National Health (Listing of Pharmaceutical Benefits) Amendment

National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024)

[1] Schedule 1, Part 1, after entry for Abiraterone in the form Tablet containing abiraterone acetate 250 mg [Brand: Zytiga]

insert:

Abiraterone

Tablet containing abiraterone acetate 500 mg

Oral

Abiraterone Dr.Reddy's

C13945

[2] Schedule 1, Part 1, entry for Acetazolamide

insert in the column headed “Circumstances”: C16559

[3] Schedule 1, Part 1, entry for Aciclovir in the form Tablet 200 mg [Brand: ARX-Aciclovir]

substitute:

Aciclovir

Tablet 200 mg

Oral

ARX-ACICLOVIR

MP NP

C5936

P5936

Aciclovir

Tablet 200 mg

Oral

ARX-ACICLOVIR

MP MW NP

C5942

P5942

[4] Schedule 1, Part 1, entries for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen

omit:

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C11713 C15473

P11713 P15473

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C12120 C14061 C14063 C14064 C14107 C14136

See Note 3

C(100)

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C9064 C9386 C12174 C12194 C13599 C13650 C13681 C13694 C14483 C14486 C14488 C14496 C14498 C14568 C14590 C14655 C14662 C14670 C14672 C14673 C16414

P9064 P9386 P12174 P12194 P13599 P13650 P13681 P13694 P14483 P14486 P14488 P14496 P14498 P14568 P14590 P14655 P14662 P14670 P14672 P14673 P16414

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C11107 C12155 C12212 C13556 C13612 C14377 C14378

P11107 P12155 P12212 P13556 P13612 P14377 P14378

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C11523 C11524 C11579 C11604 C11606 C11631 C11635 C11704 C11711 C11717 C11718 C11767 C11853 C11865 C11867 C11903 C11906 C11966 C12122 C12123 C12148 C12156 C12157 C12158 C12189 C12190 C12214 C12228 C12240 C14493 C14499 C14507 C14567 C14656 C14683 C14701 C14713 C14730 C15445 C15446 C15450

P11523 P11524 P11579 P11604 P11606 P11631 P11635 P11704 P11711 P11717 P11718 P11767 P11853 P11865 P11867 P11903 P11906 P11966 P12122 P12123 P12148 P12156 P12157 P12158 P12189 P12190 P12214 P12228 P12240 P14493 P14499 P14507 P14567 P14656 P14683 P14701 P14713 P14730 P15445 P15446 P15450

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C15474 C15489

P15474 P15489

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C15788

P15788

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C11529 C15777 C15796

P11529 P15777 P15796

Adalimumab

Injection 40 mg in 0.4 mL pre-filled pen

Injection

Adalicip

C9715 C11709 C11715 C11716 C11759 C11761 C11852 C11854 C11855 C12098 C12101 C12147 C13602 C13609 C15764 C15765 C15795

P9715 P11709 P11715 P11716 P11759 P11761 P11852 P11854 P11855 P12098 P12101 P12147 P13602 P13609 P15764 P15765 P15795

[5] Schedule 1, Part 1, entry for Adapalene with benzoyl peroxide [Maximum Quantity: 1; Number of Repeats: 1]

omit from the column headed “Authorised Prescriber”: MP substitute: MP NP

[6] Schedule 1, Part 1, after entry for Allopurinol in the form Tablet 100 mg [Brand: NOUMED ALLOPURINOL; Maximum Quantity: 400; Number of Repeats: 2]

insert:

Allopurinol

Tablet 100 mg

Oral

Progout Viatris

MP NP

200

Allopurinol

Tablet 100 mg

Oral

Progout Viatris

MP NP

P14238

400

200

[7] Schedule 1, Part 1, entry for Amantadine in the form Capsule containing amantadine hydrochloride 100 mg [Brand: AMANTAMED; Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5132 substitute: C16670

(b) omit from the column headed “Purposes”: P5132 substitute: P16670

[8] Schedule 1, Part 1, entry for Amantadine in the form Capsule containing amantadine hydrochloride 100 mg [Brand: AMANTAMED; Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15711 substitute: C16621

(b) omit from the column headed “Purposes”: P15711 substitute: P16621

[9] Schedule 1, Part 1, entry for Amantadine in the form Capsule containing amantadine hydrochloride 100 mg [Brand: Symmetrel 100; Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5132 substitute: C16670

(b) omit from the column headed “Purposes”: P5132 substitute: P16670

[10] Schedule 1, Part 1, entry for Amantadine in the form Capsule containing amantadine hydrochloride 100 mg [Brand: Symmetrel 100; Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15711 substitute: C16621

(b) omit from the column headed “Purposes”: P15711 substitute: P16621

[11] Schedule 1, Part 1, entries for Azacitidine in the form Powder for injection 100 mg

omit:

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine-Teva

See Note 3

PB(100)

[12] Schedule 1, Part 1, entry for Balsalazide [Maximum Quantity: 280; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C7621 substitute: C16658

(b) omit from the column headed “Purposes”: P7621 substitute: P16658

[13] Schedule 1, Part 1, entry for Balsalazide [Maximum Quantity: 560; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14306 substitute: C16551

(b) omit from the column headed “Purposes”: P14306 substitute: P16551

[14] Schedule 1, Part 1, entry for Budesonide in the form Capsule (enteric) 3 mg

omit from the column headed “Circumstances”: C15772 substitute: C16695

[15] Schedule 1, Part 1, entry for Budesonide in the form Capsule (modified release) 3 mg

omit from the column headed “Circumstances”: C12607 substitute: C16674

[16] Schedule 1, Part 1, entry for Budesonide in the form Rectal foam 2 mg per application, 14 applications, aerosol 16.8 g, 2

insert in the column headed “Circumstances”: C16524

[17] Schedule 1, Part 1, entry for Cabergoline in the form Tablet 1 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5168 substitute: C16536

(b) omit from the column headed “Purposes”: P5168 substitute: P16536

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

(a) omit from the column headed “Circumstances”: C15636 substitute: C16540

(b) omit from the column headed “Purposes”: P15636 substitute: P16540

[19] Schedule 1, Part 1, entry for Cabergoline in the form Tablet 2 mg [Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5168 substitute: C16536

(b) omit from the column headed “Purposes”: P5168 substitute: P16536

[20] Schedule 1, Part 1, entry for Cabergoline in the form Tablet 2 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15636 substitute: C16540

(b) omit from the column headed “Purposes”: P15636 substitute: P16540

[21] Schedule 1, Part 1, entry for Calcitonin salmon

omit from the column headed “Circumstances”: C13886 C13913 substitute: C16575 C16678

[22] Schedule 1, Part 1, entries for Carbamazepine

substitute:

Carbamazepine

Oral suspension 100 mg per 5 mL, 300 mL

Oral

Tegretol Liquid

PDP

Carbamazepine

Oral suspension 100 mg per 5 mL, 300 mL

Oral

Tegretol Liquid

MP NP

P16524

Carbamazepine

Oral suspension 100 mg per 5 mL, 300 mL

Oral

Tegretol Liquid

MP NP

P16493

Carbamazepine

Tablet 100 mg

Oral

AVLOIRE

PDP

200

100

Carbamazepine

Tablet 100 mg

Oral

AVLOIRE

MP NP

P16524

200

100

Carbamazepine

Tablet 100 mg

Oral

AVLOIRE

MP NP

P16493

400

100

Carbamazepine

Tablet 100 mg

Oral

Tegretol 100

PDP

200

100

Carbamazepine

Tablet 100 mg

Oral

Tegretol 100

MP NP

P16524

200

100

Carbamazepine

Tablet 100 mg

Oral

Tegretol 100

MP NP

P16493

400

100

Carbamazepine

Tablet 200 mg

Oral

AVLOIRE

PDP

200

100

Carbamazepine

Tablet 200 mg

Oral

AVLOIRE

MP NP

P16524

200

100

Carbamazepine

Tablet 200 mg

Oral

AVLOIRE

MP NP

P16493

400

100

Carbamazepine

Tablet 200 mg

Oral

Tegretol 200

PDP

200

100

Carbamazepine

Tablet 200 mg

Oral

Tegretol 200

MP NP

P16524

200

100

Carbamazepine

Tablet 200 mg

Oral

Tegretol 200

MP NP

P16493

400

100

Carbamazepine

Tablet 200 mg (controlled release)

Oral

Tegretol CR 200

PDP

200

100

Carbamazepine

Tablet 200 mg (controlled release)

Oral

Tegretol CR 200

PDP

200

Carbamazepine

Tablet 200 mg (controlled release)

Oral

Tegretol CR 200

MP NP

P16524

200

100

Carbamazepine

Tablet 200 mg (controlled release)

