intravitreal injection 21 mg in 0.175 mL (120 mg per mL) pre-filled syringe | Injection | Vabysmo | RO | MP | C13402 C16442 | P13402 P16442 | 1 | 5 | | 1 | | |
Faricimab | Solution for intravitreal injection 28.8 mg in 0.24 mL (120 mg per mL) | Injection | Vabysmo | RO | MP | C13336 C13387 C13406 C16309 C16319 C16482 | P13336 P13387 P13406 P16309 P16319 P16482 | 1 | 2 | | 1 | | |
Faricimab | Solution for intravitreal injection 28.8 mg in 0.24 mL (120 mg per mL) | Injection | Vabysmo | RO | MP | C13402 C16442 | P13402 P16442 | 1 | 5 | | 1 | | |
[42] Schedule 1, Part 1, after entry for Felodipine in the form Tablet 10 mg (extended release) [Brand: Plendil ER; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Fenfluramine | Oral solution 2.2 mg (as hydrochloride) per mL, 360 mL | Oral | Fintepla | UC | MP | C16473 | | 1 | 5 | | 1 | | |
[43] Schedule 1, Part 1, entries for Follitropin beta in the form Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge
omit:
Follitropin beta | Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge | Injection | Recagon | OV | MP | C5027 | P5027 | 2 | 0 | | 1 | | |
Follitropin beta | Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge | Injection | Recagon | OV | MP | C6257 C6321 | P6257 P6321 | 3 | 5 | | 1 | | |
[44] Schedule 1, Part 1, entries for Follitropin beta in the form Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge
omit:
Follitropin beta | Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge | Injection | Recagon | OV | MP | C6257 C6321 | P6257 P6321 | 2 | 5 | | 1 | | |
Follitropin beta | Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge | Injection | Recagon | OV | MP | C5027 | P5027 | 5 | 0 | | 1 | | |
[45] Schedule 1, Part 1, entries for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide) [Brand: Reminyl]
omit from the column headed “Responsible Person” (all instances): JC substitute (all instances): IX
[46] Schedule 1, Part 1, after entry for Ganirelix [Brand: ARX Ganirelix; Pack Quantity: 5]
insert:
Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe | Injection | Ganirelix Lupin | GQ | MP | C5046 | | 10 | 0 | | 1 | | D(100) |
Ganirelix | Injection 250 micrograms (as acetate) in 0.5 mL pre-filled syringe | Injection | Ganirelix Lupin | GQ | MP | C5046 | | 10 | 0 | | 5 | | D(100) |
[47] Schedule 1, Part 1, entry for Gefitinib
(a) omit from the column headed “Circumstances”: C4473
(b) insert in numerical order in the column headed “Circumstances”: C16404
[48] Schedule 1, Part 1, omit entry for Gentamicin
[49] Schedule 1, Part 1, after entry for Glycomacropeptide and essential amino acids with vitamins and minerals in the form Oral liquid 250 mL, 30 (Tylactin RTD)
insert:
Glycomacropeptide and essential amino acids with vitamins and minerals | Sachets containing oral powder 15 g, 30 (PKU Build 10) | Oral | PKU Build 10 | QH | MP NP | C4295 | | 4 | 5 | | 1 | | |
[50] Schedule 1, Part 1, entries for Glycomacropeptide and essential amino acids with vitamins and minerals
omit:
Glycomacropeptide and essential amino acids with vitamins and minerals | Sachets containing oral powder 16 g, 60 (PKU Build 10) | Oral | PKU Build 10 | QH | MP NP | C4295 | | 2 | 5 | | 1 | | |
[51] Schedule 1, Part 1, entries for Lercanidipine in the form Tablet containing lercanidipine hydrochloride 20 mg
omit:
Lercanidipine | Tablet containing lercanidipine hydrochloride 20 mg | Oral | Lercanidipine APOTEX | GX | MP NP | | | 28 | 5 | | 28 | | |
Lercanidipine | Tablet containing lercanidipine hydrochloride 20 mg | Oral | Lercanidipine APOTEX | GX | MP NP | | P14238 | 56 | 5 | | 28 | | |
[52] Schedule 1, Part 1, after entry for Levodopa with carbidopa in the form Tablet 100 mg-25 mg (as monohydrate) [Brand: Kinson; Maximum Quantity: 200; Number of Repeats: 5]
insert:
Levodopa with carbidopa | Tablet 100 mg-25 mg (as monohydrate) | Oral | ORIDOPA 100/25 | OX | MP NP | | | 100 | 5 | | 100 | | |
Levodopa with carbidopa | Tablet 100 mg-25 mg (as monohydrate) | Oral | ORIDOPA 100/25 | OX | MP NP | | P14238 | 200 | 5 | | 100 | | |
[53] Schedule 1, Part 1, after entry for Macitentan
insert:
Macitentan with tadalafil | Tablet containing 10 mg macitentan with 40 mg tadalafil | Oral | Opsynvi | JC | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 30 | | D(100) |
[54] Schedule 1, Part 1, entry for Mavacamten in the form Capsule 2.5 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C15189 C15210 substitute: C16425
(b) omit from the column headed “Purposes”: P15189 P15210 substitute: P16425
[55] Schedule 1, Part 1, entry for Mavacamten in the form Capsule 5 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C15189 C15210 substitute: C16425
(b) omit from the column headed “Purposes”: P15189 P15210 substitute: P16425
[56] Schedule 1, Part 1, entry for Mavacamten in the form Capsule 10 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C15189 C15210 substitute: C16425
(b) omit from the column headed “Purposes”: P15189 P15210 substitute: P16425
[57] Schedule 1, Part 1, entry for Mavacamten in the form Capsule 15 mg [Maximum Quantity: 28; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C15189 C15210 substitute: C16425
(b) omit from the column headed “Purposes”: P15189 P15210 substitute: P16425
