Commencement information
1. The whole of this instrument	1 June 2024	1 June 2024

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 [Brands: Adalicip; Humira; and Yuflyma; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12275 C12336

(b) insert in numerical order in the column headed “Circumstances”: C15249 C15309 C15319

(d) insert in numerical order in the column headed “Purposes”: P15249 P15309 P15319

[2] Schedule 1, Part 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Brands: Amgevita; Hadlima; Hyrimoz; and Idacio; Maximum Quantity: 6; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12275 C12336

(b) insert in numerical order in the column headed “Circumstances”: C15249 C15309 C15319

(d) insert in numerical order in the column headed “Purposes”: P15249 P15309 P15319

[3] Schedule 1, Part 1, entry for Adalimumab in each of the forms: Injection 80 mg in 0.8 mL pre-filled pen; and Injection 80 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 3; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C12275 C12278

(b) insert in numerical order in the column headed “Circumstances”: C15249 C15309 C15319

(d) insert in numerical order in the column headed “Purposes”: P15249 P15309 P15319

[4] Schedule 1, Part 1, entry for Alogliptin in the form Tablet 6.25 mg (as benzoate) [Maximum Quantity: 28; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4349 substitute: C15261

(b) omit from the column headed “Purposes”: P4349 substitute: P15261

[5] Schedule 1, Part 1, entry for Alogliptin in the form Tablet 6.25 mg (as benzoate) [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14862 substitute: C15287

(b) omit from the column headed “Purposes”: P14862 substitute: P15287

[6] Schedule 1, Part 1, entry for Alogliptin in the form Tablet 12.5 mg (as benzoate) [Maximum Quantity: 28; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4349 substitute: C15261

(b) omit from the column headed “Purposes”: P4349 substitute: P15261

[7] Schedule 1, Part 1, entry for Alogliptin in the form Tablet 12.5 mg (as benzoate) [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14862 substitute: C15287

(b) omit from the column headed “Purposes”: P14862 substitute: P15287

[8] Schedule 1, Part 1, entry for Alogliptin in the form Tablet 25 mg (as benzoate) [Maximum Quantity: 28; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4349 substitute: C15261

(b) omit from the column headed “Purposes”: P4349 substitute: P15261

[9] Schedule 1, Part 1, entry for Alogliptin in the form Tablet 25 mg (as benzoate) [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14862 substitute: C15287

(b) omit from the column headed “Purposes”: P14862 substitute: P15287

[10] Schedule 1, Part 1, entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 1 g metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4423 C4427 substitute: C15276

(b) omit from the column headed “Purposes”: P4423 P4427 substitute: P15276

[11] Schedule 1, Part 1, entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 1 g metformin hydrochloride [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14876 substitute: C15288

(b) omit from the column headed “Purposes”: P14876 substitute: P15288

[12] Schedule 1, Part 1, entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 500 mg metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4423 C4427 substitute: C15276

(b) omit from the column headed “Purposes”: P4423 P4427 substitute: P15276

[13] Schedule 1, Part 1, entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 500 mg metformin hydrochloride [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14876 substitute: C15288

(b) omit from the column headed “Purposes”: P14876 substitute: P15288

[14] Schedule 1, Part 1, entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 850 mg metformin hydrochloride [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4423 C4427 substitute: C15276

(b) omit from the column headed “Purposes”: P4423 P4427 substitute: P15276

[15] Schedule 1, Part 1, entry for Alogliptin with metformin in the form Tablet containing 12.5 mg alogliptin (as benzoate) with 850 mg metformin hydrochloride [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14876 substitute: C15288

(b) omit from the column headed “Purposes”: P14876 substitute: P15288

[16] Schedule 1, Part 1, entry for Ambrisentan in the form Tablet 5 mg

omit:

Ambrisentan

Tablet 5 mg

Oral

Ambrisentan Mylan

See Note 3

D(100)

[17] Schedule 1, Part 1, entry for Anastrozole

omit:

Anastrozole

Tablet 1 mg

Oral

Arimidex

MP NP

C5464

P5464

Anastrozole

Tablet 1 mg

Oral

Arimidex

MP NP

C14943

P14943

[18] Schedule 1, Part 1, entry for Apremilast in each of the forms: Pack containing 4 tablets 10 mg, 4 tablets 20 mg and 19 tablets 30 mg; and Tablet 30 mg

omit from the column headed “Circumstances”: C14417 substitute: C15326

[19] Schedule 1, Part 1, entry for Azacitidine

substitute:

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine Accord

See Note 3

PB(100)

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine Dr.Reddy's

See Note 3

PB(100)

Azacitidine

Powder for injection 100 mg

Injection

AZACITIDINE EUGIA

See Note 3

PB(100)

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine Juno

See Note 3

PB(100)

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine MSN

See Note 3

PB(100)

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine Sandoz

See Note 3

PB(100)

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine-Teva

See Note 3

PB(100)

Azacitidine

Tablet 200 mg

Oral

Onureg

C14338

Azacitidine

Tablet 300 mg

Oral

Onureg

C14332 C14338

P14332 P14338

Azacitidine

Tablet 300 mg

Oral

Onureg

C14323

P14323

[20] Schedule 1, Part 1, entry for Benzathine benzylpenicillin

substitute:

Benzathine benzylpenicillin

Injection containing 1,200,000 units benzathine benzylpenicillin tetrahydrate in 2.3 mL single use pre-filled syringe

Injection

Bicillin L-A

PDP MP NP

Benzathine benzylpenicillin

Injection containing 600,000 units benzathine benzylpenicillin tetrahydrate in 1.17 mL single use pre-filled syringe

Injection

Bicillin L-A

PDP MP NP

Benzathine benzylpenicillin

Powder for injection 1,200,000 units with diluent 5 mL (S19A)

Injection

Benzylpenicillin Benzathine (Brancaster Pharma, UK)

PDP MP NP

Benzathine benzylpenicillin

Powder for injection 1,200,000 units with diluent 5 mL (S19A)

Injection

Extencilline Benzathine Benzylpenicillin (France)

PDP MP NP

[21] Schedule 1, Part 1, entry for Bisacodyl

omit:

Bisacodyl

Enemas 10 mg in 5 mL, 25

Rectal

Bisalax

MP NP

C5613 C5640 C5685 C5720 C5775 C5776 C5804

[22] Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 1 mg

omit:

Bortezomib

Powder for injection 1 mg

Injection

Velcade

C11099 C13745

See Note 3

D(100)

[23] Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3 mg

omit:

Bortezomib

Powder for injection 3 mg

Injection

Velcade

C11099 C13745

See Note 3

D(100)

[24] Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Bortezomib

Powder for injection 3.5 mg

Injection

BORTEZOMIB EUGIA

C11099 C13745

See Note 3

D(100)

(b) omit:

Bortezomib

Powder for injection 3.5 mg

Injection

Velcade

C11099 C13745

See Note 3

D(100)

[25] Schedule 1, Part 1, entry for Bosentan

substitute:

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Bosentan APO

See Note 3

D(100)

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

BOSENTAN DR.REDDY'S

See Note 3

D(100)

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Bosentan Mylan

See Note 3

D(100)

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

Bosentan RBX

See Note 3

D(100)

Bosentan

Tablet 62.5 mg (as monohydrate)

Oral

BOSLEER

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan APO

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan Cipla

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

BOSENTAN DR.REDDY'S

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan GH

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan Mylan

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

Bosentan RBX

See Note 3

D(100)

Bosentan

Tablet 125 mg (as monohydrate)

Oral

BOSLEER

See Note 3

D(100)

[26] Schedule 1, Part 1, entry for Budesonide with formoterol

substitute:

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 100/6

C10538

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 100 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 100/6

MP NP

C4380

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 60 doses

Inhalation by mouth

Bufomix Easyhaler 200/6

MP NP

C10464

P10464

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 60 doses

Inhalation by mouth

Bufomix Easyhaler 200/6

MP NP

C7970

P7970

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 60 doses

Inhalation by mouth

Bufomix Easyhaler 200/6

C10538

P10538

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

BiResp Spiromax

MP NP

C10464

P10464

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

BiResp Spiromax

MP NP

C7970

P7970

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

BiResp Spiromax

C10538

P10538

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

DuoResp Spiromax

MP NP

C10464

P10464

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

DuoResp Spiromax

MP NP

C7970

P7970

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

DuoResp Spiromax

C10538

P10538

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast TURBUHALER 200/6

MP NP

C10464

P10464

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast TURBUHALER 200/6

MP NP

C7970

P7970

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast TURBUHALER 200/6

C10538

P10538

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 200/6

MP NP

C10464

P10464

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 200/6

MP NP

C7970

P7970

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Turbuhaler 200/6

C10538

P10538

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

BiResp Spiromax

MP NP

C7979 C10121

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Bufomix Easyhaler 400/12

MP NP

C7979 C10121

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

MP NP

C7979 C10121

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

DuoResp Spiromax

MP NP

C7979 C10121

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Rilast TURBUHALER 400/12

MP NP

C7979 C10121

Budesonide with formoterol

Powder for oral inhalation in breath actuated device containing budesonide 400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses

Inhalation by mouth

Symbicort TURBUHALER 400/12

MP NP

C7979 C10121

Budesonide with formoterol

Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 50/3

MP NP

C4397

Budesonide with formoterol

Pressurised inhalation containing budesonide 50 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 50/3