Oral

Tegretol CR 200

MP NP

P16524

200

Carbamazepine

Tablet 200 mg (controlled release)

Oral

Tegretol CR 200

MP NP

P16493

400

100

Carbamazepine

Tablet 200 mg (controlled release)

Oral

Tegretol CR 200

MP NP

P16493

400

200

Carbamazepine

Tablet 400 mg (controlled release)

Oral

Tegretol CR 400

PDP

200

100

Carbamazepine

Tablet 400 mg (controlled release)

Oral

Tegretol CR 400

PDP

200

Carbamazepine

Tablet 400 mg (controlled release)

Oral

Tegretol CR 400

MP NP

P16524

200

100

Carbamazepine

Tablet 400 mg (controlled release)

Oral

Tegretol CR 400

MP NP

P16524

200

Carbamazepine

Tablet 400 mg (controlled release)

Oral

Tegretol CR 400

MP NP

P16493

400

100

Carbamazepine

Tablet 400 mg (controlled release)

Oral

Tegretol CR 400

MP NP

P16493

400

200

[23] Schedule 1, Part 1, entries for Carbimazole

substitute:

Carbimazole

Tablet 5 mg

Oral

Neo-Mercazole

MP NP

C16559

P16559

200

100

Carbimazole

Tablet 5 mg

Oral

Neo-Mercazole

MP NP

C16508

P16508

400

100

Carbimazole

Tablet 5 mg

Oral

THIRAZOL

MP NP

C16559

P16559

200

100

Carbimazole

Tablet 5 mg

Oral

THIRAZOL

MP NP

C16508

P16508

400

100

Carbimazole

Tablet 5 mg

Oral

WP Carbimazole

MP NP

C16559

P16559

200

100

Carbimazole

Tablet 5 mg

Oral

WP Carbimazole

MP NP

C16508

P16508

400

100

[24] Schedule 1, Part 1, entries for Ciclosporin in the form Capsule 25 mg

omit:

Ciclosporin

Capsule 25 mg

Oral

Cyclosporin Sandoz

Ciclosporin

Capsule 25 mg

Oral

Cyclosporin Sandoz

P14238

120

[25] Schedule 1, Part 1, entries for Ciclosporin in the form Capsule 50 mg

omit:

Ciclosporin

Capsule 50 mg

Oral

Cyclosporin Sandoz

Ciclosporin

Capsule 50 mg

Oral

Cyclosporin Sandoz

P14238

120

[26] Schedule 1, Part 1, entries for Ciclosporin in the form Capsule 100 mg

omit:

Ciclosporin

Capsule 100 mg

Oral

Cyclosporin Sandoz

Ciclosporin

Capsule 100 mg

Oral

Cyclosporin Sandoz

P14238

120

[27] Schedule 1, Part 1, entry for Clonazepam in the form Injection 1 mg in 2 mL (set containing solution 1 mg in 1 mL and 1 mL diluent) [Maximum Quantity: 5; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C6295 substitute: C16520

(b) omit from the column headed “Purposes”: P6295 substitute: P16520

[28] Schedule 1, Part 1, entry for Clonazepam in the form Oral liquid 2.5 mg per mL, 10 mL [Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C6296 substitute: C16517

(b) omit from the column headed “Purposes”: P6296 substitute: P16517

[29] Schedule 1, Part 1, entry for Clonazepam in the form Tablet 500 micrograms [Brand: Paxam 0.5; Maximum Quantity: 200; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6296 substitute: C16517

(b) omit from the column headed “Purposes”: P6296 substitute: P16517

[30] Schedule 1, Part 1, entry for Clonazepam in the form Tablet 500 micrograms [Brand: Rivotril; Maximum Quantity: 200; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6296 substitute: C16517

(b) omit from the column headed “Purposes”: P6296 substitute: P16517

[31] Schedule 1, Part 1, entry for Clonazepam in the form Tablet 2 mg [Maximum Quantity: 200; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6296 substitute: C16517

(b) omit from the column headed “Purposes”: P6296 substitute: P16517

[32] Schedule 1, Part 1, after entry for Codeine with paracetamol in the form Tablet containing codeine phosphate hemihydrate 30 mg with paracetamol 500 mg [Brand: Prodeine Forte; Authorised Prescriber: PDP; Maximum Quantity: 20; Number of Repeats: 0]

insert:

Colchicine

Tablet 500 micrograms

Oral

COLCHICINE-WGR

MP NP

[33] Schedule 1, Part 1, entry for Cortisone in the form Tablet containing cortisone acetate 5 mg [Maximum Quantity: 50; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[34] Schedule 1, Part 1, entry for Cortisone in the form Tablet containing cortisone acetate 5 mg [Maximum Quantity: 100; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[35] Schedule 1, Part 1, entry for Cortisone in the form Tablet containing cortisone acetate 25 mg [Maximum Quantity: 60; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[36] Schedule 1, Part 1, entry for Cortisone in the form Tablet containing cortisone acetate 25 mg [Maximum Quantity: 120; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[37] Schedule 1, Part 1, entry for Denosumab in the form Injection 120 mg in 1.7 mL

omit from the column headed “Circumstances”: C4150 C4158 C4504 substitute: C16512 C16514 C16608

[38] Schedule 1, Part 1, entry for Dexamfetamine

omit from the column headed “Circumstances”: C6226 C6227 substitute: C16596 C16629

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

omit:

Dicloxacillin

Capsule 250 mg (as sodium)

Oral

Dicloxacillin Mylan 250

PDP

C5268

Dicloxacillin

Capsule 250 mg (as sodium)

Oral

Dicloxacillin Mylan 250

MP NP MW

C5415

[40] Schedule 1, Part 1, after entry for Dicloxacillin in the form Capsule 500 mg (as sodium) [Brand: Distaph 500; Maximum Quantity: 48; Number of Repeats: 1]

insert:

Dienogest

Tablet 2 mg

Oral

Dinasane

MP NP

C16222

[41] Schedule 1, Part 1, entries for Donepezil

substitute:

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

APO-Donepezil

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

Arazil

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

Aricept

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

Aridon 5

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

Aridon APN 5

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

Donepezil GH

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

Donepezil Sandoz

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 5 mg

Oral

DONEPEZIL-WGR

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

APO-Donepezil

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

Arazil

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

Aricept

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

Aridon 10

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

Aridon APN 10

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

Donepezil GH

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

Donepezil Sandoz

MP NP

C13938 C13940 C13941

Donepezil

Tablet containing donepezil hydrochloride 10 mg

Oral

DONEPEZIL-WGR

MP NP

C13938 C13940 C13941

[42] Schedule 1, Part 1, entries for Drospirenone with ethinylestradiol in the form Pack containing 21 tablets 3 mg drospirenone with 30 micrograms ethinylestradiol and 7 inert tablets

omit from the column headed “Authorised Prescriber” (all instances): MP NP substitute (all instances): MP MW NP

[43] Schedule 1, Part 1, entries for Drospirenone with ethinylestradiol in the form Pack containing 24 tablets 3 mg drospirenone with 20 micrograms ethinylestradiol (as betadex clathrate) and 4 inert tablets

omit from the column headed “Authorised Prescriber” (all instances): MP NP substitute (all instances): MP MW NP

[44] Schedule 1, Part 1, entry for Entacapone [Maximum Quantity: 200; Number of Repeats: 4]

(a) omit from the column headed “Circumstances”: C5133 substitute: C16651

(b) omit from the column headed “Purposes”: P5133 substitute: P16651

[45] Schedule 1, Part 1, entry for Entacapone [Maximum Quantity: 400; Number of Repeats: 4]

(a) omit from the column headed “Circumstances”: C15602 substitute: C16690

(b) omit from the column headed “Purposes”: P15602 substitute: P16690

[46] Schedule 1, Part 1, entry for Esomeprazole in the form Capsule (enteric) 40 mg (as magnesium) [Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C8777 C8778 substitute: C16555 C16634

(b) omit from the column headed “Purposes”: P8777 P8778 substitute: P16555 P16634

[47] Schedule 1, Part 1, entry for Esomeprazole in the form Capsule (enteric) 40 mg (as magnesium) [Authorised Prescriber: MP NP; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15655 C15704 substitute: C16489 C16659

(b) omit from the column headed “Purposes”: P15655 P15704 substitute: P16489 P16659

[48] Schedule 1, Part 1, entries for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium)

substitute:

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

APO-Esomeprazole

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

APO-Esomeprazole

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

APO-Esomeprazole

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

APO-Esomeprazole

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

APO-Esomeprazole

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GH

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GH

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GH

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GH

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GH

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GxP

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GxP

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GxP

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GxP

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole GxP

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole RBX

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole RBX

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole RBX

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole RBX

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole RBX

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole Viatris

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole Viatris

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole Viatris

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole Viatris

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esomeprazole Viatris

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

ESOMEPRAZOLE-WGR

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

ESOMEPRAZOLE-WGR

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

ESOMEPRAZOLE-WGR

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

ESOMEPRAZOLE-WGR

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

ESOMEPRAZOLE-WGR

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esopreze

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esopreze

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esopreze

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esopreze

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Esopreze

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexazole

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexazole

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexazole

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexazole

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexazole

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexium

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexium

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexium

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexium

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexium

C15936

P15936

120

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexole

MP NP

C8902

P8902

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexole

MP NP

C16555 C16634

P16555 P16634

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexole

C11370

P11370

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexole

MP NP

C16489 C16659

P16489 P16659

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium)

Oral

Nexole

C15936

P15936

120

[49] Schedule 1, Part 1, entries for Ethosuximide in each of the forms: Capsule 250 mg; and Capsule 250 mg (s19A)

insert in the column headed “Circumstances”: C16524

[50] Schedule 1, Part 1, entry for Ethosuximide in the form Oral solution 250 mg per 5 mL, 200 mL [Maximum Quantity: 1; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[51] Schedule 1, Part 1, entry for Ethosuximide in the form Oral solution 250 mg per 5 mL, 200 mL [Maximum Quantity: 2; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[52] Schedule 1, Part 1, entries for Fludrocortisone

insert in the column headed “Circumstances” (all instances): C16559

[53] Schedule 1, Part 1, after entry for Fluoxetine in the form Capsule 20 mg (as hydrochloride) [Brand: Fluoxetine Sandoz; Maximum Quantity: 56; Number of Repeats: 2]

insert:

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

FLUOXETINE-WGR

MP NP

C4755 C6277

P4755 P6277

Fluoxetine

Capsule 20 mg (as hydrochloride)

Oral

FLUOXETINE-WGR

MP NP

C15582 C15666

P15582 P15666

[54] Schedule 1, Part 1, after entry for Fulvestrant [Brand: Fulvestrant Sandoz]

insert:

Fulvestrant

Injection 250 mg in 5 mL pre-filled syringe

Injection

Fulvestrant SXP

C11473

[55] Schedule 1, Part 1, entries for Furosemide in the form Tablet 40 mg

omit:

Furosemide

Tablet 40 mg

Oral

NOUMED FUROSEMIDE

MP NP

100

Furosemide

Tablet 40 mg

Oral

NOUMED FUROSEMIDE

MP NP

P14238

200

100

[56] Schedule 1, Part 1, entries for Gabapentin in the form Capsule 100 mg

omit from the column headed “Circumstances” (all instances): C4928 substitute (all instances): C16515

[57] Schedule 1, Part 1, entries for Gabapentin in the form Capsule 300 mg

omit from the column headed “Circumstances” (all instances): C4928 substitute (all instances): C16515

[58] Schedule 1, Part 1, entries for Gabapentin in the form Capsule 400 mg

omit from the column headed “Circumstances” (all instances): C4928 substitute (all instances): C16515

[59] Schedule 1, Part 1, entries for Gabapentin in the form Tablet 600 mg

omit from the column headed “Circumstances” (all instances): C4928 substitute (all instances): C16515

[60] Schedule 1, Part 1, entries for Gabapentin in the form Tablet 800 mg

omit from the column headed “Circumstances” (all instances): C4928 substitute (all instances): C16515

[61] Schedule 1, Part 1, entries for Galantamine

substitute:

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

APO-Galantamine MR

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Galantyl

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Gamine XR

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Reminyl

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 16 mg (as hydrobromide)

Oral

APO-Galantamine MR

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 16 mg (as hydrobromide)

Oral

Galantyl

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 16 mg (as hydrobromide)

Oral

Gamine XR

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 16 mg (as hydrobromide)

Oral

Reminyl

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 24 mg (as hydrobromide)

Oral

APO-Galantamine MR

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 24 mg (as hydrobromide)

Oral

Galantyl

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 24 mg (as hydrobromide)

Oral

Gamine XR

MP NP

C13938 C13940 C13941

Galantamine

Capsule (prolonged release) 24 mg (as hydrobromide)

Oral

Reminyl

MP NP

C13938 C13940 C13941

[62] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 4 mg [Brand: Hydrocortisone Viatris 4; Maximum Quantity: 50; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[63] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 4 mg [Brand: Hydrocortisone Viatris 4; Maximum Quantity: 100; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[64] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 4 mg [Brand: Hysone 4; Maximum Quantity: 50; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[65] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 4 mg [Brand: Hysone 4; Maximum Quantity: 100; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[66] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg [Brand: Hydrocortisone Viatris 20; Maximum Quantity: 60; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[67] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg [Brand: Hydrocortisone Viatris 20; Maximum Quantity: 120; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[68] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg [Brand: Hysone 20; Maximum Quantity: 60; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[69] Schedule 1, Part 1, entry for Hydrocortisone in the form Tablet 20 mg [Brand: Hysone 20; Maximum Quantity: 120; Number of Repeats: 4]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[70] Schedule 1, Part 1, entries for Hydromorphone

omit:

Hydromorphone

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A) (Pharmascience)

Oral

pms-HYDROmorphone

MP NP

C10764 C10770 C10777

P10764 P10770 P10777

500

V10764 V10770 V10777

500

Hydromorphone

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A) (Pharmascience)

Oral

pms-HYDROmorphone

PDP

C10859

P10859

500

Hydromorphone

Oral solution containing hydromorphone hydrochloride 1 mg per mL, 1 mL (S19A) (Pharmascience)

Oral

pms-HYDROmorphone

MP NP

C11697

P11697

500

V11697

500

[71] Schedule 1, Part 1, entry for Ibandronic acid

omit from the column headed “Circumstances”: C4922 substitute: C16679

[72] Schedule 1, Part 1, entry for Inclisiran [Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C16312

(b) omit from the column headed “Circumstances”: C16352

(d) omit from the column headed “Purposes”: P16352

[73] Schedule 1, Part 1, entries for Lacosamide

substitute:

Lacosamide

Oral solution 10 mg per mL, 200 mL

Oral

Vimpat

MP NP

C15070

P15070

Lacosamide

Oral solution 10 mg per mL, 200 mL

Oral

Vimpat

MP NP

C15089

P15089

Lacosamide

Oral solution 10 mg per mL, 200 mL

Oral

Vimpat

MP NP

C8770 C8815

P8770 P8815

Lacosamide

Oral solution 10 mg per mL, 200 mL

Oral

Vimpat

MP NP

C14857

P14857

Lacosamide

Tablet 50 mg

Oral

Lacosam

C8813

P8813

Lacosamide

Tablet 50 mg

Oral

Lacosam

MP NP

C8815 C15070

P8815 P15070

Lacosamide

Tablet 50 mg

Oral

Lacosam

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 50 mg

Oral

Lacosamide ARX

C8813

P8813

Lacosamide

Tablet 50 mg

Oral

Lacosamide ARX

MP NP

C8815 C15070

P8815 P15070

Lacosamide

Tablet 50 mg

Oral

Lacosamide ARX

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 50 mg

Oral

Lacosamide Lupin

C8813

P8813

Lacosamide

Tablet 50 mg

Oral

Lacosamide Lupin

MP NP

C8815 C15070

P8815 P15070

Lacosamide

Tablet 50 mg

Oral

Lacosamide Lupin

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 50 mg

Oral

Lacosamide Sandoz

C8813

P8813

Lacosamide

Tablet 50 mg

Oral

Lacosamide Sandoz

MP NP

C8815 C15070

P8815 P15070

Lacosamide

Tablet 50 mg

Oral

Lacosamide Sandoz

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 50 mg

Oral

Vimcosa

C8813

P8813

Lacosamide

Tablet 50 mg

Oral

Vimcosa

MP NP

C8815 C15070

P8815 P15070

Lacosamide

Tablet 50 mg

Oral

Vimcosa

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 50 mg

Oral

Vimpat

C8813

P8813

Lacosamide

Tablet 50 mg

Oral

Vimpat

MP NP

C8815 C15070

P8815 P15070

Lacosamide

Tablet 50 mg

Oral

Vimpat

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 100 mg

Oral

Lacosam

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 100 mg

Oral

Lacosam

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 100 mg

Oral

Lacosamide ARX

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 100 mg

Oral

Lacosamide ARX

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 100 mg

Oral

Lacosamide Lupin

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 100 mg

Oral

Lacosamide Lupin

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 100 mg

Oral

Lacosamide Sandoz

C8813 C12225

P8813 P12225

Lacosamide

Tablet 100 mg

Oral

Lacosamide Sandoz

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 100 mg

Oral

Lacosamide Sandoz

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 100 mg

Oral

Vimcosa

C8813 C12225

P8813 P12225

Lacosamide

Tablet 100 mg

Oral

Vimcosa

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 100 mg

Oral

Vimcosa

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 100 mg

Oral

Vimpat

C8813 C12225

P8813 P12225

Lacosamide

Tablet 100 mg

Oral

Vimpat

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 100 mg

Oral

Vimpat

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 150 mg

Oral

Lacosam

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 150 mg

Oral

Lacosam

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 150 mg

Oral

Lacosamide ARX

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 150 mg

Oral

Lacosamide ARX

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 150 mg

Oral

Lacosamide Lupin

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 150 mg

Oral

Lacosamide Lupin

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 150 mg

Oral

Lacosamide Sandoz

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 150 mg

Oral

Lacosamide Sandoz

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 150 mg

Oral

Vimcosa

C8813 C12225

P8813 P12225

Lacosamide

Tablet 150 mg

Oral

Vimcosa

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 150 mg

Oral

Vimcosa

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 150 mg

Oral

Vimpat

C8813 C12225

P8813 P12225

Lacosamide

Tablet 150 mg

Oral

Vimpat

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 150 mg

Oral

Vimpat

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 200 mg

Oral

Lacosam

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 200 mg

Oral

Lacosam

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 200 mg

Oral

Lacosamide ARX

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 200 mg

Oral

Lacosamide ARX

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 200 mg

Oral

Lacosamide Lupin

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 200 mg

Oral

Lacosamide Lupin

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 200 mg

Oral

Lacosamide Sandoz

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 200 mg

Oral

Lacosamide Sandoz

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 200 mg

Oral

Vimcosa

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 200 mg

Oral

Vimcosa

MP NP

C14857 C15089

P14857 P15089

112

Lacosamide

Tablet 200 mg

Oral

Vimpat

MP NP

C8770 C8815 C15070

P8770 P8815 P15070

Lacosamide

Tablet 200 mg

Oral

Vimpat

MP NP

C14857 C15089

P14857 P15089

112

[74] Schedule 1, Part 1, entries for Lamotrigine

substitute:

Lamotrigine

Tablet 5 mg

Oral

Lamictal

MP NP

C16580

P16580

Lamotrigine

Tablet 5 mg

Oral

Lamictal

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

APX-Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

APX-Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

Lamictal

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

Lamictal

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

LAMITAN

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

LAMITAN

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

Lamotrigine GH

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

Lamotrigine GH

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

Logem

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

Logem

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

Reedos 25

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

Reedos 25

MP NP

C16581

P16581

112

Lamotrigine

Tablet 25 mg

Oral

Sandoz Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 25 mg

Oral

Sandoz Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

APX-Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

APX-Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

Lamictal

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

Lamictal

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

LAMITAN

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

LAMITAN

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

Lamotrigine GH

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

Lamotrigine GH

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

Logem

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

Logem

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

Reedos 50

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

Reedos 50

MP NP

C16581

P16581

112

Lamotrigine

Tablet 50 mg

Oral

Sandoz Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 50 mg

Oral

Sandoz Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

APX-Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

APX-Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

Lamictal

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

Lamictal

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

LAMITAN

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

LAMITAN

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

Lamotrigine GH

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

Lamotrigine GH

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

Logem

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

Logem

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

Reedos 100

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

Reedos 100

MP NP

C16581

P16581

112

Lamotrigine

Tablet 100 mg

Oral

Sandoz Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 100 mg

Oral

Sandoz Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

APX-Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

APX-Lamotrigine

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

Lamictal

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

Lamictal

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

LAMITAN

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

LAMITAN

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

Lamotrigine GH

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

Lamotrigine GH

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

LAMOTRIGINE-WGR

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

Logem

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

Logem

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

Reedos 200

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

Reedos 200

MP NP

C16581

P16581

112

Lamotrigine

Tablet 200 mg

Oral

Sandoz Lamotrigine

MP NP

C16580

P16580

Lamotrigine

Tablet 200 mg

Oral

Sandoz Lamotrigine

MP NP

C16581

P16581

112

[75] Schedule 1, Part 1, entries for Levetiracetam

substitute:

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

APO-Levetiracetam

MP NP

C16646

P16646

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

APO-Levetiracetam

MP NP

C16519

P16519

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Keppra

MP NP

C16646

P16646

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Keppra

MP NP

C16519

P16519

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Kerron

MP NP

C16646

P16646

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Kerron

MP NP

C16519

P16519

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam GH

MP NP

C16646

P16646

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam GH

MP NP

C16519

P16519

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam-AFT

MP NP

C16646

P16646

Levetiracetam

Oral solution 100 mg per mL, 300 mL

Oral

Levetiracetam-AFT

MP NP

C16519

P16519

Levetiracetam

Tablet 250 mg

Oral

APO-Levetiracetam

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

APO-Levetiracetam

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Keppra

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Keppra

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Kevtam 250

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Kevtam 250

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Levactam

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Levactam

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam GH

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam GH

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam Mylan

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam Mylan

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam SZ

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam SZ

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam Viatris

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Levetiracetam Viatris

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

LEVETIRACETAM-WGR

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

LEVETIRACETAM-WGR

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

Levi 250

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

Levi 250

MP NP

C16615

P16615

120

Levetiracetam

Tablet 250 mg

Oral

NOUMED LEVETIRACETAM

MP NP

C16582

P16582

Levetiracetam

Tablet 250 mg

Oral

NOUMED LEVETIRACETAM

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

APO-Levetiracetam

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

APO-Levetiracetam

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Keppra

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Keppra

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Kevtam 500

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Kevtam 500

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Levactam

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Levactam

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Levetiracetam GH

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Levetiracetam GH

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Levetiracetam Mylan

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Levetiracetam Mylan

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Levetiracetam SZ

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Levetiracetam SZ

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

LEVETIRACETAM-WGR

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

LEVETIRACETAM-WGR

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

Levi 500

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

Levi 500

MP NP

C16615

P16615

120

Levetiracetam

Tablet 500 mg

Oral

NOUMED LEVETIRACETAM

MP NP

C16582

P16582

Levetiracetam

Tablet 500 mg

Oral

NOUMED LEVETIRACETAM

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

APO-Levetiracetam

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

APO-Levetiracetam

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Keppra

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Keppra

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Kevtam 1000

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Kevtam 1000

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Levactam

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Levactam

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Levetiracetam GH

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Levetiracetam GH

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Mylan

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Mylan

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Levetiracetam SZ

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Levetiracetam SZ

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Viatris

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Levetiracetam Viatris

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

LEVETIRACETAM-WGR

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

LEVETIRACETAM-WGR

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

Levi 1000

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

Levi 1000

MP NP

C16615

P16615

120

Levetiracetam

Tablet 1 g

Oral

NOUMED LEVETIRACETAM

MP NP

C16582

P16582

Levetiracetam

Tablet 1 g

Oral

NOUMED LEVETIRACETAM

MP NP

C16615

P16615

120

[76] Schedule 1, Part 1, entries for Levodopa with benserazide

substitute:

Levodopa with benserazide

Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar 62.5

MP NP

C16524

P16524

100

Levodopa with benserazide

Capsule containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar 62.5

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

MP NP

C16524

P16524

100

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release)

Oral

Madopar HBS

MP NP

C16524

P16524

100

Levodopa with benserazide

Capsule containing levodopa 100 mg with 25 mg benserazide (as hydrochloride) (sustained release)

Oral

Madopar HBS

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

MP NP

C16524

P16524

100

Levodopa with benserazide

Capsule containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 62.5

MP NP

C16524

P16524

100

Levodopa with benserazide

Dispersible tablet containing levodopa 50 mg with 12.5 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 62.5

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 125

MP NP

C16524

P16524

100

Levodopa with benserazide

Dispersible tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar Rapid 125

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

MP NP

C16524

P16524

100

Levodopa with benserazide

Tablet containing levodopa 100 mg with 25 mg benserazide (as hydrochloride)

Oral

Madopar 125

MP NP

C16493

P16493

200

100

Levodopa with benserazide

Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

MP NP

C16524

P16524

100

Levodopa with benserazide

Tablet containing levodopa 200 mg with 50 mg benserazide (as hydrochloride)

Oral

Madopar

MP NP

C16493

P16493

200

100

[77] Schedule 1, Part 1, entries for Levodopa with carbidopa

substitute:

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra-intestinal

Duodopa

MP NP

C10197

P10197

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra-intestinal

Duodopa

C10138 C10161

P10138 P10161

C(100)