[58] Schedule 1, Part 1, entries for Methylprednisolone
omit:
Methylprednisolone | Powder for injection 40 mg (as sodium succinate) with diluent | Injection | Solu-Medrol | PF | MP NP | | | 5 | 0 | | 1 | | |
[59] Schedule 1, Part 1, entries for Methylprednisolone in the form Powder for injection 1 g (as sodium succinate)
omit:
Methylprednisolone | Powder for injection 1 g (as sodium succinate) | Injection | Methylpred | AL | MP NP | | | 1 | 0 | | 1 | | |
[60] Schedule 1, Part 1, entries for Morphine
omit:
Morphine | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) | WZ | MP NP | C10764 C10770 C10777 | P10764 P10770 P10777 | 200 | 0 | | 200 | | |
Morphine | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) | WZ | PDP | C10859 | | 200 | 0 | | 200 | | |
Morphine | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) | WZ | MP NP | C11697 | P11697 | 400 | 1 | | 200 | | |
[61] Schedule 1, Part 1, after entry for Nebivolol in the form Tablet 5 mg (as hydrochloride) [Brand: APO-Nebivolol; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Nebivolol | Tablet 5 mg (as hydrochloride) | Oral | Nebaloc | CR | MP NP | C5324 | P5324 | 28 | 5 | | 28 | | |
Nebivolol | Tablet 5 mg (as hydrochloride) | Oral | Nebaloc | CR | MP NP | C14251 | P14251 | 56 | 5 | | 28 | | |
[62] Schedule 1, Part 1, after entry for Nebivolol in the form Tablet 10 mg (as hydrochloride) [Brand: APO-Nebivolol; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Nebivolol | Tablet 10 mg (as hydrochloride) | Oral | Nebaloc | CR | MP NP | C5324 | P5324 | 28 | 5 | | 28 | | |
Nebivolol | Tablet 10 mg (as hydrochloride) | Oral | Nebaloc | CR | MP NP | C14251 | P14251 | 56 | 5 | | 28 | | |
[63] Schedule 1, Part 1, entry for Osimertinib in the form Tablet 80 mg
(a) omit from the column headed “Circumstances”: C15299
(b) insert in numerical order in the column headed “Circumstances”: C16444
[64] Schedule 1, Part 1, after entry for Paracetamol in the form Tablet 665 mg (modified release) [Brand: APOHEALTH Osteo Relief Paracetamol 665 mg; Maximum Quantity: 192; Number of Repeats: 5]
insert:
Paracetamol | Tablet 665 mg (modified release) | Oral | Chemists' Own Osteo Relief Paracetamol | RF | MP NP | C6225 | | 192 | 3 | | 96 | | |
Paracetamol | Tablet 665 mg (modified release) | Oral | Chemists' Own Osteo Relief Paracetamol | RF | MP NP | C6280 | | 192 | 5 | | 96 | | |
[65] Schedule 1, Part 1, entries for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
Perindopril | Tablet containing perindopril erbumine 2 mg | Oral | Indosyl Mono 2 | RW | MP NP | | | 30 | 5 | | 30 | | |
Perindopril | Tablet containing perindopril erbumine 2 mg | Oral | Indosyl Mono 2 | RW | MP NP | | P14238 | 60 | 5 | | 30 | | |
[66] Schedule 1, Part 1, entries for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit:
Perindopril | Tablet containing perindopril erbumine 4 mg | Oral | Indosyl Mono 4 | RW | MP NP | | | 30 | 5 | | 30 | | |
Perindopril | Tablet containing perindopril erbumine 4 mg | Oral | Indosyl Mono 4 | RW | MP NP | | P14238 | 60 | 5 | | 30 | | |
[67] Schedule 1, Part 1, entries for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit:
Perindopril | Tablet containing perindopril erbumine 8 mg | Oral | Indosyl Mono 8 | RW | MP NP | | | 30 | 5 | | 30 | | |
Perindopril | Tablet containing perindopril erbumine 8 mg | Oral | Indosyl Mono 8 | RW | MP NP | | P14238 | 60 | 5 | | 30 | | |
[68] Schedule 1, Part 1, entries for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
omit:
Perindopril with indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg | Oral | Indosyl Combi 4/1.25 | RW | MP NP | C4375 | P4375 | 30 | 5 | | 30 | | |
Perindopril with indapamide | Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg | Oral | Indosyl Combi 4/1.25 | RW | MP NP | C14267 | P14267 | 60 | 5 | | 30 | | |
[69] Schedule 1, Part 1, entries for Polyethylene glycol 400 with propylene glycol in the form Eye drops 4 mg-3 mg per mL, 15 mL
omit:
Polyethylene glycol 400 with propylene glycol | Eye drops 4 mg-3 mg per mL, 15 mL | Application to the eye | Optix | PP | MP NP AO | C15560 | P15560 | 1 | 5 | | 1 | | |
Polyethylene glycol 400 with propylene glycol | Eye drops 4 mg-3 mg per mL, 15 mL | Application to the eye | Optix | PP | MP NP AO | C15556 | P15556 | 2 | 5 | | 1 | | |
[70] Schedule 1, Part 1, after entry for Pramipexole in the form Tablet containing pramipexole dihydrochloride monohydrate 1 mg [Brand: Simpral; Maximum Quantity: 200; Number of Repeats: 5]
insert:
Prasugrel | Tablet 5 mg | Oral | Prasugrel Lupin | GQ | MP NP | C16443 | | 28 | 5 | | 28 | | |
Prasugrel | Tablet 10 mg | Oral | Prasugrel Lupin | GQ | MP NP | C16443 | | 28 | 5 | | 28 | | |
[71] Schedule 1, Part 1, omit entry for Praziquantel
[72] Schedule 1, Part 1, after entry for Pravastatin in the form Tablet containing pravastatin sodium 80 mg [Brand: Pravachol; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Prazosin | Capsule 1 mg (as hydrochloride) (S19A) | Oral | Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) | DZ | MP NP | | | 100 | 5 | | 100 | | |
Prazosin | Capsule 1 mg (as hydrochloride) (S19A) | Oral | Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) | DZ | MP NP | | P14238 | 200 | 5 | | 100 | | |