C10538

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3

MP NP

C10482

P10482

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3

MP NP

C4397

P4397

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 100/3

C10538

P10538

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 100/3

MP NP

C10482

P10482

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 100/3

MP NP

C4397

P4397

Budesonide with formoterol

Pressurised inhalation containing budesonide 100 micrograms with formoterol fumarate dihydrate 3 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 100/3

C10538

P10538

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6

MP NP

C4404 C10121

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Rilast RAPIHALER 200/6

C10538

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 200/6

MP NP

C4404 C10121

Budesonide with formoterol

Pressurised inhalation containing budesonide 200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses

Inhalation by mouth

Symbicort Rapihaler 200/6

C10538

[27] Schedule 1, Part 1, entry for Cefepime in the form Powder for injection 1 g (as hydrochloride)

omit:

Cefepime

Powder for injection 1 g (as hydrochloride)

Injection

Omegapharm Pty Ltd

MP NP

C5842

[28] Schedule 1, Part 1, entry for Cefepime in the form Powder for injection 2 g (as hydrochloride)

omit:

Cefepime

Powder for injection 2 g (as hydrochloride)

Injection

Omegapharm Pty Ltd

MP NP

C5842

[29] Schedule 1, Part 1, entry for Ceftriaxone in the form Powder for injection 1 g (as sodium)

omit:

Ceftriaxone

Powder for injection 1 g (as sodium)

Injection

Ceftriaxone Alphapharm

MP NP

C5830 C5862 C5868

Ceftriaxone

Powder for injection 1 g (as sodium)

Injection

Ceftriaxone Alphapharm

MP NP

C5830 C5862 C5868

[30] Schedule 1, Part 1, entry for Dapagliflozin

substitute:

Dapagliflozin

Tablet 10 mg (as propanediol monohydrate)

Oral

Forxiga

MP NP

C13230 C14471 C15047 C15311

P13230 P14471 P15047 P15311

Dapagliflozin

Tablet 10 mg (as propanediol monohydrate)

Oral

Forxiga

MP NP

C15051 C15265

P15051 P15265

[31] Schedule 1, Part 1, entry for Dapagliflozin with metformin

substitute:

Dapagliflozin with metformin

Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

Xigduo XR 5/1000

MP NP

C15289

P15289

Dapagliflozin with metformin

Tablet (modified release) containing 5 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

Xigduo XR 5/1000

MP NP

C15267

P15267

112

Dapagliflozin with metformin

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

Xigduo XR 10/1000

MP NP

C15289

P15289

Dapagliflozin with metformin

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 1000 mg metformin hydrochloride

Oral

Xigduo XR 10/1000

MP NP

C15267

P15267

Dapagliflozin with metformin

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride

Oral

Xigduo XR 10/500

MP NP

C15289

P15289

Dapagliflozin with metformin

Tablet (modified release) containing 10 mg dapagliflozin (as propanediol monohydrate) with 500 mg metformin hydrochloride

Oral

Xigduo XR 10/500

MP NP

C15267

P15267

[32] Schedule 1, Part 1, entry for Deucravacitinib

omit from the column headed “Circumstances”: C14384 substitute: C15330

[33] Schedule 1, Part 1, entry for Dicloxacillin in the form Capsule 250 mg (as sodium)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Dicloxacillin

Capsule 250 mg (as sodium)

Oral

DICLOXACILLIN VIATRIS 250

PDP

C5268

Dicloxacillin

Capsule 250 mg (as sodium)

Oral

DICLOXACILLIN VIATRIS 250

MP NP MW

C5415

[34] Schedule 1, Part 1, entry for Dosulepin in the form Capsule containing dosulepin hydrochloride 25 mg

omit:

Dosulepin

Capsule containing dosulepin hydrochloride 25 mg

Oral

Dosulepin Mylan

MP NP

[35] Schedule 1, Part 1, entry for Dulaglutide

omit from the column headed “Circumstances”: C5469 C5478 C7645 substitute: C15263 C15301

[36] Schedule 1, Part 1, entry for Empagliflozin

substitute:

Empagliflozin

Tablet 10 mg

Oral

Jardiance

MP NP

C13230 C14471 C15047 C15311

P13230 P14471 P15047 P15311

Empagliflozin

Tablet 10 mg

Oral

Jardiance

MP NP

C15051 C15265

P15051 P15265

Empagliflozin

Tablet 25 mg

Oral

Jardiance

MP NP

C15311

P15311

Empagliflozin

Tablet 25 mg

Oral

Jardiance

MP NP

C15265

P15265

[37] Schedule 1, Part 1, entry for Empagliflozin with linagliptin

substitute:

Empagliflozin with linagliptin

Tablet containing 10 mg empagliflozin with 5 mg linagliptin

Oral

Glyxambi

MP NP

C15269

P15269

Empagliflozin with linagliptin

Tablet containing 10 mg empagliflozin with 5 mg linagliptin

Oral

Glyxambi

MP NP

C15270

P15270

Empagliflozin with linagliptin

Tablet containing 25 mg empagliflozin with 5 mg linagliptin

Oral

Glyxambi

MP NP

C15269

P15269

Empagliflozin with linagliptin

Tablet containing 25 mg empagliflozin with 5 mg linagliptin

Oral

Glyxambi

MP NP

C15270

P15270

[38] Schedule 1, Part 1, entry for Empagliflozin with metformin

substitute:

Empagliflozin with metformin

Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride

Oral

Jardiamet 5 mg/1000 mg

MP NP

C15289

P15289

Empagliflozin with metformin

Tablet containing 5 mg empagliflozin with 1 g metformin hydrochloride

Oral

Jardiamet 5 mg/1000 mg

MP NP

C15267

P15267

120

Empagliflozin with metformin

Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride

Oral

Jardiamet 5 mg/500 mg

MP NP

C15289

P15289

Empagliflozin with metformin

Tablet containing 5 mg empagliflozin with 500 mg metformin hydrochloride

Oral

Jardiamet 5 mg/500 mg

MP NP

C15267

P15267

120

Empagliflozin with metformin

Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride

Oral

Jardiamet 12.5 mg/1000 mg

MP NP

C15289

P15289

Empagliflozin with metformin

Tablet containing 12.5 mg empagliflozin with 1 g metformin hydrochloride

Oral

Jardiamet 12.5 mg/1000 mg

MP NP

C15267

P15267

120

Empagliflozin with metformin

Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride

Oral

Jardiamet 12.5 mg/500 mg

MP NP

C15289

P15289

Empagliflozin with metformin

Tablet containing 12.5 mg empagliflozin with 500 mg metformin hydrochloride

Oral

Jardiamet 12.5 mg/500 mg

MP NP

C15267

P15267

120

[39] Schedule 1, Part 1, entry for Enalapril in the form Tablet containing enalapril maleate 5 mg

omit:

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

Enalapril generichealth

MP NP

Enalapril

Tablet containing enalapril maleate 5 mg

Oral

Enalapril generichealth

MP NP

P14238

[40] Schedule 1, Part 1, entry for Enalapril in the form Tablet containing enalapril maleate 10 mg

omit:

Enalapril

Tablet containing enalapril maleate 10 mg

Oral

Enalapril generichealth

MP NP

Enalapril

Tablet containing enalapril maleate 10 mg

Oral

Enalapril generichealth

MP NP

P14238

[41] Schedule 1, Part 1, entry for Estradiol in the form Transdermal patches 585 micrograms, 8

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Estradiol

Transdermal patches 585 micrograms, 8

Transdermal

Estradiol Transdermal System (Sandoz, USA)

MP NP

[42] Schedule 1, Part 1, entry for Estradiol in the form Transdermal patches 1.17 mg, 8

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Estradiol

Transdermal patches 1.17 mg, 8

Transdermal

Estradiol Transdermal System (Sandoz, USA)

MP NP

[43] Schedule 1, Part 1, entry for Estradiol in the form Transdermal patches 1.56 mg, 8

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Estradiol

Transdermal patches 1.56 mg, 8

Transdermal

Estradiol Transdermal System (Sandoz, USA)

MP NP

[44] Schedule 1, Part 1, entry for Furosemide in the form Tablet 20 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Furosemide

Tablet 20 mg

Oral

UREMIDE 20

MP NP

100

Furosemide

Tablet 20 mg

Oral

UREMIDE 20

MP NP

100

Furosemide

Tablet 20 mg

Oral

UREMIDE 20

MP NP

P14238

200

Furosemide

Tablet 20 mg

Oral

UREMIDE 20

MP NP

P14238

200

100

[45] Schedule 1, Part 1, entry for Inclisiran in the form Injection 284 mg in 1.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 0]

(a) insert in numerical order in the column headed “Circumstances”: C15313 C15323

(b) insert in numerical order in the column headed “Purposes”: P15313 P15323

[46] Schedule 1, Part 1, entry for Inclisiran in the form Injection 284 mg in 1.5 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C15122 C15132 C15144 C15153 substitute: C15315 C15331

(b) omit from the column headed “Purposes”: P15122 P15132 P15144 P15153 substitute: P15315 P15331

[47] Schedule 1, Part 1, after entry for Ivabradine in the form Tablet 7.5 mg (as hydrochloride) [Brand: Coralan]

insert:

Ivacaftor

Sachet containing granules 25 mg

Oral

Kalydeco

See Note 3

D(100)

[48] Schedule 1, Part 1, omit entry for Ketoconazole

[49] Schedule 1, Part 1, entry for Lamivudine with zidovudine

omit:

Lamivudine with zidovudine

Tablet 150 mg-300 mg

Oral

Lamivudine 150 mg + Zidovudine 300 mg Alphapharm

MP NP

C4454 C4512

120

D(100)

[50] Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 4 mg (as mesilate) [Maximum Quantity: 60; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C14007

(b) omit from the column headed “Purposes”: P14007

[51] Schedule 1, Part 1, entry for Lenvatinib in the form Capsule 10 mg (as mesilate)

omit from the column headed “Circumstances”: C14007

[52] Schedule 1, Part 1, entry for Linagliptin

substitute:

Linagliptin

Tablet 5 mg

Oral

Trajenta

MP NP

C15261

P15261

Linagliptin

Tablet 5 mg

Oral

Trajenta

MP NP

C15287

P15287

[53] Schedule 1, Part 1, entry for Linagliptin with metformin

substitute:

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride

Oral

Trajentamet

MP NP

C15276

P15276

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 1000 mg metformin hydrochloride

Oral

Trajentamet

MP NP

C15288

P15288

120

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride

Oral

Trajentamet

MP NP

C15276

P15276

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 500 mg metformin hydrochloride

Oral

Trajentamet

MP NP

C15288

P15288

120

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride

Oral

Trajentamet

MP NP

C15276

P15276

Linagliptin with metformin

Tablet containing 2.5 mg linagliptin with 850 mg metformin hydrochloride

Oral

Trajentamet

MP NP

C15288

P15288

120

[54] Schedule 1, Part 1, after entry for Medroxyprogesterone in the form Injection containing medroxyprogesterone acetate 150 mg in 1 mL [Brand: Depo-Ralovera]

insert:

Medroxyprogesterone

Injection containing medroxyprogesterone acetate 150 mg in 1 mL pre-filled syringe

Injection

Depo-Provera

MP NP

[55] Schedule 1, Part 1, entry for Methotrexate in the form Tablet 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Methotrexate

Tablet 2.5 mg

Oral

ARX-Methotrexate

MP NP

[56] Schedule 1, Part 1, entry for Methotrexate in the form Tablet 10 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Methotrexate

Tablet 10 mg

Oral

ARX-Methotrexate

MP NP

Methotrexate

Tablet 10 mg

Oral

ARX-Methotrexate

MP NP

P5648

[57] Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg

omit:

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

Noumed Mycophenolate

150

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

Noumed Mycophenolate

P14238

300

[58] Schedule 1, Part 1, entry for Naltrexone

omit:

Naltrexone

Tablet containing naltrexone hydrochloride 50 mg

Oral

ARX-NALTREXONE

MP NP

C13967

[59] Schedule 1, Part 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride)

omit:

Nebivolol

Tablet 1.25 mg (as hydrochloride)

Oral

Nebivolol Viatris

MP NP

C5324

P5324

Nebivolol

Tablet 1.25 mg (as hydrochloride)

Oral

Nebivolol Viatris

MP NP

C14251

P14251

112

[60] Schedule 1, Part 1, entry for Nebivolol in the form Tablet 10 mg (as hydrochloride)

omit:

Nebivolol

Tablet 10 mg (as hydrochloride)

Oral

Nebivolol Viatris

MP NP

C5324

P5324

Nebivolol

Tablet 10 mg (as hydrochloride)

Oral

Nebivolol Viatris

MP NP

C14251

P14251

[61] Schedule 1, Part 1, entry for Nivolumab

substitute:

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C14830

P14830

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C14001

P14001

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C11985

P11985

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C11468 C13433

P11468 P13433

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C10119 C10120 C13900

P10119 P10120 P13900

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C9216 C9312 C13445 C14816

P9216 P9312 P13445 P14816

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C9252 C9298 C9299 C9321 C11477 C13839

P9252 P9298 P9299 P9321 P11477 P13839

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 40 mg in 4 mL

Injection

Opdivo

C14676

P14676

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C14830

P14830

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C14001

P14001

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C11985

P11985

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C11468 C13433

P11468 P13433

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C10119 C10120 C13900

P10119 P10120 P13900

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C9216 C9312 C13445 C14816

P9216 P9312 P13445 P14816

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C9252 C9298 C9299 C9321 C11477 C13839

P9252 P9298 P9299 P9321 P11477 P13839

See Note 3

D(100)

Nivolumab

Injection concentrate for I.V. infusion 100 mg in 10 mL

Injection

Opdivo

C14676

P14676

See Note 3

D(100)

[62] Schedule 1, Part 1, entry for Olanzapine in the form Tablet 10 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Olanzapine

Tablet 10 mg

Oral

APO-OLANZAPINE

MP NP

C5856 C5869

[63] Schedule 1, Part 1, entry for Onasemnogene abeparvovec

substitute:

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

Onasemnogene abeparvovec

Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

See Note 3

D(100)

[64] Schedule 1, Part 1, entry for Ondansetron

substitute:

Ondansetron

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

Oral

Zofran syrup 50 mL

MP NP

C5721

P5721

V5721

Ondansetron

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

Oral

Zofran syrup 50 mL

C5778

P5778

V5778

C(100)

Ondansetron

Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL

Oral

Zofran syrup 50 mL

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APX-Ondansetron

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APX-Ondansetron

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

APX-Ondansetron

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Mylan Tablets

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Mylan Tablets

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Mylan Tablets

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron SZ

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron SZ

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron SZ

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron-DRLA

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron-DRLA

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Ondansetron-DRLA

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Zofran

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Zofran

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Zofran

MP NP

C15193

P15193

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Zotren 4

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Zotren 4

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 4 mg (as hydrochloride dihydrate)

Oral

Zotren 4

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

APX-Ondansetron ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

APX-Ondansetron ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

APX-Ondansetron ODT

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron Mylan ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron Mylan ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron Mylan ODT

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron ODT-DRLA

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron ODT-DRLA

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron ODT-DRLA

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron ODT Lupin

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron SZ ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron SZ ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Ondansetron SZ ODT

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Zotren ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Zotren ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 4 mg

Oral

Zotren ODT

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APO-Ondansetron

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APX-Ondansetron

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APX-Ondansetron

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

APX-Ondansetron

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Mylan Tablets

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Mylan Tablets

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Mylan Tablets

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron SZ

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron SZ

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron SZ

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron Tablets Viatris

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron-DRLA

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron-DRLA

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Ondansetron-DRLA

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Zofran

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Zofran

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Zofran

MP NP

C15193

P15193

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Zotren 8

MP NP

C4118

P4118

V4118

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Zotren 8

C5778

P5778

V5778

C(100)

Ondansetron

Tablet 8 mg (as hydrochloride dihydrate)

Oral

Zotren 8

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

APX-Ondansetron ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

APX-Ondansetron ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

APX-Ondansetron ODT

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron Mylan ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron Mylan ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron Mylan ODT

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT Viatris

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT Viatris

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT Viatris

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT-DRLA

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT-DRLA

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT-DRLA

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron ODT Lupin

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron SZ ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron SZ ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Ondansetron SZ ODT

MP NP

C15193

P15193

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Zotren ODT

MP NP

C5618

P5618

V5618

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Zotren ODT

C5743

P5743

V5743

C(100)

Ondansetron

Tablet (orally disintegrating) 8 mg

Oral

Zotren ODT

MP NP

C15193

P15193

Ondansetron

Wafer 4 mg

Oral

Zofran Zydis

MP NP

C15193

Ondansetron

Wafer 8 mg

Oral

Zofran Zydis

MP NP

C15193

[65] Schedule 1, Part 1, entry for Osimertinib in the form Tablet 40 mg

omit from the column headed “Circumstances”: C11181 C11183 substitute: C15257 C15283 C15310

[66] Schedule 1, Part 1, entry for Osimertinib in the form Tablet 80 mg

omit from the column headed “Circumstances”: C11178 C11181 C11183 C11185 substitute: C15257 C15281 C15283 C15299 C15329

[67] Schedule 1, Part 1, entry for Ozanimod in the form Capsule 920 micrograms [Maximum Quantity: 28; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C13993

(b) omit from the column headed “Purposes”: P13993

[68] Schedule 1, Part 1, entry for Pembrolizumab

substitute:

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C14818

P14818

See Note 3

D(100)

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C13431 C13432

P13431 P13432

See Note 3

D(100)

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C10705 C14770 C14786

P10705 P14770 P14786

See Note 3

D(100)

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C14817

P14817

See Note 3

D(100)

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C10676 C10688 C10701 C13436 C13437

P10676 P10688 P10701 P13436 P13437

See Note 3

D(100)

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C13726 C13727 C13728 C13730 C13731 C13732 C13735 C13736 C13739 C13741 C13948 C13949 C14027 C14028 C14044 C14324 C14403 C14404 C14405

P13726 P13727 P13728 P13730 P13731 P13732 P13735 P13736 P13739 P13741 P13948 P13949 P14027 P14028 P14044 P14324 P14403 P14404 P14405

See Note 3

D(100)

Pembrolizumab

Solution concentrate for I.V. infusion 100 mg in 4 mL

Injection

Keytruda

C14727

P14727

See Note 3

D(100)

[69] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Perindopril

Tablet containing perindopril arginine 2.5 mg

Oral

Perindopril Arginine Sandoz

MP NP

Perindopril

Tablet containing perindopril arginine 2.5 mg

Oral

Perindopril Arginine Sandoz

MP NP

P14238

[70] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Perindopril

Tablet containing perindopril arginine 5 mg

Oral

Perindopril Arginine Sandoz

MP NP

Perindopril

Tablet containing perindopril arginine 5 mg

Oral

Perindopril Arginine Sandoz

MP NP

P14238

[71] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril arginine 10 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Perindopril