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra-intestinal

Duodopa

MP NP

C10386

P10386

Levodopa with carbidopa

Intestinal gel containing levodopa 20 mg with carbidopa monohydrate 5 mg per mL, 100 mL

Intra-intestinal

Duodopa

C10363 C10375

P10363 P10375

C(100)

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Kinson

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Kinson

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

ORIDOPA 100/25

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

ORIDOPA 100/25

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

SINADOPA 100/25

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

SINADOPA 100/25

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Sinemet 100/25

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 100 mg-25 mg (as monohydrate)

Oral

Sinemet 100/25

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

APO-Levodopa/Carbidopa

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

SINADOPA 250/25

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

SINADOPA 250/25

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

Sinemet

MP NP

C16524

P16524

100

Levodopa with carbidopa

Tablet 250 mg-25 mg (as monohydrate)

Oral

Sinemet

MP NP

C16493

P16493

200

100

Levodopa with carbidopa

Tablet (modified release) 200 mg-50 mg (as monohydrate)

Oral

Sinemet CR

MP NP

C16688

P16688

100

Levodopa with carbidopa

Tablet (modified release) 200 mg-50 mg (as monohydrate)

Oral

Sinemet CR

MP NP

C16624

P16624

200

100

[78] Schedule 1, Part 1, entries for Levodopa with carbidopa and entacapone

substitute:

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Stalevo 50/12.5/200mg

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 50 mg-12.5 mg (as monohydrate)-200 mg

Oral

Stalevo 50/12.5/200mg

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Stalevo 75/18.75/200mg

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 75 mg-18.75 mg (as monohydrate)-200 mg

Oral

Stalevo 75/18.75/200mg

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Stalevo 100/25/200mg

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 100 mg-25 mg (as monohydrate)-200 mg

Oral

Stalevo 100/25/200mg

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Stalevo 125/31.25/200mg

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 125 mg-31.25 mg (as monohydrate)-200 mg

Oral

Stalevo 125/31.25/200mg

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Stalevo 150/37.5/200mg

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 150 mg-37.5 mg (as monohydrate)-200 mg

Oral

Stalevo 150/37.5/200mg

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Carlevent

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

L.C.E. Sandoz

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Lecteva

MP NP

C16533 C16534

P16533 P16534

400

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Stalevo 200/50/200mg

MP NP

C16591 C16592

P16591 P16592

200

100

Levodopa with carbidopa and entacapone

Tablet 200 mg-50 mg (as monohydrate)-200 mg

Oral

Stalevo 200/50/200mg

MP NP

C16533 C16534

P16533 P16534

400

100

[79] Schedule 1, Part 1, entries for Levonorgestrel with ethinylestradiol

omit from the column headed “Authorised Prescriber” (all instances): MP NP substitute (all instances): MP MW NP

[80] Schedule 1, Part 1, entries for Liothyronine

substitute:

Liothyronine

Tablet containing liothyronine sodium 20 micrograms

Oral

Tertroxin

MP NP

C16607 C16676

P16607 P16676

100

Liothyronine

Tablet containing liothyronine sodium 20 micrograms

Oral

Tertroxin

C6475

P6475

100

Liothyronine

Tablet containing liothyronine sodium 20 micrograms

Oral

Tertroxin

MP NP

C16510 C16698

P16510 P16698

200

100

[81] Schedule 1, Part 1, entries for Lisdexamfetamine

omit from the column headed “Circumstances” (all instances): C16154 substitute (all instances): C16597

[82] Schedule 1, Part 1, entries for Lithium in each of the forms: Tablet containing lithium carbonate 250 mg; and Tablet containing lithium carbonate 450 mg (slow release)

insert in the column headed “Circumstances”: C16559

[83] Schedule 1, Part 1, after entry for Macrogol 3350 in the form Sachets containing powder for oral solution 13.125 g with electrolytes, 30 [Brand: APOHEALTH Macrogol with Electrolytes; Maximum Quantity: 2; Number of Repeats: 5]

insert:

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Chemists’ Own Constipation Relief with electrolytes

MP NP

C4576 C4577 C4580 C4596 C4601

P4576 P4577 P4580 P4596 P4601

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Chemists’ Own Constipation Relief with electrolytes

MP NP

C6171

P6171

Macrogol 3350

Sachets containing powder for oral solution 13.125 g with electrolytes, 30

Oral

Chemists’ Own Constipation Relief with electrolytes

MP NP

C15688 C15730 C15745 C15746 C15747

P15688 P15730 P15745 P15746 P15747

[84] Schedule 1, Part 1, entries for Memantine

substitute:

Memantine

Tablet containing memantine hydrochloride 10 mg

Oral

APO-Memantine

MP NP

C13936 C13966 C14000

Memantine

Tablet containing memantine hydrochloride 10 mg

Oral

Ebixa

MP NP

C13936 C13966 C14000

Memantine

Tablet containing memantine hydrochloride 10 mg

Oral

Memantine generichealth

MP NP

C13936 C13966 C14000

Memantine

Tablet containing memantine hydrochloride 10 mg

Oral

Memanxa

MP NP

C13936 C13966 C14000

Memantine

Tablet containing memantine hydrochloride 20 mg

Oral

APO-Memantine

MP NP

C13936 C13966 C14000

Memantine

Tablet containing memantine hydrochloride 20 mg

Oral

Ebixa

MP NP

C13936 C13966 C14000

Memantine

Tablet containing memantine hydrochloride 20 mg

Oral

Memantine generichealth

MP NP

C13936 C13966 C14000

[85] Schedule 1, Part 1, entries for Mesalazine

substitute:

Mesalazine

Enemas 1 g in 100 mL, 7

Rectal

Pentasa

MP NP

C16632

P16632

Mesalazine

Enemas 1 g in 100 mL, 7

Rectal

Pentasa

MP NP

C16656

P16656

Mesalazine

Enemas 2 g in 60 mL, 7

Rectal

Salofalk

MP NP

C16632

P16632

Mesalazine

Enemas 2 g in 60 mL, 7

Rectal

Salofalk

MP NP

C16656

P16656

Mesalazine

Enemas 4 g in 60 mL, 7

Rectal

Salofalk

MP NP

C16632

P16632

Mesalazine

Enemas 4 g in 60 mL, 7

Rectal

Salofalk

MP NP

C16656

P16656

Mesalazine

Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g

Rectal

Salofalk

MP NP

C16632

P16632

Mesalazine

Rectal foam 1 g per applicatorful, 14 applications, aerosol 80 g

Rectal

Salofalk

MP NP

C16656

P16656

Mesalazine

Sachet containing granules, 500 mg per sachet

Oral

Salofalk

MP NP

C16552

P16552

200

100

Mesalazine

Sachet containing granules, 500 mg per sachet

Oral

Salofalk

MP NP

C16491

P16491

400

100

Mesalazine

Sachet containing granules, 1 g per sachet

Oral

Salofalk

MP NP

C16552

P16552

100

Mesalazine

Sachet containing granules, 1 g per sachet

Oral

Salofalk

MP NP

C16491

P16491

200

100

Mesalazine

Sachet containing granules, 1.5 g per sachet

Oral

Salofalk

MP NP

C16552

P16552

Mesalazine

Sachet containing granules, 1.5 g per sachet

Oral

Salofalk

MP NP

C16491

P16491

120

Mesalazine

Sachet containing granules, 3 g per sachet

Oral

Salofalk

MP NP

C16552

P16552

Mesalazine

Sachet containing granules, 3 g per sachet

Oral

Salofalk

MP NP

C16491

P16491

Mesalazine

Sachet containing prolonged release granules, 1 g per sachet

Oral

Pentasa

MP NP

C16490 C16552

P16490 P16552

100

Mesalazine

Sachet containing prolonged release granules, 1 g per sachet

Oral

Pentasa

MP NP

C16491 C16603

P16491 P16603

200

100

Mesalazine

Sachet containing prolonged release granules, 2 g per sachet

Oral

Pentasa

MP NP

C16490 C16552

P16490 P16552

Mesalazine

Sachet containing prolonged release granules, 2 g per sachet

Oral

Pentasa

MP NP

C16491 C16603

P16491 P16603

120

Mesalazine

Sachet containing prolonged release granules, 4 g per sachet

Oral

Pentasa

MP NP

C16552

P16552

Mesalazine

Sachet containing prolonged release granules, 4 g per sachet

Oral

Pentasa

MP NP

C16491

P16491

Mesalazine

Suppository 1 g

Rectal

Pentasa

MP NP

C16633

P16633

Mesalazine

Suppository 1 g

Rectal

Pentasa

MP NP

C16548

P16548

Mesalazine

Suppository (moulded) 1 g

Rectal

Salofalk

MP NP

C16633

P16633

Mesalazine

Suppository (moulded) 1 g

Rectal

Salofalk

MP NP

C16548

P16548

Mesalazine

Tablet 250 mg (enteric coated)