[73] Schedule 1, Part 1, after entry for Reboxetine [Maximum Quantity: 120; Number of Repeats: 2]
insert:
Relugolix with estradiol and with norethisterone | Tablet containing relugolix 40 mg with estradiol (as hemihydrate) 1 mg and with norethisterone acetate 500 micrograms | Oral | Ryeqo | FX | MP | C16429 C16430 | | 28 | 5 | | 28 | | |
[74] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 10 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 10 mg | Oral | RIVAXIB | MQ | MP NP | C4402 | P4402 | 30 | 0 | | 30 | | |
Rivaroxaban | Tablet 10 mg | Oral | RIVAXIB | MQ | MP NP | C4132 | P4132 | 30 | 5 | | 30 | | |
Rivaroxaban | Tablet 10 mg | Oral | RIVAXIB | MQ | MP NP | C14300 | P14300 | 60 | 5 | | 30 | | |
[75] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 15 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 15 mg | Oral | RIVAXIB | MQ | MP NP | C4269 | P4269 | 28 | 5 | | 28 | | |
Rivaroxaban | Tablet 15 mg | Oral | RIVAXIB | MQ | MP NP | C4098 C5098 | P4098 P5098 | 42 | 0 | | 42 | | |
Rivaroxaban | Tablet 15 mg | Oral | RIVAXIB | MQ | MP NP | C14301 | P14301 | 56 | 5 | | 28 | | |
[76] Schedule 1, Part 1, after entry for Rivaroxaban in the form Tablet 20 mg [Brand: Rivaroxaban-Teva; Maximum Quantity: 56; Number of Repeats: 5]
insert:
Rivaroxaban | Tablet 20 mg | Oral | RIVAXIB | MQ | MP NP | C4099 C4132 C4268 C4269 | P4099 P4132 P4268 P4269 | 28 | 5 | | 28 | | |
Rivaroxaban | Tablet 20 mg | Oral | RIVAXIB | MQ | MP NP | C14264 C14300 C14301 C14318 | P14264 P14300 P14301 P14318 | 56 | 5 | | 28 | | |
[77] Schedule 1, Part 1, entries for Siponimod in the form Tablet 250 micrograms (as hemifumarate)
substitute:
Siponimod | Tablet 250 micrograms (as hemifumarate) | Oral | Mayzent | NV | MP NP | C16303 C16347 | | 12 | 0 | | 12 | | |
[78] Schedule 1, Part 1, entries for Tenecteplase
omit:
Tenecteplase | Powder for injection 50 mg with solvent (s19A) | Injection | TNKase (Canada) | QY | MP NP | C5783 | | 1 | 0 | | 1 | | |
Tenecteplase | Powder for injection 50 mg with solvent (s19A) | Injection | TNKase (Canada) Medsurge Healthcare Pty Ltd | DZ | MP NP | C5783 | | 1 | 0 | | 1 | | |
[79] Schedule 1, Part 1, after entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg [Brand: CIPLA TENOFOVIR + EMTRICITABINE 300/200; Maximum Quantity: 60; Number of Repeats: 5]
insert:
Tenofovir with emtricitabine | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg | Oral | TENOFOVIR/EMTRICITABINE 300/200 APX | XW | MP NP | C11143 | P11143 | 30 | 2 | | 30 | | |
Tenofovir with emtricitabine | Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg | Oral | TENOFOVIR/EMTRICITABINE 300/200 APX | XW | MP NP | C6985 C6986 | P6985 P6986 | 60 | 5 | | 30 | | C(100) |
[80] Schedule 1, Part 1, entries for Tobramycin
omit:
Tobramycin | Eye drops 3 mg per mL, 5 mL | Application to the eye | Tobrex | NV | MP | C5451 C5483 C5499 | | 1 | 2 | | 1 | | |
Tobramycin | Eye drops 3 mg per mL, 5 mL | Application to the eye | Tobrex | NV | AO | C5476 C5477 | | 1 | 2 | | 1 | | |
Tobramycin | Eye ointment 3 mg per g, 3.5 g | Application to the eye | Tobrex | NV | MP | C5451 C5483 C5499 | | 1 | 0 | | 1 | | |
Tobramycin | Eye ointment 3 mg per g, 3.5 g | Application to the eye | Tobrex | NV | AO | C5476 C5477 | | 1 | 0 | | 1 | | |
[81] Schedule 1, Part 1, after entry for Tranexamic acid [Brand: Tranexamic Acid Lupin]
insert:
Tranexamic acid | Tablet 500 mg | Oral | Tranexamic Acid Waymade | IX | MP NP | | | 100 | 2 | | 100 | | |
[82] Schedule 1, Part 1, after entry for Vosoritide in the form Powder for injection 1.2 mg with diluent
insert:
Vutrisiran | Injection 25 mg (as sodium) in 0.5 mL pre-filled syringe | Injection | Amvuttra | WM | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | | 1 | | D(100) |
[83] Schedule 1, Part 2, after entry for Adefovir
insert:
Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides | Oral powder 800 g (Essential Care Jr) | Oral | Essential Care Jr | QH | 1 | | |
[84] Schedule 1, Part 2, after entry for Glyceryl trinitrate
insert:
Glycomacropeptide and essential amino acids with vitamins and minerals | Sachets containing oral powder 16 g, 60 (PKU Build 10) | Oral | PKU Build 10 | QH | 1 | | |
[85] Schedule 3
omit:
LG | Leo Pharma Pty Ltd | 72 147 880 617 |
[86] Schedule 3
omit:
OV | Organon Pharma Pty Ltd | 54 637 107 512 |
[87] Schedule 4, Part 1, omit entry for Circumstances Code “C4473”
[88] Schedule 4, Part 1, omit entry for Circumstances Code “C4490”
[89] Schedule 4, Part 1, omit entry for Circumstances Code “C4510”
[90] Schedule 4, Part 1, omit entry for Circumstances Code “C5451”
[91] Schedule 4, Part 1, omit entry for Circumstances Code “C5476”
[92] Schedule 4, Part 1, omit entry for Circumstances Code “C5477”
[93] Schedule 4, Part 1, omit entry for Circumstances Code “C5483”
[94] Schedule 4, Part 1, omit entry for Circumstances Code “C5499”
[95] Schedule 4, Part 1, omit entry for Circumstances Code “C5659”
[96] Schedule 4, Part 1, omit entry for Circumstances Code “C5905”
[97] Schedule 4, Part 1, omit entry for Circumstances Code “C11861”
[98] Schedule 4, Part 1, entry for Circumstances Code “C12821”
omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: Compliance with Authority Required procedures
substitute: Compliance with Written Authority Required procedures
[99] Schedule 4, Part 1, entry for Circumstances Code “C13388”
omit from the column headed “Listed Drug”: Faricimab
[100] Schedule 4, Part 1, entry for Circumstances Code “C13418”
omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: Compliance with Authority Required procedures
substitute: Compliance with Written Authority Required procedures
[101] Schedule 4, Part 1, entry for Circumstances Code “C13424”
omit from the column headed “Listed Drug”: Faricimab
[102] Schedule 4, Part 1, entry for Circumstances Code “C14008”
omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: Compliance with Authority Required procedures
substitute: Compliance with Written Authority Required procedures
[103] Schedule 4, Part 1, omit entry for Circumstances Code “C15189”
[104] Schedule 4, Part 1, omit entry for Circumstances Code “C15196”
[105] Schedule 4, Part 1, omit entry for Circumstances Code “C15210”
[106] Schedule 4, Part 1, omit entry for Circumstances Code “C15299”
[107] Schedule 4, Part 1, entry for Circumstances Code “C15964”
omit from the column headed “Listed Drug”: Cefotaxime
[108] Schedule 4, Part 1, entry for Circumstances Code “C16029”
omit from the column headed “Listed Drug”: Cefotaxime
[109] Schedule 4, Part 1, entry for Circumstances Code “C16030”
omit from the column headed “Listed Drug”: Cefotaxime
[110] Schedule 4, Part 1, omit entry for Circumstances Code “C16360”
[111] Schedule 4, Part 1, omit entry for Circumstances Code “C16389”
[112] Schedule 4, Part 1, after entry for Circumstances Code “C16396”
insert:
C16402 | P16402 | CN16402 | Amivantamab | Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. | Compliance with Authority Required procedures |
C16404 | P16404 | CN16404 | Afatinib Erlotinib Gefitinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation. | Compliance with Authority Required procedures |
C16405 | P16405 | CN16405 | Epcoritamab | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Induction treatment The condition must have relapsed, or be refractory to, at least two prior systemic therapies; AND Patient must have a WHO performance status of no higher than 2; AND Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; or Patient must be currently unable to receive treatment with CAR-T cell therapy for this condition; AND Patient must not be eligible for stem cell transplantation; AND The treatment must be discontinued in patients who experience disease progression whilst on treatment. Prior systemic therapy may include autologous stem cell transplant. Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency. | Compliance with Authority Required procedures |
C16414 | P16414 | CN16414 | Adalimumab | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. An adequate response to treatment is defined as: an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; 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 major active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C16416 | P16416 | CN16416 | Esketamine | Treatment resistant major depression Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this indication prior to 1 May 2025; AND The condition must have been inadequately responsive to at least two anti-depressant drug therapies prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records). Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The listed quantity of 12 units of nasal spray is intended for a dosage of 84 mg per treatment administration for patients transitioning from non-PBS to PBS-subsidised treatment. | Compliance with Authority Required procedures |
C16419 | P16419 | CN16419 | Esketamine | Treatment resistant major depression Non-induction treatment The treatment must be to continue existing PBS-subsidised treatment for this indication; AND The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records). Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The listed quantity of 12 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the non-induction treatment setting. | Compliance with Authority Required procedures |
C16421 | P16421 | CN16421 | Esketamine | Treatment resistant major depression Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this indication prior to 1 May 2025; AND The condition must have been inadequately responsive to at least two anti-depressant drug therapies prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records). Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The listed quantity of 4 units of nasal spray is intended for a dosage of 28 mg per treatment administration for patients transitioning from non-PBS to PBS-subsidised treatment. | Compliance with Authority Required procedures |
C16422 | P16422 | CN16422 | Esketamine | Treatment resistant major depression Induction treatment The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies. Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The following must apply if reinitiating treatment: (i) at least four-week gap from last treatment course to reinitiation of treatment; and (ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and (iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression. The listed quantity of 16 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the induction treatment setting. | Compliance with Authority Required procedures |