Tablet containing perindopril arginine 10 mg

Oral

Perindopril Arginine Sandoz

MP NP

Perindopril

Tablet containing perindopril arginine 10 mg

Oral

Perindopril Arginine Sandoz

MP NP

P14238

[72] Schedule 1, Part 1, entry for Pioglitazone

substitute:

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Acpio 15

MP NP

C15321

P15321

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Acpio 15

MP NP

C15290

P15290

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Actaze

MP NP

C15321

P15321

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Actaze

MP NP

C15290

P15290

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Actos

MP NP

C15321

P15321

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Actos

MP NP

C15290

P15290

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

MP NP

C15321

P15321

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

MP NP

C15290

P15290

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Vexazone

MP NP

C15321

P15321

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

Vexazone

MP NP

C15290

P15290

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Acpio 30

MP NP

C15321

P15321

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Acpio 30

MP NP

C15290

P15290

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actaze

MP NP

C15321

P15321

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actaze

MP NP

C15290

P15290

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actos

MP NP

C15321

P15321

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Actos

MP NP

C15290

P15290

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

MP NP

C15321

P15321

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

MP NP

C15290

P15290

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Vexazone

MP NP

C15321

P15321

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

Vexazone

MP NP

C15290

P15290

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Acpio 45

MP NP

C15321

P15321

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Acpio 45

MP NP

C15290

P15290

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Actaze

MP NP

C15321

P15321

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Actaze

MP NP

C15290

P15290

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Actos

MP NP

C15321

P15321

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Actos

MP NP

C15290

P15290

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

MP NP

C15321

P15321

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

MP NP

C15290

P15290

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Vexazone

MP NP

C15321

P15321

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

Vexazone

MP NP

C15290

P15290

[73] Schedule 1, Part 1, entry for Plerixafor

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Plerixafor

Injection 24 mg in 1.2 mL

Injection

PLERIXAFOR EUGIA

C4549 C9329

D(100)

[74] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 50 mg (as fumarate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Quetiapine

Tablet (modified release) 50 mg (as fumarate)

Oral

Quetiapine Sandoz XR

MP NP

C4246 C5611 C5639

[75] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 150 mg (as fumarate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Quetiapine

Tablet (modified release) 150 mg (as fumarate)

Oral

Quetiapine Sandoz XR

MP NP

C4246 C5611 C5639

[76] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 200 mg (as fumarate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Quetiapine

Tablet (modified release) 200 mg (as fumarate)

Oral

Quetiapine Sandoz XR

MP NP

C4246 C5611 C5639

[77] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 300 mg (as fumarate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Quetiapine

Tablet (modified release) 300 mg (as fumarate)

Oral

Quetiapine Sandoz XR

MP NP

C4246 C5611 C5639

[78] Schedule 1, Part 1, entry for Quetiapine in the form Tablet (modified release) 400 mg (as fumarate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Quetiapine

Tablet (modified release) 400 mg (as fumarate)

Oral

Quetiapine Sandoz XR

MP NP

C4246 C5611 C5639

[79] Schedule 1, Part 1, entry for Ramipril in the form Tablet 2.5 mg

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Ramipril

Tablet 2.5 mg

Oral

Ramipril Viatris

MP NP

Ramipril

Tablet 2.5 mg

Oral

Ramipril Viatris

MP NP

P14238

[80] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 5 mg (as calcium)

omit:

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

P14238

[81] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 10 mg (as calcium)

(a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

APO-ROSUVASTATIN

MP NP

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

APO-ROSUVASTATIN

MP NP

P14238

(b) omit:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

P14238

[82] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 20 mg (as calcium)

omit:

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

P14238

[83] Schedule 1, Part 1, entry for Rosuvastatin in the form Tablet 40 mg (as calcium)

omit:

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

Noumed Rosuvastatin

MP NP

P14238

[84] Schedule 1, Part 1, entry for Ruxolitinib

substitute:

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13907 C13911

P13907 P13911

C(100)

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13867 C13906

P13867 P13906

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13876 C13892

P13876 P13892

C(100)

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13127 C13173

P13127 P13173

112

Ruxolitinib

Tablet 5 mg

Oral

Jakavi

C13128 C13130

P13128 P13130

112

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

C13127 C13173

P13127 P13173

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

C13907 C13911

P13907 P13911

C(100)

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

C13128 C13130 C13867 C13906

P13128 P13130 P13867 P13906

Ruxolitinib

Tablet 10 mg

Oral

Jakavi

C13876 C13892

P13876 P13892

C(100)

Ruxolitinib

Tablet 15 mg

Oral

Jakavi

C13127 C13173

P13127 P13173

Ruxolitinib

Tablet 15 mg

Oral

Jakavi

C13128 C13130

P13128 P13130

Ruxolitinib

Tablet 20 mg

Oral

Jakavi

C13127 C13173

P13127 P13173

Ruxolitinib

Tablet 20 mg

Oral

Jakavi

C13128 C13130

P13128 P13130

[85] Schedule 1, Part 1, entry for Saxagliptin

substitute:

Saxagliptin

Tablet 2.5 mg (as hydrochloride)

Oral

Onglyza

MP NP

C15261

P15261

Saxagliptin

Tablet 2.5 mg (as hydrochloride)

Oral

Onglyza

MP NP

C15287

P15287

Saxagliptin

Tablet 5 mg (as hydrochloride)

Oral

Onglyza

MP NP

C15261

P15261

Saxagliptin

Tablet 5 mg (as hydrochloride)

Oral

Onglyza

MP NP

C15287

P15287

[86] Schedule 1, Part 1, entry for Saxagliptin with dapagliflozin

substitute:

Saxagliptin with dapagliflozin

Tablet containing saxagliptin 5 mg with dapaglifozin 10 mg

Oral

Qtern 5/10

C15269

P15269

Saxagliptin with dapagliflozin

Tablet containing saxagliptin 5 mg with dapaglifozin 10 mg

Oral

Qtern 5/10

MP NP

C15270

P15270

[87] Schedule 1, Part 1, entry for Saxagliptin with metformin

substitute:

Saxagliptin with metformin

Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

Kombiglyze XR 2.5/1000

MP NP

C15276

P15276

Saxagliptin with metformin

Tablet (modified release) containing 2.5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

Kombiglyze XR 2.5/1000

MP NP

C15288

P15288

112

Saxagliptin with metformin

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

Kombiglyze XR 5/1000

MP NP

C15276

P15276

Saxagliptin with metformin

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 1000 mg metformin hydrochloride

Oral

Kombiglyze XR 5/1000

MP NP

C15288

P15288

Saxagliptin with metformin

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride

Oral

Kombiglyze XR 5/500

MP NP

C15276

P15276

Saxagliptin with metformin

Tablet (modified release) containing 5 mg saxagliptin (as hydrochloride) with 500 mg metformin hydrochloride

Oral

Kombiglyze XR 5/500

MP NP

C15288

P15288

[88] Schedule 1, Part 1, entry for Secukinumab

substitute:

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C11390 C12392

P11390 P12392

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C9064 C9429

P9064 P9429

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C9063 C9105 C9431 C10431 C14692

P9063 P9105 P9431 P10431 P14692

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C8831 C9064

P8831 P9064

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C15279 C15295 C15316 C15328

P15279 P15295 P15316 P15328

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C6696 C8830 C8892 C9063 C9105 C15317 C15325

P6696 P8830 P8892 P9063 P9105 P15317 P15325

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C9069 C9078 C9155 C14655 C14662 C14670

P9069 P9078 P9155 P14655 P14662 P14670

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C15127 C15137 C15158

P15127 P15137 P15158

Secukinumab

Injection 150 mg in 1 mL pre-filled pen

Injection

Cosentyx

C9069 C9078 C9155 C11089 C11096 C11138 C11154 C14430 C14462 C15280 C15296 C15307

P9069 P9078 P9155 P11089 P11096 P11138 P11154 P14430 P14462 P15280 P15296 P15307

[89] Schedule 1, Part 1, entry for Semaglutide in each of the forms: Solution for injection 2 mg in 1.5 mL pre-filled pen; and Solution for injection 4 mg in 3 mL pre-filled pen

omit from the column headed “Circumstances”: C5469 C5478 C5500 substitute: C15263 C15301

[90] Schedule 1, Part 1, entry for Sitagliptin

substitute:

Sitagliptin

Tablet 25 mg

Oral

Januvia

MP NP

C15261

P15261

Sitagliptin

Tablet 25 mg

Oral

Januvia

MP NP

C15287

P15287

Sitagliptin

Tablet 25 mg

Oral

Sitagliptin Lupin

MP NP

C15261

P15261

Sitagliptin

Tablet 25 mg

Oral

Sitagliptin Lupin

MP NP

C15287

P15287

Sitagliptin

Tablet 25 mg

Oral

Sitagliptin Sandoz Pharma

MP NP

C15261

P15261

Sitagliptin

Tablet 25 mg

Oral

Sitagliptin Sandoz Pharma

MP NP

C15287

P15287

Sitagliptin

Tablet 25 mg

Oral

Sitagliptin SUN

MP NP

C15261

P15261

Sitagliptin

Tablet 25 mg

Oral

Sitagliptin SUN

MP NP

C15287

P15287

Sitagliptin

Tablet 25 mg

Oral

Sitaglo

MP NP

C15261

P15261

Sitagliptin

Tablet 25 mg

Oral

Sitaglo

MP NP

C15287

P15287

Sitagliptin

Tablet 25 mg

Oral

Xelevia

MP NP

C15261

P15261

Sitagliptin

Tablet 25 mg

Oral

Xelevia

MP NP

C15287

P15287

Sitagliptin

Tablet 50 mg

Oral

Januvia

MP NP

C15261

P15261

Sitagliptin

Tablet 50 mg

Oral

Januvia

MP NP

C15287

P15287

Sitagliptin

Tablet 50 mg

Oral

Sitagliptin Lupin

MP NP

C15261

P15261

Sitagliptin

Tablet 50 mg

Oral

Sitagliptin Lupin

MP NP

C15287

P15287

Sitagliptin

Tablet 50 mg

Oral

Sitagliptin Sandoz Pharma

MP NP

C15261

P15261

Sitagliptin

Tablet 50 mg

Oral

Sitagliptin Sandoz Pharma

MP NP

C15287

P15287

Sitagliptin

Tablet 50 mg

Oral

Sitagliptin SUN

MP NP

C15261

P15261

Sitagliptin

Tablet 50 mg

Oral

Sitagliptin SUN

MP NP

C15287

P15287

Sitagliptin

Tablet 50 mg

Oral

Sitaglo

MP NP

C15261

P15261

Sitagliptin

Tablet 50 mg

Oral

Sitaglo

MP NP

C15287

P15287

Sitagliptin

Tablet 50 mg

Oral

Xelevia

MP NP

C15261

P15261

Sitagliptin

Tablet 50 mg

Oral

Xelevia

MP NP

C15287

P15287

Sitagliptin

Tablet 100 mg

Oral

Januvia

MP NP

C15261

P15261

Sitagliptin

Tablet 100 mg

Oral

Januvia

MP NP

C15287

P15287

Sitagliptin

Tablet 100 mg

Oral

Sitagliptin Lupin

MP NP

C15261

P15261

Sitagliptin

Tablet 100 mg

Oral

Sitagliptin Lupin

MP NP

C15287

P15287

Sitagliptin

Tablet 100 mg

Oral

Sitagliptin Sandoz Pharma

MP NP

C15261

P15261

Sitagliptin

Tablet 100 mg

Oral

Sitagliptin Sandoz Pharma

MP NP

C15287

P15287

Sitagliptin

Tablet 100 mg

Oral

Sitagliptin SUN

MP NP

C15261

P15261

Sitagliptin

Tablet 100 mg

Oral

Sitagliptin SUN

MP NP

C15287

P15287

Sitagliptin

Tablet 100 mg

Oral

Sitaglo

MP NP

C15261

P15261

Sitagliptin

Tablet 100 mg

Oral

Sitaglo

MP NP

C15287

P15287

Sitagliptin

Tablet 100 mg

Oral

Xelevia

MP NP

C15261

P15261

Sitagliptin

Tablet 100 mg

Oral

Xelevia

MP NP

C15287

P15287

[91] Schedule 1, Part 1, entry for Sitagliptin with metformin

substitute:

Sitagliptin with metformin

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz XR

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet (modified release) containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz XR

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet XR

MP NP

C15288

P15288

Sitagliptin with metformin

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz XR

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet (modified release) containing 100 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz XR

MP NP

C15288

P15288

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Janumet

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

SITAGLIPTIN/METFORMIN 50/1000 SUN

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

SITAGLIPTIN/METFORMIN 50/1000 SUN

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Velmetia

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 1000 mg metformin hydrochloride

Oral

Velmetia

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Janumet

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Janumet

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

SITAGLIPTIN/METFORMIN 50/500 SUN

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

SITAGLIPTIN/METFORMIN 50/500 SUN

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Velmetia

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 500 mg metformin hydrochloride

Oral

Velmetia

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Janumet

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Janumet

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

SITAGLIPTIN/METFORMIN 50/850 SUN

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

SITAGLIPTIN/METFORMIN 50/850 SUN

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Sitagliptin/Metformin Sandoz

MP NP

C15288

P15288

112

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Velmetia

MP NP

C15276

P15276

Sitagliptin with metformin

Tablet containing 50 mg sitagliptin with 850 mg metformin hydrochloride

Oral

Velmetia

MP NP

C15288

P15288

112

[92] Schedule 1, Part 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate)

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Sumatriptan

Tablet 50 mg (as succinate)

Oral

IMIGRAN MIGRAINE

MP NP

C5259

[93] Schedule 1, Part 1, entry for Tafamidis

(a) omit from the column headed “Circumstances”: C15088

(b) insert in numerical order in the column headed “Circumstances”: C15303

[94] Schedule 1, Part 1, entry for Tenofovir with emtricitabine

substitute:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

CIPLA TENOFOVIR + EMTRICITABINE 300/200

MP NP

C11143

P11143

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

CIPLA TENOFOVIR + EMTRICITABINE 300/200

MP NP

C6985 C6986

P6985 P6986

C(100)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine 300/200 APOTEX

MP NP

C11143

P11143

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine 300/200 APOTEX

MP NP

C6985 C6986

P6985 P6986

C(100)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

TENOFOVIR/EMTRICITABINE 300/200 ARX

MP NP

C11143

P11143

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

TENOFOVIR/EMTRICITABINE 300/200 ARX

MP NP

C6985 C6986

P6985 P6986

C(100)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg

Oral

Tenofovir Disoproxil Emtricitabine Viatris 300/200

MP NP

C11143

P11143

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg

Oral

Tenofovir Disoproxil Emtricitabine Viatris 300/200

MP NP

C6985 C6986

P6985 P6986

C(100)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg

Oral

Tenofovir EMT GH

MP NP

C11143

P11143

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg

Oral

Tenofovir EMT GH

MP NP

C6985 C6986

P6985 P6986

C(100)

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine Sandoz 301/200

MP NP

C11143

P11143

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine Sandoz 301/200

MP NP

C6985 C6986

P6985 P6986

C(100)

[95] Schedule 1, Part 1, entry for Teriparatide in the form Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled cartridge [Maximum Quantity: 2; Number of Repeats: 5]

omit from the column headed “Number of Repeats”: 5 substitute: 2

[96] Schedule 1, Part 1, entry for Testosterone in the form I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Testosterone

I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL

Injection

Testosterone ADVZ 1000

C6324 C6910 C6919 C6933 C6934

[97] Schedule 1, Part 1, entry for Tobramycin in the form Solution for inhalation 300 mg in 5 mL [Brand: Tobramycin WKT]

omit from the column headed “Responsible Person” (all instances): LI substitute (all instances): JU

[98] Schedule 1, Part 1, entry for Upadacitinib in each of the forms: Tablet 15 mg; and Tablet 30 mg [Maximum Quantity: 28; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C13930

(b) omit from the column headed “Purposes”: P13930

[99] Schedule 1, Part 1, entry for Ustekinumab in the form Injection 90 mg in 1 mL single use pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]

(a) omit from the column headed “Circumstances”: C14009

(b) omit from the column headed “Purposes”: P14009

[100] Schedule 1, Part 1, entry for Valaciclovir

omit:

Valaciclovir

Tablet 500 mg (as hydrochloride)

Oral

NOUMED VALACICLOVIR

MP NP

C5940 C5961

[101] Schedule 1, Part 1, entry for Vildagliptin in the form Tablet 50 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6346 C6363 C6376 substitute: C15261

(b) omit from the column headed “Purposes”: P6346 P6363 P6376 substitute: P15261

[102] Schedule 1, Part 1, entry for Vildagliptin in the form Tablet 50 mg [Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14978 C14999 C15000 substitute: C15287

(b) omit from the column headed “Purposes”: P14978 P14999 P15000 substitute: P15287

[103] Schedule 1, Part 1, entry for Vildagliptin with metformin

substitute:

Vildagliptin with metformin

Tablet containing 50 mg vildagliptin with 1000 mg metformin hydrochloride

Oral

Galvumet 50/1000

MP NP

C15276

P15276

Vildagliptin with metformin

Tablet contaiing 50 mg vildagliptin with 1000 mg metformin hydrochloride

Oral

Galvumet 50/1000

MP NP

C15288

P15288

120

Vildagliptin with metformin

Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride

Oral

Galvumet 50/500

MP NP

C15276

P15276

Vildagliptin with metformin

Tablet containing 50 mg vildagliptin with 500 mg metformin hydrochloride

Oral

Galvumet 50/500

MP NP

C15288

P15288

120

Vildagliptin with metformin

Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride

Oral

Galvumet 50/850

MP NP

C15276

P15276

Vildagliptin with metformin

Tablet containing 50 mg vildagliptin with 850 mg metformin hydrochloride

Oral

Galvumet 50/850

MP NP

C15288

P15288

120

[104] Schedule 1, Part 1, entry for Vosoritide in each of the forms: Powder for injection 400 micrograms with diluent; Powder for injection 560 micrograms with diluent; and Powder for injection 1.2 mg with diluent

omit from the column headed “Circumstances”: C13929

[105] Schedule 1, Part 2

insert as first entry:

Bisacodyl

Enemas 10 mg in 5 mL, 25

Rectal

Bisalax

[106] Schedule 1, Part 2, omit entry for Insulin neutral with insulin isophane

[107] Schedule 1, Part 2, after entry for Hypromellose with dextran

insert:

Ketoconazole

Cream 20 mg per g, 30 g

Application

Nizoral 2% Cream

[108] Schedule 1, Part 2, omit entry for Macrogol 3350

[109] Schedule 1, Part 2, omit entry for Pancrelipase

[110] Schedule 1, Part 2, omit entry for Paraffin with retinol palmitate

[111] Schedule 1, Part 2, omit entry for Raltegravir

[112] Schedule 3

omit:

Luminarie Pty Ltd

18 601 868 375

[113] Schedule 3, after details relevant for Responsible Person code XY

insert:

EUGIA PHARMA (AUSTRALIA) PTY LTD

57 656 083 028

[114] Schedule 3, after details relevant for Responsible Person code YN

insert:

The Trustee for ORSPEC PHARMA UNIT TRUST

15 634 980 417

[115] Schedule 4, Part 1, omit entry for Circumstances Code “C4072”

[116] Schedule 4, Part 1, omit entry for Circumstances Code “C4274”

[117] Schedule 4, Part 1, omit entry for Circumstances Code “C4275”

[118] Schedule 4, Part 1, omit entry for Circumstances Code “C4349”

[119] Schedule 4, Part 1, omit entry for Circumstances Code “C4363”

[120] Schedule 4, Part 1, omit entry for Circumstances Code “C4364”

[121] Schedule 4, Part 1, omit entry for Circumstances Code “C4388”

[122] Schedule 4, Part 1, omit entry for Circumstances Code “C4423”

[123] Schedule 4, Part 1, omit entry for Circumstances Code “C4427”

[124] Schedule 4, Part 1, omit entry for Circumstances Code “C4991”

[125] Schedule 4, Part 1, omit entry for Circumstances Code “C5469”

[126] Schedule 4, Part 1, omit entry for Circumstances Code “C5478”

[127] Schedule 4, Part 1, omit entry for Circumstances Code “C5500”

[128] Schedule 4, Part 1, omit entry for Circumstances Code “C5629”

[129] Schedule 4, Part 1, omit entry for Circumstances Code “C5631”

[130] Schedule 4, Part 1, omit entry for Circumstances Code “C5657”

[131] Schedule 4, Part 1, omit entry for Circumstances Code “C5739”

[132] Schedule 4, Part 1, omit entry for Circumstances Code “C5779”

[133] Schedule 4, Part 1, omit entry for Circumstances Code “C5798”

[134] Schedule 4, Part 1, omit entry for Circumstances Code “C5953”

[135] Schedule 4, Part 1, omit entry for Circumstances Code “C5966”

[136] Schedule 4, Part 1, omit entry for Circumstances Code “C6333”

[137] Schedule 4, Part 1, omit entry for Circumstances Code “C6334”

[138] Schedule 4, Part 1, omit entry for Circumstances Code “C6335”

[139] Schedule 4, Part 1, omit entry for Circumstances Code “C6336”

[140] Schedule 4, Part 1, omit entry for Circumstances Code “C6344”

[141] Schedule 4, Part 1, omit entry for Circumstances Code “C6346”

[142] Schedule 4, Part 1, omit entry for Circumstances Code “C6357”

[143] Schedule 4, Part 1, omit entry for Circumstances Code “C6363”

[144] Schedule 4, Part 1, omit entry for Circumstances Code “C6376”

[145] Schedule 4, Part 1, entry for Circumstances Code “C6434”

omit from the column headed “Listed Drug”: Ketoconazole

[146] Schedule 4, Part 1, omit entry for Circumstances Code “C6443”

[147] Schedule 4, Part 1, omit entry for Circumstances Code “C6645”

[148] Schedule 4, Part 1, omit entry for Circumstances Code “C6664”

[149] Schedule 4, Part 1, omit entry for Circumstances Code “C7492”

[150] Schedule 4, Part 1, omit entry for Circumstances Code “C7495”

[151] Schedule 4, Part 1, omit entry for Circumstances Code “C7498”

[152] Schedule 4, Part 1, omit entry for Circumstances Code “C7505”

[153] Schedule 4, Part 1, omit entry for Circumstances Code “C7506”

[154] Schedule 4, Part 1, omit entry for Circumstances Code “C7507”

[155] Schedule 4, Part 1, omit entry for Circumstances Code “C7524”

[156] Schedule 4, Part 1, omit entry for Circumstances Code “C7528”

[157] Schedule 4, Part 1, omit entry for Circumstances Code “C7530”

[158] Schedule 4, Part 1, omit entry for Circumstances Code “C7541”

[159] Schedule 4, Part 1, omit entry for Circumstances Code “C7556”

[160] Schedule 4, Part 1, omit entry for Circumstances Code “C7598”

[161] Schedule 4, Part 1, omit entry for Circumstances Code “C7629”

[162] Schedule 4, Part 1, omit entry for Circumstances Code “C7645”

[163] Schedule 4, Part 1, entry for Circumstances Code “C10742”

omit entry for Circumstances Code “C10742” and substitute:

C10742

P10742

CN10742

Guselkumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 20 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

[164] Schedule 4, Part 1, entry for Circumstances Code “C11090”

omit entry for Circumstances Code “C11090” and substitute:

C11090

P11090

CN11090

Tildrakizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.

Compliance with Written Authority Required procedures

[165] Schedule 4, Part 1, entry for Circumstances Code “C11096”

omit entry for Circumstances Code “C11096” and substitute:

C11096

P11096

CN11096

Ixekizumab

Secukinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[166] Schedule 4, Part 1, entry for Circumstances Code “C11119”

omit entry for Circumstances Code “C11119” and substitute:

C11119

P11119

CN11119

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[167] Schedule 4, Part 1, entry for Circumstances Code “C11123”

omit entry for Circumstances Code “C11123” and substitute:

C11123

P11123

CN11123

Tildrakizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[168] Schedule 4, Part 1, entry for Circumstances Code “C11130”

omit entry for Circumstances Code “C11130” and substitute:

C11130

P11130

CN11130

Guselkumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 20 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[169] Schedule 4, Part 1, entry for Circumstances Code “C11138”

omit entry for Circumstances Code “C11138” and substitute:

C11138

P11138

CN11138

Ixekizumab

Secukinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence 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.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[170] Schedule 4, Part 1, entry for Circumstances Code “C11153”

omit entry for Circumstances Code “C11153” and substitute:

C11153

P11153

CN11153

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[171] Schedule 4, Part 1, omit entry for Circumstances Code “C11178”

[172] Schedule 4, Part 1, omit entry for Circumstances Code “C11181”

[173] Schedule 4, Part 1, omit entry for Circumstances Code “C11183”

[174] Schedule 4, Part 1, omit entry for Circumstances Code “C11185”

[175] Schedule 4, Part 1, omit entry for Circumstances Code “C11229”

[176] Schedule 4, Part 1, entry for Circumstances Code “C11704”

omit from the column headed “Authority Requirements (part of Circumstances; or Conditions)”: Compliance with Authority Required procedures substitute: Compliance with Written Authority Required procedures

[177] Schedule 4, Part 1, entry for Circumstances Code “C11711”

[178] Schedule 4, Part 1, entry for Circumstances Code “C11715”

[179] Schedule 4, Part 1, entry for Circumstances Code “C11716”

[180] Schedule 4, Part 1, entry for Circumstances Code “C11717”

[181] Schedule 4, Part 1, entry for Circumstances Code “C11761”

[182] Schedule 4, Part 1, entry for Circumstances Code “C11762”

[183] Schedule 4, Part 1, entry for Circumstances Code “C11763”

[184] Schedule 4, Part 1, entry for Circumstances Code “C11767”

[185] Schedule 4, Part 1, omit entry for Circumstances Code “C11841”

[186] Schedule 4, Part 1, omit entry for Circumstances Code “C11842”

[187] Schedule 4, Part 1, entry for Circumstances Code “C11844”

[188] Schedule 4, Part 1, entry for Circumstances Code “C11846”

[189] Schedule 4, Part 1, omit entry for Circumstances Code “C11848”

[190] Schedule 4, Part 1, entry for Circumstances Code “C11861”

omit entry for Circumstances Code “C11861” and substitute:

C11861

P11861

CN11861

Adalimumab

Severe psoriatic arthritis

Initial treatment - Initial 2 (change or recommencement of treatment after a break in 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; AND

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).