Oral

Mesasal

MP NP

C16490 C16552

P16490 P16552

100

Mesalazine

Tablet 250 mg (enteric coated)

Oral

Mesasal

MP NP

C16491 C16603

P16491 P16603

200

100

Mesalazine

Tablet 500 mg (enteric coated)

Oral

Salofalk

MP NP

C16490 C16552

P16490 P16552

200

100

Mesalazine

Tablet 500 mg (enteric coated)

Oral

Salofalk

MP NP

C16491 C16603

P16491 P16603

400

100

Mesalazine

Tablet 500 mg (prolonged release)

Oral

Pentasa

MP NP

C16490 C16552

P16490 P16552

200

100

Mesalazine

Tablet 500 mg (prolonged release)

Oral

Pentasa

MP NP

C16491 C16603

P16491 P16603

400

100

Mesalazine

Tablet 800 mg (enteric coated)

Oral

Asacol

MP NP

C16552

P16552

Mesalazine

Tablet 800 mg (enteric coated)

Oral

Asacol

MP NP

C16491

P16491

180

Mesalazine

Tablet 1 g (enteric coated)

Oral

Salofalk

MP NP

C16490 C16552

P16490 P16552

120

Mesalazine

Tablet 1 g (enteric coated)

Oral

Salofalk

MP NP

C16491 C16603

P16491 P16603

240

Mesalazine

Tablet 1 g (prolonged release)

Oral

Pentasa

MP NP

C16490 C16552

P16490 P16552

120

Mesalazine

Tablet 1 g (prolonged release)

Oral

Pentasa

MP NP

C16491 C16603

P16491 P16603

240

Mesalazine

Tablet 1.2 g (prolonged release)

Oral

Mesalazine 1.2 TAKEDA

MP NP

C16552

P16552

120

Mesalazine

Tablet 1.2 g (prolonged release)

Oral

Mesalazine 1.2 TAKEDA

MP NP

C16491

P16491

240

Mesalazine

Tablet 1.2 g (prolonged release)

Oral

MESALZ

MP NP

C16552

P16552

120

Mesalazine

Tablet 1.2 g (prolonged release)

Oral

MESALZ

MP NP

C16491

P16491

240

120

Mesalazine

Tablet 1.2 g (prolonged release)

Oral

Mezavant

MP NP

C16552

P16552

120

Mesalazine

Tablet 1.2 g (prolonged release)

Oral

Mezavant

MP NP

C16491

P16491

240

Mesalazine

Tablet 1.6 g (enteric coated)

Oral

Asacol

MP NP

C16552

P16552

120

Mesalazine

Tablet 1.6 g (enteric coated)

Oral

Asacol

MP NP

C16491

P16491

240

[86] Schedule 1, Part 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg [Brand: APO-Metformin XR 500; Maximum Quantity: 240; Number of Repeats: 5]

insert:

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Blooms Metformin XR

MP MW NP

C16261

P16261

120

Metformin

Tablet (extended release) containing metformin hydrochloride 500 mg

Oral

Blooms Metformin XR

MP NP

C14238

P14238

240

120

[87] Schedule 1, Part 1, after entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 1 g [Brand: APO-Metformin XR 1000; Maximum Quantity: 120; Number of Repeats: 5]

insert:

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

Blooms Metformin XR

MP MW NP

C16261

P16261

Metformin

Tablet (extended release) containing metformin hydrochloride 1 g

Oral

Blooms Metformin XR

MP NP

C14238

P14238

120

[88] Schedule 1, Part 1, entries for Methylphenidate

substitute:

Methylphenidate

Capsule containing methylphenidate hydrochloride 10 mg (modified release)

Oral

Ritalin LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 10 mg (modified release)

Oral

Rubifen LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 20 mg (modified release)

Oral

Ritalin LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 20 mg (modified release)

Oral

Rubifen LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 30 mg (modified release)

Oral

Ritalin LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 30 mg (modified release)

Oral

Rubifen LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 40 mg (modified release)

Oral

Ritalin LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 40 mg (modified release)

Oral

Rubifen LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 60 mg (modified release)

Oral

Ritalin LA

MP NP

C16545

Methylphenidate

Capsule containing methylphenidate hydrochloride 60 mg (modified release)

Oral

Rubifen LA

MP NP

C16545

Methylphenidate

Tablet containing methylphenidate hydrochloride 10 mg

Oral

Artige

MP NP

C16596

100

Methylphenidate

Tablet containing methylphenidate hydrochloride 10 mg

Oral

Ritalin 10

MP NP

C16596

100

Methylphenidate

Tablet containing methylphenidate hydrochloride 18 mg (extended release)

Oral

Concerta

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 18 mg (extended release)

Oral

Methylphenidate XR ARX

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 18 mg (extended release)

Oral

METHYLPHENIDATE-TEVA XR

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 27 mg (extended release)

Oral

Concerta

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 27 mg (extended release)

Oral

Methylphenidate XR ARX

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 27 mg (extended release)

Oral

METHYLPHENIDATE-TEVA XR

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 36 mg (extended release)

Oral

Concerta

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 36 mg (extended release)

Oral

Methylphenidate XR ARX

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 36 mg (extended release)

Oral

METHYLPHENIDATE-TEVA XR

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 54 mg (extended release)

Oral

Concerta

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 54 mg (extended release)

Oral

Methylphenidate XR ARX

MP NP

C16598

Methylphenidate

Tablet containing methylphenidate hydrochloride 54 mg (extended release)

Oral

METHYLPHENIDATE-TEVA XR

MP NP

C16598

[89] Schedule 1, Part 1, entry for Methylprednisolone

omit:

Methylprednisolone

Powder for injection 1 g (as sodium succinate)

Injection

Solu-Medrol

MP NP

[90] Schedule 1, Part 1, entry for Nitrazepam in the form Tablet 5 mg [Brand: Alodorm; Maximum Quantity: 50; Number of Repeats: 5]

(a) omit from the column headed “Purposes”: P5661 P5771

(b) insert in numerical order in the column headed “Purposes”: P16653 P16692

(d) insert in numerical order in the column headed “Maximum Quantity”: CN16653 CN16692

(e) omit from the column headed “Number of Repeats”: CN5661 CN5771

(f) insert in numerical order in the column headed “Number of Repeats”: CN16653 CN16692

[91] Schedule 1, Part 1, entry for Nitrazepam in the form Tablet 5 mg [Brand: Mogadon; Maximum Quantity: 50; Number of Repeats: 5]

(a) omit from the column headed “Purposes”: P5661 P5771

(b) insert in numerical order in the column headed “Purposes”: P16653 P16692

(d) insert in numerical order in the column headed “Maximum Quantity”: CN16653 CN16692

(e) omit from the column headed “Number of Repeats”: CN5661 CN5771

(f) insert in numerical order in the column headed “Number of Repeats”: CN16653 CN16692

[92] Schedule 1, Part 1, entries for Nivolumab

(a) omit from the column headed “Circumstances” (all instances): C14676

(b) insert in numerical order in the column headed “Circumstances” (all instances): C16657

[93] Schedule 1, Part 1, entries for Norethisterone with ethinylestradiol

omit from the column headed “Authorised Prescriber” (all instances): MP NP substitute (all instances): MP MW NP

[94] Schedule 1, Part 1, entries for Olanzapine in the form Tablet 10 mg

omit:

Olanzapine

Tablet 10 mg

Oral

Olanzapine APOTEX

MP NP

C4246 C5869

[95] Schedule 1, Part 1, entries for Olsalazine

omit from the column headed “Circumstances” (all instances): C4824 substitute (all instances): C16658

[96] Schedule 1, Part 1, entries for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

omit:

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

[97] Schedule 1, Part 1, entries for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

omit:

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

[98] Schedule 1, Part 1, entries for Ondansetron in the form Tablet (orally disintegrating) 8 mg

omit:

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

[99] Schedule 1, Part 1, entry for Opicapone

omit from the column headed “Circumstances”: C5133 substitute: C16651

[100] Schedule 1, Part 1, entry for Oxcarbazepine in the form Oral suspension 60 mg per mL, 250 mL [Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5183 substitute: C16521

(b) omit from the column headed “Purposes”: P5183 substitute: P16521

[101] Schedule 1, Part 1, entry for Oxcarbazepine in the form Oral suspension 60 mg per mL, 250 mL [Maximum Quantity: 4; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14932 substitute: C16584