C16425 | P16425 | CN16425 | Mavacamten | Symptomatic obstructive hypertrophic cardiomyopathy Subsequent continuing treatment - Maintenance treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must be undergoing concomitant treatment with at least one of: (i) a beta-blocker (ii) non-dihydropyridine calcium channel blocker, unless at least one of the following is present: (a) a contraindication to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy as listed in the TGA approved Product Information; (b) an intolerance to beta-blocker and/or non-dihydropyridine calcium channel blocker therapy; AND Patient must have a current left ventricular ejection fraction (LVEF) of no less than 50%; AND Patient must have demonstrated a response after at least 6 months on the optimal dose of mavacamten treatment defined as an improvement in at least one of the following: (i) symptoms, (ii) quality of life, (iii) exercise capacity, (iv) peak left ventricular outflow tract (LVOT) gradient. Must be treated by a cardiologist. or Must be treated by a consultant physician with experience in the management of hypertrophic cardiomyopathy. | Compliance with Authority Required procedures |
C16426 | P16426 | CN16426 | Dabrafenib | Paediatric low grade glioma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2025; AND The condition must have been World Health Organisation (WHO) grade 1 or 2 prior to commencing treatment with this therapy; AND The condition must have progressed following surgical excision prior to commencing treatment with this therapy; or The condition must not have been amenable to surgery with risk of neurological impairment following progression prior to commencing treatment with this therapy; AND The condition must be positive for a BRAF V600 mutation; AND Patient must have had either a: (i) Karnofsky, (ii) Lansky performance score of at least 50% prior to commencing treatment with this therapy; AND Patient must have either: (i) stable, (ii) responding disease based on the Response Assessment in Neuro-Oncology (RANO) criteria; AND Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition. Patient must have been aged between 12 months to 18 years at diagnosis. | Compliance with Authority Required procedures |
C16428 | P16428 | CN16428 | Dabrafenib | Paediatric high grade glioma Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2025; AND The condition must have been World Health Organisation (WHO) grade 3 or 4 prior to commencing treatment with this therapy; AND Patient must have relapsed or progressed following frontline therapy prior to commencing treatment with this therapy; or Patient must have failed to respond to frontline therapy prior to commencing treatment with this therapy; AND The condition must be positive for a BRAF V600 mutation; AND Patient must have had either a: (i) Karnofsky, (ii) Lansky performance score of at least 50% prior to commencing treatment with this therapy; AND Patient must have either: (i) stable, (ii) responding disease based on the Response Assessment in Neuro-Oncology (RANO) criteria; AND Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition. Patient must have been aged between 12 months to 18 years at diagnosis. | Compliance with Authority Required procedures |
C16429 | P16429 | CN16429 | Relugolix with estradiol and with norethisterone | Endometriosis Initial treatment Ryeqo should not be used interchangeably with other GnRH agonists and/or hormonal contraceptives brands due to differences in dose and schedule of treatment. Patient must have experienced moderate to severe pain associated with endometriosis; AND The condition must be visually proven; AND Patient must have received an inadequate response to, or be intolerant to, previous first line therapies for this condition, including at least one of the following: (i) hormonal contraceptives, (ii) analgesics; AND Patient must not have undergone surgery for this condition in the last 3 months; or Patient must not commence this treatment until 3 months post-surgery; AND Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease. Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis. Patient must be pre-menopausal; Patient must be at least 18 years of age. Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16429 |