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[191] Schedule 4, Part 1, entry for Circumstances Code “C11892”

[192] Schedule 4, Part 1, entry for Circumstances Code “C11893”

[193] Schedule 4, Part 1, entry for Circumstances Code “C11897”

[194] Schedule 4, Part 1, entry for Circumstances Code “C11902”

[195] Schedule 4, Part 1, entry for Circumstances Code “C11924”

[196] Schedule 4, Part 1, entry for Circumstances Code “C11926”

[197] Schedule 4, Part 1, entry for Circumstances Code “C11945”

omit entry for Circumstances Code “C11945” and substitute:

C11945

P11945

CN11945

Tofacitinib

Upadacitinib

Severe psoriatic arthritis

Initial treatment - Initial 2 (change or recommencement of treatment after a break in 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; AND

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 already 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

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Compliance with Written Authority Required procedures

[198] Schedule 4, Part 1, omit entry for Circumstances Code “C11950”

[199] Schedule 4, Part 1, entry for Circumstances Code “C11958”

omit entry for Circumstances Code “C11958” and substitute:

C11958

P11958

CN11958

Ixekizumab

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; AND

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 already 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 20 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

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

[200] Schedule 4, Part 1, entry for Circumstances Code “C11964”

[201] Schedule 4, Part 1, entry for Circumstances Code “C12155”

omit entry for Circumstances Code “C12155” and substitute:

C12155

P12155

CN12155

Adalimumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include

(1) a completed authority prescription form(s); and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[202] Schedule 4, Part 1, entry for Circumstances Code “C12212”

omit entry for Circumstances Code “C12212” and substitute:

C12212

P12212

CN12212

Adalimumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(1) a completed authority prescription form(s); and

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[203] Schedule 4, Part 1, entry for Circumstances Code “C12272”

[204] Schedule 4, Part 1, omit entry for Circumstances Code “C12275”

[205] Schedule 4, Part 1, omit entry for Circumstances Code “C12278”

[206] Schedule 4, Part 1, entry for Circumstances Code “C12306”

[207] Schedule 4, Part 1, entry for Circumstances Code “C12315”

[208] Schedule 4, Part 1, entry for Circumstances Code “C12399”

[209] Schedule 4, Part 1, entry for Circumstances Code “C12404”

[210] Schedule 4, Part 1, entry for Circumstances Code “C12405”

[211] Schedule 4, Part 1, entry for Circumstances Code “C12436”

[212] Schedule 4, Part 1, omit entry for Circumstances Code “C12439”

[213] Schedule 4, Part 1, entry for Circumstances Code “C12450”

[214] Schedule 4, Part 1, entry for Circumstances Code “C12451”

[215] Schedule 4, Part 1, entry for Circumstances Code “C12609”

[216] Schedule 4, Part 1, entry for Circumstances Code “C12614”

[217] Schedule 4, Part 1, omit entry for Circumstances Code “C12624”

[218] Schedule 4, Part 1, omit entry for Circumstances Code “C12625”

[219] Schedule 4, Part 1, entry for Circumstances Code “C12630”

[220] Schedule 4, Part 1, entry for Circumstances Code “C12635”

[221] Schedule 4, Part 1, entry for Circumstances Code “C12639”

[222] Schedule 4, Part 1, entry for Circumstances Code “C12672”

[223] Schedule 4, Part 1, entry for Circumstances Code “C12676”

[224] Schedule 4, Part 1, entry for Circumstances Code “C12703”

[225] Schedule 4, Part 1, entry for Circumstances Code “C12704”

[226] Schedule 4, Part 1, entry for Circumstances Code “C12705”

[227] Schedule 4, Part 1, entry for Circumstances Code “C12711”

[228] Schedule 4, Part 1, entry for Circumstances Code “C12712”

[229] Schedule 4, Part 1, entry for Circumstances Code “C12713”

[230] Schedule 4, Part 1, entry for Circumstances Code “C12721”

[231] Schedule 4, Part 1, entry for Circumstances Code “C12722”

[232] Schedule 4, Part 1, entry for Circumstances Code “C12723”

[233] Schedule 4, Part 1, entry for Circumstances Code “C12725”

[234] Schedule 4, Part 1, entry for Circumstances Code “C12726”

[235] Schedule 4, Part 1, entry for Circumstances Code “C12731”

[236] Schedule 4, Part 1, entry for Circumstances Code “C12738”

[237] Schedule 4, Part 1, entry for Circumstances Code “C12749”

[238] Schedule 4, Part 1, entry for Circumstances Code “C12752”

[239] Schedule 4, Part 1, entry for Circumstances Code “C12755”

[240] Schedule 4, Part 1, entry for Circumstances Code “C12758”

[241] Schedule 4, Part 1, entry for Circumstances Code “C12760”

[242] Schedule 4, Part 1, entry for Circumstances Code “C12765”

[243] Schedule 4, Part 1, entry for Circumstances Code “C12768”

[244] Schedule 4, Part 1, entry for Circumstances Code “C12769”

[245] Schedule 4, Part 1, entry for Circumstances Code “C12770”

[246] Schedule 4, Part 1, entry for Circumstances Code “C12771”

[247] Schedule 4, Part 1, entry for Circumstances Code “C12774”

[248] Schedule 4, Part 1, entry for Circumstances Code “C12775”

[249] Schedule 4, Part 1, entry for Circumstances Code “C12779”

[250] Schedule 4, Part 1, entry for Circumstances Code “C12780”

[251] Schedule 4, Part 1, entry for Circumstances Code “C12784”

[252] Schedule 4, Part 1, entry for Circumstances Code “C12785”

[253] Schedule 4, Part 1, entry for Circumstances Code “C12789”

[254] Schedule 4, Part 1, entry for Circumstances Code “C12790”

[255] Schedule 4, Part 1, entry for Circumstances Code “C12791”

[256] Schedule 4, Part 1, entry for Circumstances Code “C12793”

[257] Schedule 4, Part 1, entry for Circumstances Code “C12798”

[258] Schedule 4, Part 1, entry for Circumstances Code “C12803”

[259] Schedule 4, Part 1, entry for Circumstances Code “C12805”

[260] Schedule 4, Part 1, entry for Circumstances Code “C12806”

[261] Schedule 4, Part 1, entry for Circumstances Code “C12809”

[262] Schedule 4, Part 1, entry for Circumstances Code “C12810”

[263] Schedule 4, Part 1, entry for Circumstances Code “C12812”

[264] Schedule 4, Part 1, entry for Circumstances Code “C12817”

[265] Schedule 4, Part 1, entry for Circumstances Code “C12820”

[266] Schedule 4, Part 1, entry for Circumstances Code “C12824”

[267] Schedule 4, Part 1, entry for Circumstances Code “C12826”

[268] Schedule 4, Part 1, entry for Circumstances Code “C12829”

[269] Schedule 4, Part 1, entry for Circumstances Code “C12831”

[270] Schedule 4, Part 1, entry for Circumstances Code “C12832”

[271] Schedule 4, Part 1, entry for Circumstances Code “C12834”

[272] Schedule 4, Part 1, entry for Circumstances Code “C12855”

[273] Schedule 4, Part 1, entry for Circumstances Code “C12857”

[274] Schedule 4, Part 1, entry for Circumstances Code “C12858”

[275] Schedule 4, Part 1, entry for Circumstances Code “C12860”

[276] Schedule 4, Part 1, entry for Circumstances Code “C12861”

[277] Schedule 4, Part 1, entry for Circumstances Code “C12866”

[278] Schedule 4, Part 1, entry for Circumstances Code “C12867”

[279] Schedule 4, Part 1, entry for Circumstances Code “C12869”

[280] Schedule 4, Part 1, entry for Circumstances Code “C12671”

[281] Schedule 4, Part 1, entry for Circumstances Code “C12772”

[282] Schedule 4, Part 1, entry for Circumstances Code “C12876”

[283] Schedule 4, Part 1, entry for Circumstances Code “C12877”

[284] Schedule 4, Part 1, entry for Circumstances Code “C12880”

[285] Schedule 4, Part 1, entry for Circumstances Code “C12882”

[286] Schedule 4, Part 1, entry for Circumstances Code “C12884”

[287] Schedule 4, Part 1, entry for Circumstances Code “C12886”

[288] Schedule 4, Part 1, entry for Circumstances Code “C12887”

[289] Schedule 4, Part 1, entry for Circumstances Code “C12899”

[290] Schedule 4, Part 1, omit entry for Circumstances Code “C12983”

[291] Schedule 4, Part 1, omit entry for Circumstances Code “C12986”

[292] Schedule 4, Part 1, omit entry for Circumstances Code “C13010”

[293] Schedule 4, Part 1, omit entry for Circumstances Code “C13011”

[294] Schedule 4, Part 1, omit entry for Circumstances Code “C13012”

[295] Schedule 4, Part 1, omit entry for Circumstances Code “C13015”

[296] Schedule 4, Part 1, omit entry for Circumstances Code “C13029”

[297] Schedule 4, Part 1, entry for Circumstances Code “C13177”

[298] Schedule 4, Part 1, entry for Circumstances Code “C13184”

[299] Schedule 4, Part 1, entry for Circumstances Code “C13233”

[300] Schedule 4, Part 1, entry for Circumstances Code “C13250”

[301] Schedule 4, Part 1, omit entry for Circumstances Code “C13327”

[302] Schedule 4, Part 1, omit entry for Circumstances Code “C13377”

[303] Schedule 4, Part 1, omit entry for Circumstances Code “C13491”

[304] Schedule 4, Part 1, omit entry for Circumstances Code “C13496”

[305] Schedule 4, Part 1, omit entry for Circumstances Code “C13497”

[306] Schedule 4, Part 1, omit entry for Circumstances Code “C13499”

[307] Schedule 4, Part 1, omit entry for Circumstances Code “C13500”

[308] Schedule 4, Part 1, omit entry for Circumstances Code “C13502”

[309] Schedule 4, Part 1, omit entry for Circumstances Code “C13505”

[310] Schedule 4, Part 1, omit entry for Circumstances Code “C13506”

[311] Schedule 4, Part 1, omit entry for Circumstances Code “C13510”

[312] Schedule 4, Part 1, omit entry for Circumstances Code “C13512”

[313] Schedule 4, Part 1, omit entry for Circumstances Code “C13514”

[314] Schedule 4, Part 1, omit entry for Circumstances Code “C13515”

[315] Schedule 4, Part 1, omit entry for Circumstances Code “C13575”

[316] Schedule 4, Part 1, omit entry for Circumstances Code “C13576”

[317] Schedule 4, Part 1, omit entry for Circumstances Code “C13577”

[318] Schedule 4, Part 1, omit entry for Circumstances Code “C13582”

[319] Schedule 4, Part 1, entry for Circumstances Code “C13598”

omit entry for Circumstances Code “C13598” and substitute:

C13598

P13598

CN13598

Etanercept

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be at least 18 years of age;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.