(b) omit from the column headed “Purposes”: P14932 substitute: P16584

[102] Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 150 mg [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5183 substitute: C16521

(b) omit from the column headed “Purposes”: P5183 substitute: P16521

[103] Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 150 mg [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14932 substitute: C16584

(b) omit from the column headed “Purposes”: P14932 substitute: P16584

[104] Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 300 mg [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5183 substitute: C16521

(b) omit from the column headed “Purposes”: P5183 substitute: P16521

[105] Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 300 mg [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14932 substitute: C16584

(b) omit from the column headed “Purposes”: P14932 substitute: P16584

[106] Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 600 mg [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5183 substitute: C16521

(b) omit from the column headed “Purposes”: P5183 substitute: P16521

[107] Schedule 1, Part 1, entry for Oxcarbazepine in the form Tablet 600 mg [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14932 substitute: C16584

(b) omit from the column headed “Purposes”: P14932 substitute: P16584

[108] Schedule 1, Part 1, after entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release) [Brand: OxyContin; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg

Oral

ARX-Oxycodone/Naloxone 2.5/1.25

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg

Oral

ARX-Oxycodone/Naloxone 2.5/1.25

MP NP

C11753

P11753

V11753

[109] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg [Brand: Targin 2.5/1.25 mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

Oral

ARX-Oxycodone/Naloxone 5/2.5

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg

Oral

ARX-Oxycodone/Naloxone 5/2.5

MP NP

C11753

P11753

V11753

[110] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg [Brand: Targin 5/2.5mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg

Oral

ARX-Oxycodone/Naloxone 10/5

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg

Oral

ARX-Oxycodone/Naloxone 10/5

MP NP

C11753

P11753

V11753

[111] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg [Brand: Targin 10/5mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg

Oral

ARX-Oxycodone/Naloxone 15/7.5

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg

Oral

ARX-Oxycodone/Naloxone 15/7.5

MP NP

C11753

P11753

V11753

[112] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg [Brand: Targin 15/7.5mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg

Oral

ARX-Oxycodone/Naloxone 20/10

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg

Oral

ARX-Oxycodone/Naloxone 20/10

MP NP

C11753

P11753

V11753

[113] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg [Brand: Targin 20/10mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

Oral

ARX-Oxycodone/Naloxone 30/15

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg

Oral

ARX-Oxycodone/Naloxone 30/15

MP NP

C11753

P11753

V11753

[114] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg [Brand: Targin 30/15 mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg

Oral

ARX-Oxycodone/Naloxone 40/20

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg

Oral

ARX-Oxycodone/Naloxone 40/20

MP NP

C11753

P11753

V11753

[115] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg [Brand: Targin 40/20mg; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg

Oral

ARX-Oxycodone/Naloxone 60/30

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg

Oral

ARX-Oxycodone/Naloxone 60/30

MP NP

C11753

P11753

V11753

[116] Schedule 1, Part 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg [Brand: Targin 60/30; Maximum Quantity: 56; Number of Repeats: 0]

insert:

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg

Oral

ARX-Oxycodone/Naloxone 80/40

MP NP

C10748 C10752 C10755

P10748 P10752 P10755

V10748 V10752 V10755

Oxycodone with naloxone

Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg

Oral

ARX-Oxycodone/Naloxone 80/40

MP NP

C11753

P11753

V11753

[117] Schedule 1, Part 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 15 mg in 5 mL [Maximum Quantity: 4; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C4877 substitute: C16577

(b) omit from the column headed “Purposes”: P4877 substitute: P16577

[118] Schedule 1, Part 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 30 mg in 10 mL [Maximum Quantity: 2; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C4877 substitute: C16577

(b) omit from the column headed “Purposes”: P4877 substitute: P16577

[119] Schedule 1, Part 1, entry for Pamidronic acid in the form Concentrated injection containing pamidronate disodium 60 mg in 10 mL [Maximum Quantity: 1; Number of Repeats: 0]

(a) omit from the column headed “Circumstances”: C4877 substitute: C16577

(b) omit from the column headed “Purposes”: P4877 substitute: P16577

[120] Schedule 1, Part 1, entries for Pancreatic extract

substitute:

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity

Oral

Creon 10,000

MP NP

C16559

P16559

500

100

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity

Oral

Creon 10,000

MP NP

C16508

P16508

1000

100

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

Oral

Creon 25,000

MP NP

C16559

P16559

200

100

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity

Oral

Creon 25,000

MP NP

C16508

P16508

400

100

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 35,000 BP units of lipase activity

Oral

Creon 35,000

MP NP

C16559

P16559

200

100

Pancreatic extract

Capsule (containing enteric coated minimicrospheres) providing not less than 35,000 BP units of lipase activity

Oral

Creon 35,000

MP NP

C16508

P16508

400

100

Pancreatic extract

Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g

Oral

Creon Micro

MP NP

C16559

P16559

Pancreatic extract

Granules (enteric coated) providing not less than 5,000 BP units of lipase activity per 100 mg, 20 g

Oral

Creon Micro

MP NP

C16508

P16508

[121] Schedule 1, Part 1, entries for Paracetamol in the form Tablet 665 mg (modified release)

substitute:

Paracetamol

Tablet 665 mg (modified release)

Oral

APOHEALTH Osteo Relief Paracetamol 665 mg

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

APOHEALTH Osteo Relief Paracetamol 665 mg

MP NP

C6280

P6280

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Chemists' Own Osteo Relief Paracetamol

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Chemists' Own Osteo Relief Paracetamol

MP NP

C6280

P6280

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Osteomol 665 Paracetamol

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Osteomol 665 Paracetamol

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Osteomol 665 Paracetamol

MP NP

C6280

P6280

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Osteomol 665 Paracetamol

MP NP

C6280

P6280

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Parapane OSTEO

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Parapane OSTEO

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Parapane OSTEO

MP NP

C6280

P6280

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Parapane OSTEO

MP NP

C6280

P6280

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Pharmacy Action Paracetamol Osteo 665

MP NP

C6225

P6225

192

Paracetamol

Tablet 665 mg (modified release)

Oral

Pharmacy Action Paracetamol Osteo 665

MP NP

C6280

P6280

192

[122] Schedule 1, Part 1, entries for Phenobarbital in each of the forms: Injection 200 mg (as sodium) in 1 mL; and Tablet 30 mg

omit from the column headed “Circumstances”: C6295 substitute: C16520

[123] Schedule 1, Part 1, entries for Phenoxybenzamine in each of the forms: Capsule containing phenoxybenzamine hydrochloride 10 mg; and Capsules containing phenoxybenzamine hydrochloride 10 mg, 30

omit from the column headed “Circumstances”: C6145 C6178 substitute: C16499 C16567

[124] Schedule 1, Part 1, entry for Phenytoin in the form Capsule containing phenytoin sodium 30 mg [Maximum Quantity: 200; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[125] Schedule 1, Part 1, entry for Phenytoin in the form Capsule containing phenytoin sodium 30 mg [Maximum Quantity: 400; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[126] Schedule 1, Part 1, entry for Phenytoin in the form Capsule containing phenytoin sodium 100 mg [Maximum Quantity: 200; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[127] Schedule 1, Part 1, entry for Phenytoin in the form Capsule containing phenytoin sodium 100 mg [Maximum Quantity: 400; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[128] Schedule 1, Part 1, entry for Phenytoin in the form Oral suspension 30 mg per 5 mL, 500 mL [Maximum Quantity: 1; Number of Repeats: 3]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[129] Schedule 1, Part 1, entry for Phenytoin in the form Oral suspension 30 mg per 5 mL, 500 mL [Maximum Quantity: 2; Number of Repeats: 3]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[130] Schedule 1, Part 1, entry for Phenytoin in the form Tablet 50 mg [Maximum Quantity: 200; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[131] Schedule 1, Part 1, entry for Phenytoin in the form Tablet 50 mg [Maximum Quantity: 400; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[132] Schedule 1, Part 1, entries for Pramipexole

substitute:

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 375 micrograms

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 750 micrograms

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 1.5 mg

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 2.25 mg

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3 mg

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 3.75 mg

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

APO-Pramipexole ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

APO-Pramipexole ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

Sifrol ER

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

Sifrol ER

MP NP

C16540

P16540

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

SIMIPEX XR

MP NP

C16536

P16536

Pramipexole

Tablet (extended release) containing pramipexole dihydrochloride monohydrate 4.5 mg