C16430 | P16430 | CN16430 | Relugolix with estradiol and with norethisterone | Endometriosis Continuing treatment Ryeqo should not be used interchangeably with other GnRH agonists and/or hormonal contraceptives brands due to differences in dose and schedule of treatment. Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND Patient must not have undergone surgery for this condition in the last 3 months; AND Patient must not have a history of, nor currently have any of the following: (i) osteoporosis, (ii) risk of other metabolic bone disease. Must be treated by a specialist medical practitioner with experience in the diagnosis and management of endometriosis. Patient must be pre-menopausal. The prescriber must only request for this treatment phase for the patient if ongoing treatment with this drug is likely to result in an adequate response. Details of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) for continuing treatment beyond 6 months if under 41 years of age must be documented in the patient's medical record. Assessment of bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) is recommended at baseline, after the first 52 weeks of treatment, and annually thereafter. Depending on the degree of change in BMD, the benefit and risks of Ryeqo may need to be reconsidered. Use is recommended to be limited to 24 months, with extension of therapy conditional on stability of DXA and reassessment of risk/benefit in the individual patient by the treating physician. | Compliance with Authority Required procedures - Streamlined Authority Code 16430 |
C16435 | P16435 | CN16435 | Edavarone | Amyotrophic lateral sclerosis Initial treatment The condition must be/have been diagnosed by a neurologist; AND Patient must not have had symptoms for more than 2 years prior to commencing therapy with this drug; AND Patient 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; AND Patient must not require assistance with eating or ambulation; AND Patient 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; AND Patient must not have undergone a tracheostomy; AND Patient must not have experienced respiratory failure. 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. | Compliance with Authority Required procedures |
C16438 | P16438 | CN16438 | Esketamine | Treatment resistant major depression Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this indication prior to 1 May 2025; AND The condition must have been inadequately responsive to at least two anti-depressant drug therapies prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records). Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The listed quantity of 8 units of nasal spray is intended for a dosage of 56 mg per treatment administration for patients transitioning from non-PBS to PBS-subsidised treatment. | Compliance with Authority Required procedures |
C16442 | P16442 | CN16442 | Faricimab | Diabetic macular oedema (DMO) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C16443 | P16443 | CN16443 | Prasugrel | Acute coronary syndrome (myocardial infarction or unstable angina) The treatment must be in combination with aspirin; AND Patient must have percutaneous coronary intervention planned; or Patient must have previously undergone percutaneous coronary intervention; AND Patient must not have a known history of either: (i) stroke, (ii) transient ischaemic attack; AND The treatment must be ceased if a percutaneous coronary intervention is not performed. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit. Patient must be at least 18 years of age. Patient must be treated with the recommended maintenance dose of prasugrel according to the TGA-approved Product Information. | Compliance with Authority Required procedures - Streamlined Authority Code 16443 |
C16444 | P16444 | CN16444 | Osimertinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment as first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal. Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material; Patient must not have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation. PBS-subsidised treatment with this drug is restricted to one line of therapy at any disease staging for NSCLC (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 |
C16454 | P16454 | CN16454 | Esketamine | Treatment resistant major depression Induction treatment The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies. Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The following must apply if reinitiating treatment: (i) at least four-week gap from last treatment course to reinitiation of treatment; and (ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and (iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression. The listed quantity of 24 units of nasal spray is intended for a dosage of 84 mg per treatment administration in the induction treatment setting. | Compliance with Authority Required procedures |
C16456 | P16456 | CN16456 | Aripiprazole | Schizophrenia Patient must have previously received and be stabilised on PBS-subsidised aripiprazole once-monthly injection. | Compliance with Authority Required procedures - Streamlined Authority Code 16456 |
C16460 | P16460 | CN16460 | Esketamine | Treatment resistant major depression Non-induction treatment The treatment must be to continue existing PBS-subsidised treatment for this indication; AND The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records). Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The listed quantity of 4 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the non-induction treatment setting. | Compliance with Authority Required procedures |
C16464 | P16464 | CN16464 | Clobetasol | Corticosteroid-responsive dermatoses The condition must be resistant to lower potency topical corticosteroid therapy | |