To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe.

The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[320] Schedule 4, Part 1, entry for Circumstances Code “C13629”

[321] Schedule 4, Part 1, omit entry for Circumstances Code “C13631”

[322] Schedule 4, Part 1, omit entry for Circumstances Code “C13634”

[323] Schedule 4, Part 1, entry for Circumstances Code “C13646”

omit entry for Circumstances Code “C13646” and substitute:

C13646

P13646

CN13646

Etanercept

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be at least 18 years of age;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[324] Schedule 4, Part 1, entry for Circumstances Code “C13692”

omit entry for Circumstances Code “C13692” and substitute:

C13692

P13692

CN13692

Infliximab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 22 weeks of treatment under this restriction;

Patient must be at least 18 years of age;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[325] Schedule 4, Part 1, entry for Circumstances Code “C13719”

omit entry for Circumstances Code “C13719” and substitute:

C13719

P13719

CN13719

Infliximab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 22 weeks of treatment under this restriction;

Patient must be at least 18 years of age;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[326] Schedule 4, Part 1, omit entry for Circumstances Code “C13852”

[327] Schedule 4, Part 1, omit entry for Circumstances Code “C13863”

[328] Schedule 4, Part 1, omit entry for Circumstances Code “C13864”

[329] Schedule 4, Part 1, omit entry for Circumstances Code “C13865”

[330] Schedule 4, Part 1, omit entry for Circumstances Code “C13866”

[331] Schedule 4, Part 1, omit entry for Circumstances Code “C13877”

[332] Schedule 4, Part 1, omit entry for Circumstances Code “C13890”

[333] Schedule 4, Part 1, omit entry for Circumstances Code “C13891”

[334] Schedule 4, Part 1, omit entry for Circumstances Code “C13929”

[335] Schedule 4, Part 1, omit entry for Circumstances Code “C13930”

[336] Schedule 4, Part 1, omit entry for Circumstances Code “C13986”

[337] Schedule 4, Part 1, omit entry for Circumstances Code “C13993”

[338] Schedule 4, Part 1, omit entry for Circumstances Code “C14007”

[339] Schedule 4, Part 1, omit entry for Circumstances Code “C14009”

[340] Schedule 4, Part 1, omit entry for Circumstances Code “C14054”

[341] Schedule 4, Part 1, omit entry for Circumstances Code “C14101”

[342] Schedule 4, Part 1, omit entry for Circumstances Code “C14126”

[343] Schedule 4, Part 1, omit entry for Circumstances Code “C14127”

[344] Schedule 4, Part 1, omit entry for Circumstances Code “C14129”

[345] Schedule 4, Part 1, omit entry for Circumstances Code “C14130”

[346] Schedule 4, Part 1, omit entry for Circumstances Code “C14131”

[347] Schedule 4, Part 1, omit entry for Circumstances Code “C14132”

[348] Schedule 4, Part 1, entry for Circumstances Code “C14370”

omit entry for Circumstances Code “C14370” and substitute:

C14370

P14370

CN14370

Nusinersen

Spinal muscular atrophy (SMA)

Changing the prescribed therapy

Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient's 19th birthday; AND

Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or

Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND

Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND

Patient must be untreated with gene therapy; AND

Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.

Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.

The prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy.

Compliance with Authority Required procedures

[349] Schedule 4, Part 1, omit entry for Circumstances Code “C14384”

[350] Schedule 4, Part 1, entry for Circumstances Code “C14396”

omit entry for Circumstances Code “C14396” and substitute:

C14396

P14396

CN14396

Bimekizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 24 weeks of treatment under this restriction;

Patient must be at least 18 years of age;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include

(1) a completed authority prescription form(s); and

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[351] Schedule 4, Part 1, omit entry for Circumstances Code “C14417”

[352] Schedule 4, Part 1, entry for Circumstances Code “C14421”

omit entry for Circumstances Code “C14421” and substitute:

C14421

P14421

CN14421

Nusinersen

Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)

Changing the prescribed therapy

Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19th birthday for SMA type IIIB/IIIC; AND

Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or

Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND

Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment; AND

Patient must be untreated with gene therapy; AND

Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.

Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.

The prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy.

Compliance with Authority Required procedures

[353] Schedule 4, Part 1, entry for Circumstances Code “C14437”

omit entry for Circumstances Code “C14437” and substitute:

C14437

P14437

CN14437

Bimekizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; 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 already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 24 weeks of treatment under this restriction;

Patient must be at least 18 years of age;

Must be treated by a dermatologist.

An adequate response to treatment is defined as

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include

(1) a completed authority prescription form(s); and

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

Compliance with Written Authority Required procedures

[354] Schedule 4, Part 1, omit entry for Circumstances Code “C14523”

[355] Schedule 4, Part 1, omit entry for Circumstances Code “C14524”

[356] Schedule 4, Part 1, omit entry for Circumstances Code “C14555”

[357] Schedule 4, Part 1, omit entry for Circumstances Code “C14617”

[358] Schedule 4, Part 1, omit entry for Circumstances Code “C14858”

[359] Schedule 4, Part 1, omit entry for Circumstances Code “C14859”

[360] Schedule 4, Part 1, omit entry for Circumstances Code “C14862”

[361] Schedule 4, Part 1, omit entry for Circumstances Code “C14876”

[362] Schedule 4, Part 1, omit entry for Circumstances Code “C14878”

[363] Schedule 4, Part 1, omit entry for Circumstances Code “C14881”

[364] Schedule 4, Part 1, omit entry for Circumstances Code “C14885”

[365] Schedule 4, Part 1, omit entry for Circumstances Code “C14887”

[366] Schedule 4, Part 1, omit entry for Circumstances Code “C14888”

[367] Schedule 4, Part 1, omit entry for Circumstances Code “C14891”

[368] Schedule 4, Part 1, omit entry for Circumstances Code “C14894”

[369] Schedule 4, Part 1, omit entry for Circumstances Code “C14905”

[370] Schedule 4, Part 1, omit entry for Circumstances Code “C14911”

[371] Schedule 4, Part 1, omit entry for Circumstances Code “C14924”

[372] Schedule 4, Part 1, omit entry for Circumstances Code “C14925”

[373] Schedule 4, Part 1, omit entry for Circumstances Code “C14933”

[374] Schedule 4, Part 1, omit entry for Circumstances Code “C14935”

[375] Schedule 4, Part 1, omit entry for Circumstances Code “C14937”

[376] Schedule 4, Part 1, omit entry for Circumstances Code “C14949”

[377] Schedule 4, Part 1, omit entry for Circumstances Code “C14950”

[378] Schedule 4, Part 1, omit entry for Circumstances Code “C14954”

[379] Schedule 4, Part 1, omit entry for Circumstances Code “C14974”

[380] Schedule 4, Part 1, omit entry for Circumstances Code “C14978”

[381] Schedule 4, Part 1, omit entry for Circumstances Code “C14987”

[382] Schedule 4, Part 1, omit entry for Circumstances Code “C14999”

[383] Schedule 4, Part 1, omit entry for Circumstances Code “C15000”

[384] Schedule 4, Part 1, omit entry for Circumstances Code “C15001”

[385] Schedule 4, Part 1, omit entry for Circumstances Code “C15002”

[386] Schedule 4, Part 1, omit entry for Circumstances Code “C15014”

[387] Schedule 4, Part 1, entry for Circumstances Code “C15069”

omit entry for Circumstances Code “C15069” and substitute:

C15069

P15069

CN15069

Nusinersen

Spinal muscular atrophy (SMA)

Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) listing

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND

Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; or

Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND

The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND

The treatment must be given concomitantly with best supportive care for this condition; AND

The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug;

Patient must have been 18 years of age or younger at the time of initial treatment with this drug.

Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.

In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required.

Compliance with Authority Required procedures

[388] Schedule 4, Part 1, omit entry for Circumstances Code “C15088”

[389] Schedule 4, Part 1, entry for Circumstances Code “C15095”

omit entry for Circumstances Code “C15095” and substitute:

C15095

P15095

CN15095

Risdiplam

Spinal muscular atrophy (SMA)

Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene)

Patient must have previously received PBS-subsidised treatment with this drug for this condition; or

Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND

The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND

The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND

The treatment must be given concomitantly with best supportive care for this condition; AND

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND

Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy;

Patient must have been 18 years of age or younger at the time of initial treatment with this drug.

Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.

In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.

The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.

The approved Product Information recommended dosing is as follows

(i) 16 days to less than 2 months of age 0.15 mg/kg

(ii) 2 months to less than 2 years of age 0.20 mg/kg

(iii) 2 years of age and older weighing less than 20 kg 0.25 mg/kg

(iv) 2 years of age and older weighing 20 kg or more 5 mg

In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to

1 unit where (i) applies;

2 units where (ii) applies;

3 units where (iii) applies;

3 units where (iv) applies.

Compliance with Authority Required procedures

[390] Schedule 4, Part 1, entry for Circumstances Code “C15112”

omit entry for Circumstances Code “C15112” and substitute:

C15112

P15112

CN15112

Nusinersen

Spinal muscular atrophy (SMA)

Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listing