C16465 | P16465 | CN16465 | Epcoritamab | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this PBS condition prior to 1 May 2025; AND The condition must have relapsed, or be refractory to, at least two prior systemic therapies, prior to commencing treatment with this drug; AND Patient must have had a WHO performance status of no higher than 2 prior to commencing treatment with this drug for this condition; AND Patient must have previously received treatment with chimeric antigen receptor-T (CAR-T) cell therapy for this condition; or Patient must have been unable to receive treatment with CAR-T cell therapy for this condition; AND Patient must not be eligible for stem cell transplantation; AND The treatment must be discontinued in patients who experience disease progression whilst on treatment. Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats. or Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats. or Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats. Prior systemic therapy may include autologous stem cell transplant. Definition of patients unable to receive treatment with CAR-T cell therapy for this condition include geographical, psychosocial, clinical ineligibility or urgency. | Compliance with Authority Required procedures |
C16466 | P16466 | CN16466 | Epcoritamab | Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be discontinued in patients who experience disease progression whilst on treatment. Patient must be undergoing treatment with this drug administered weekly in cycles 1 to 3 - prescribe up to 9 repeats. or Patient must be undergoing treatment with this drug administered fortnightly in cycles 4 to 9 - prescribe up to 5 repeats. or Patient must be undergoing treatment with this drug administered every four weeks in cycles 10 and beyond - prescribe up to 2 repeats. | Compliance with Authority Required procedures - Streamlined Authority Code 16466 |
C16470 | P16470 | CN16470 | Esketamine | Treatment resistant major depression Non-induction treatment The treatment must be to continue existing PBS-subsidised treatment for this indication; AND The treatment must not exceed each of: (i) an administered dose beyond 84 mg, (ii) a quantity of drug, after accounting for repeat prescriptions plus different pack sizes where prescribed, that would exceed a quantity sufficient to treat the patient for 24 weeks; AND Patient must have demonstrated adequate response to treatment with esketamine after the 4-week induction and every 6 months thereafter as evaluated by a structured clinical rating scale (evidence of scores and justification of demonstration of response must be retained in the patient's medical records). Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The listed quantity of 8 units of nasal spray is intended for a dosage of 56 mg per treatment administration in the non-induction treatment setting. | Compliance with Authority Required procedures |
C16472 | P16472 | CN16472 | Amivantamab | Stage IIIB/ IIIC (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) exon 20 insertion mutation; AND Patient must have/have had a WHO performance status of no greater than 2 at treatment initiation with this drug for this condition; AND Patient must not have previously received this drug for this condition; OR Patient must be each of: (i) currently receiving non-PBS-subsidised supply for this drug for this PBS indication, (ii) free of disease progression since commencing non-PBS-subsidised supply; AND The treatment must be/have been in combination with platinum-based chemotherapy (PBC) where the patient has not previously received systemic therapy for this condition in the metastatic setting, (i.e. used in combination with PBC in the first line setting); OR The treatment must be the sole PBS-subsidised therapy where the condition has progressed following treatment with platinum-based chemotherapy, (i.e. used as monotherapy in the second line setting). | Compliance with Authority Required procedures |
C16473 | P16473 | CN16473 | Fenfluramine | Severe myoclonic epilepsy in infancy (Dravet syndrome) Patient must have (if initiating) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; or Patient must have had (if continuing) generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs. Must be treated by a neurologist if treatment is being initiated. or Must be treated by a neurologist if treatment is being continued or re-initiated. or Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued. or Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued. | Compliance with Authority Required procedures |
C16477 | P16477 | CN16477 | Esketamine | Treatment resistant major depression Induction treatment The condition must have been inadequately responsive to at least two oral anti-depressant drug therapies. Must be treated by a psychiatrist, where prescribing must also be completed by the treating psychiatrist; AND Patient must be undergoing supervision at an accredited treatment centre for the administration of esketamine. The following must apply if reinitiating treatment: (i) at least four-week gap from last treatment course to reinitiation of treatment; and (ii) evidence, documented in the patient's medical record using a structured rating scale, of significant clinical therapeutic benefit of the prior course of treatment with esketamine; and (iii) evidence, documented in the patient's medical record using a structured rating scale, of a relapse in depression. The listed quantity of 8 units of nasal spray is intended for a dosage of 28 mg per treatment administration in the induction treatment setting. | Compliance with Authority Required procedures |
C16479 | P16479 | CN16479 | Edaravone | Amyotrophic lateral sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have undergone a tracheostomy; AND Patient must not have experienced respiratory failure. | Compliance with Authority Required procedures |
C16482 | P16482 | CN16482 | Faricimab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
[113] Schedule 5, omit entries for Adefovir
[114] Schedule 5, entry for Azacitidine
substitute:
Azacitidine | GRP-20703 | Powder for injection 100 mg | Injection | Azacitidine Accord
Azacitidine Dr.Reddy's
AZACITIDINE EUGIA
Azacitidine Juno
Azacitidine MSN
Azacitidine Sandoz
Azacitidine SXP
Azacitidine-Teva |
[115] Schedule 5, entries for Bosentan
substitute:
Bosentan | GRP-21629 | Tablet 125 mg (as monohydrate) | Oral | Bosentan APO
BOSENTAN DR.REDDY'S
Bosentan GH
Bosentan Mylan
Bosentan RBX
Bosentan Viatris |
Bosentan | GRP-21635 | Tablet 62.5 mg (as monohydrate) | Oral | Bosentan APO
BOSENTAN DR.REDDY'S
Bosentan Mylan
Bosentan RBX |
[116] Schedule 5, entry for Capecitabine
omit from the column headed “Brand”: Capecitabine Alphapharm
[117] Schedule 5, entry for Ezetimibe in the form Tablet 10 mg [GRP-29270]
insert in the column headed “Brand” after entry for the Brand “APO-Ezetimibe”: ARX-Ezetimibe
[118] Schedule 5, after entry for Famciclovir [GRP-19913]
insert:
Faricimab | GRP-29679 | Solution for intravitreal injection 21 mg in 0.175 mL (120 mg per mL) pre-filled syringe | Injection | Vabysmo |
Faricimab | GRP-29679 | Solution for intravitreal injection 28.8 mg in 0.24 mL (120 mg per mL) | Injection | Vabysmo |
[119] Schedule 5, omit entries for Follitropin beta
[120] Schedule 5, entry for Ganirelix
insert in the column headed “Brand” after entry for the Brand “ARX Ganirelix”: Ganirelix Lupin
[121] Schedule 5, entries for Lercanidipine
substitute:
Lercanidipine | GRP-19829 | Tablet containing lercanidipine hydrochloride 20 mg | Oral | ARX-LERCANIDIPINE
Lercan
LERCANIDIPINE-WGR
Zanidip
Zircol 20 |
Lercanidipine | GRP-19911 | Tablet containing lercanidipine hydrochloride 10 mg | Oral | ARX-LERCANIDIPINE
Lercan
Lercanidipine APOTEX
LERCANIDIPINE-WGR
Zanidip
Zircol 10 |
[122] Schedule 5, entry for Levodopa with carbidopa [GRP-19870]
insert in the column headed “Brand” after entry for the Brand “Kinson”: ORIDOPA 100/25
[123] Schedule 5, entries for Methylprednisolone
omit:
Methylprednisolone | GRP-19893 | Powder for injection 1 g (as sodium succinate) | Injection | Methylpred
Solu-Medrol |
[124] Schedule 5, entries for Morphine
omit:
Morphine | GRP-28763 | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL | Oral | Ordine 5 |
Morphine | GRP-28763 | Oral solution containing morphine hydrochloride trihydrate 5 mg per mL, 1 mL (S19A) | Oral | RA-Morph (NZ) |
[125] Schedule 5, entries for Nebivolol in each of the forms: Tablet 5 mg (as hydrochloride); and Tablet 10 mg (as hydrochloride)
insert in the column headed “Brand” after entry for the Brand “APO-Nebivolol”: Nebaloc
[126] Schedule 5, entry for Paracetamol [GRP-20761]
insert in the column headed “Brand” after entry for the Brand “APOHEALTH Osteo Relief Paracetamol 665 mg”: Chemists' Own Osteo Relief Paracetamol
[127] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
omit from the column headed “Brand”: Indosyl Mono 4
[128] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
omit from the column headed “Brand”: Indosyl Mono 8
[129] Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit from the column headed “Brand”: Indosyl Mono 2
[130] Schedule 5, entry for Perindopril with indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg
omit from the column headed “Brand”: Indosyl Combi 4/1.25
[131] Schedule 5, omit entry for Polyethylene glycol 400 with propylene glycol
[132] Schedule 5, entries for Prazosin
substitute:
Prazosin | GRP-19831 | Tablet 2 mg (as hydrochloride) | Oral | APO-Prazosin
Minipress |
Prazosin | GRP-19871 | Tablet 5 mg (as hydrochloride) | Oral | APO-Prazosin
Minipress |
Prazosin | GRP-29678 | Capsule 1 mg (as hydrochloride) (S19A) | Oral | Prazosin Hydrochloride Capsules, USP 1 mg (Novitium Pharma, USA) |
Prazosin | GRP-29678 | Tablet 1 mg (as hydrochloride) | Oral | APO-Prazosin
Minipress |
[133] Schedule 5, entries for Rivaroxaban in each of the forms: Tablet 20 mg; Tablet 10 mg; and Tablet 15 mg
insert in the column headed “Brand” after entry for the Brand “Rivaroxaban-Teva”: RIVAXIB
[134] Schedule 5, omit entries for Tenecteplase
[135] Schedule 5, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg
insert in the column headed “Brand” after entry for the Brand “CIPLA TENOFOVIR + EMTRICITABINE 300/200”: TENOFOVIR/EMTRICITABINE 300/200 APX
[136] Schedule 5, entry for Tranexamic acid
insert in the column headed “Brand” after entry for the Brand “Tranexamic Acid Lupin”: Tranexamic Acid Waymade