Oral

SIMIPEX XR

MP NP

C16540

P16540

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

APO-Pramipexole

MP NP

C16536

P16536

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

APO-Pramipexole

MP NP

C5411

P5411

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Sifrol

MP NP

C16536

P16536

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Sifrol

MP NP

C5411

P5411

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simipex 0.125

MP NP

C16536

P16536

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simipex 0.125

MP NP

C5411

P5411

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simpral

MP NP

C16536

P16536

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 125 micrograms

Oral

Simpral

MP NP

C5411

P5411

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole

MP NP

C5411

P5411

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

APO-Pramipexole

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Sifrol

MP NP

C5411

P5411

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Sifrol

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Sifrol

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simipex 0.25

MP NP

C5411

P5411

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simipex 0.25

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simipex 0.25

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simpral

MP NP

C5411

P5411

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simpral

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 250 micrograms

Oral

Simpral

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1mg

Oral

APO-Pramipexole

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

APO-Pramipexole

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Sifrol

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Sifrol

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simipex 1

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simipex 1

MP NP

C16540

P16540

200

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simpral

MP NP

C16536

P16536

100

Pramipexole

Tablet containing pramipexole dihydrochloride monohydrate 1 mg

Oral

Simpral

MP NP

C16540

P16540

200

100

[133] Schedule 1, Part 1, entry for Prednisolone in the form Enema, retention, 20 mg (as sodium phosphate) in 100 mL

insert in the column headed “Circumstances”: C16524

[134] Schedule 1, Part 1, entry for Prednisolone in the form Suppositories 5 mg (as sodium phosphate), 10

omit from the column headed “Circumstances”: C4872 C4893 substitute: C16552 C16673

[135] Schedule 1, Part 1, entry for Primidone

insert in the column headed “Circumstances”: C16524

[136] Schedule 1, Part 1, entry for Propylthiouracil [Maximum Quantity: 200; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16559

(b) insert in the column headed “Purposes”: P16559

[137] Schedule 1, Part 1, entry for Propylthiouracil [Maximum Quantity: 400; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16508

(b) omit from the column headed “Purposes”: P14238 substitute: P16508

[138] Schedule 1, Part 1, entries for Ramipril in the form Capsule 10 mg

omit:

Ramipril

Capsule 10 mg

Oral

Ramipril Winthrop

MP NP

Ramipril

Capsule 10 mg

Oral

Ramipril Winthrop

MP NP

P14238

[139] Schedule 1, Part 1, after entry for Ranitidine in the form Tablet 150 mg (as hydrochloride)

insert:

Ranitidine

Tablet 150 mg (as hydrochloride)

Oral

Zantac 150

MP MW NP

[140] Schedule 1, Part 1, after entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)

insert:

Ranitidine

Tablet 300 mg (as hydrochloride)

Oral

Zantac 300

MP MW NP

[141] Schedule 1, Part 1, entry for Risedronic acid in the form Tablet containing risedronate sodium 30 mg

omit from the column headed “Circumstances”: C4877 substitute: C16577

[142] Schedule 1, Part 1, entries for Rivastigmine

substitute:

Rivastigmine

Capsule 1.5 mg (as hydrogen tartrate)

Oral

Exelon

MP NP

C13938 C13940 C13941

Rivastigmine

Capsule 3 mg (as hydrogen tartrate)

Oral

Exelon

MP NP

C13938 C13940 C13941

Rivastigmine

Capsule 4.5 mg (as hydrogen tartrate)

Oral

Exelon

MP NP

C13938 C13940 C13941

Rivastigmine

Capsule 6 mg (as hydrogen tartrate)

Oral

Exelon

MP NP

C13938 C13940 C13941

Rivastigmine

Transdermal patch 9 mg

Transdermal

Exelon Patch 5

MP NP

C13938 C13940 C13941

Rivastigmine

Transdermal patch 18 mg

Transdermal

Exelon Patch 10

MP NP

C13938 C13940 C13941

Rivastigmine

Transdermal patch 27 mg

Transdermal

Exelon Patch 15

MP NP

C13938 C13940 C13941

[143] Schedule 1, Part 1, entries for Rizatriptan

omit from the column headed “Circumstances” (all instances): C5708 substitute (all instances): C5141

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

omit:

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Rosuvastatin APOTEX

MP NP

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

Rosuvastatin APOTEX

MP NP

P14238

[145] Schedule 1, Part 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15779

(b) omit from the column headed “Purposes”: P15779

[146] Schedule 1, Part 1, entry for Selegiline [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5338 substitute: C16541

(b) omit from the column headed “Purposes”: P5338 substitute: P16541

[147] Schedule 1, Part 1, entry for Selegiline [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15700 substitute: C16538

(b) omit from the column headed “Purposes”: P15700 substitute: P16538

[148] Schedule 1, Part 1, entries for Semaglutide

omit:

Semaglutide

Solution for injection 2 mg in 1.5 mL pre-filled pen

Injection

Ozempic

MP NP

C15263 C15301

[149] Schedule 1, Part 1, after entry for Selumetinib in the form Capsule 25 mg

insert:

Semaglutide

Solution for injection 2 mg in 3 mL pre-filled pen

Injection

Ozempic

MP NP

C15263 C15301

[150] Schedule 1, Part 1, entry for Sulfasalazine in the form Tablet 500 mg [Maximum Quantity: 200; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[151] Schedule 1, Part 1, entry for Sulfasalazine in the form Tablet 500 mg [Maximum Quantity: 400; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[152] Schedule 1, Part 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated) [Brand: Pyralin EN; Maximum Quantity: 200; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[153] Schedule 1, Part 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated) [Brand: Pyralin EN; Maximum Quantity: 400; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[154] Schedule 1, Part 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated) [Brand: Salazopyrin-EN; Maximum Quantity: 200; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[155] Schedule 1, Part 1, entry for Sulfasalazine in the form Tablet 500 mg (enteric coated) [Brand: Salazopyrin-EN; Maximum Quantity: 400; Number of Repeats: 5]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[156] Schedule 1, Part 1, entry for Sulthiame in the form Tablet 50 mg [Maximum Quantity: 200; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[157] Schedule 1, Part 1, entry for Sulthiame in the form Tablet 50 mg [Maximum Quantity: 400; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[158] Schedule 1, Part 1, entry for Sulthiame in the form Tablet 200 mg [Maximum Quantity: 200; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”: C16524

(b) insert in the column headed “Purposes”: P16524

[159] Schedule 1, Part 1, entry for Sulthiame in the form Tablet 200 mg [Maximum Quantity: 400; Number of Repeats: 2]

(a) insert in the column headed “Circumstances”:C16493

(b) omit from the column headed “Purposes”: P14238 substitute: P16493

[160] Schedule 1, Part 1, entries for Sumatriptan

omit from the column headed “Circumstances” (all instances): C5259 substitute (all instances): C5141

[161] Schedule 1, Part 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Genox 20; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6421 substitute: C16579

(b) omit from the column headed “Purposes”: P6421 substitute: P16579

[162] Schedule 1, Part 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Genox 20; Maximum Quantity: 60; Number of Repeats: 5; Pack Quantity: 30]

(a) omit from the column headed “Circumstances”: C14989 substitute: C16664

(b) omit from the column headed “Purposes”: P14989 substitute: P16664

[163] Schedule 1, Part 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Nolvadex-D; Maximum Quantity: 30; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6421 substitute: C16579

(b) omit from the column headed “Purposes”: P6421 substitute: P16579

[164] Schedule 1, Part 1, entry for Tamoxifen in the form Tablet 20 mg (as citrate) [Brand: Nolvadex-D; Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14989

(b) insert in numerical order in the column headed “Circumstances”: C16664

(d) insert in numerical order in the column headed “Purposes”: P16664

[165] Schedule 1, Part 1, entry for Temazepam in the form Tablet 10 mg [Brand: APO-Temazepam; Maximum Quantity: 50; Number of Repeats: 5]

substitute:

Temazepam

Tablet 10 mg

Oral

APO-Temazepam

MP NP

P5941 P5950 P16692

50
CN5941 CN5950 CN16692

5
CN5941 CN5950 CN16692

[166] Schedule 1, Part 1, entry for Temazepam in the form Tablet 10 mg [Brand: Normison; Maximum Quantity: 50; Number of Repeats: 5]

substitute:

Temazepam

Tablet 10 mg

Oral

Normison

MP NP

P5941 P5950 P16692

50
CN5941 CN5950 CN16692

5
CN5941 CN5950 CN16692

[167] Schedule 1, Part 1, entry for Temazepam in the form Tablet 10 mg [Brand: Temaze; Maximum Quantity: 50; Number of Repeats: 5]

substitute:

Temazepam

Tablet 10 mg

Oral

Temaze

MP NP

P5941 P5950 P16692

50
CN5941 CN5950 CN16692

5
CN5941 CN5950 CN16692

[168] Schedule 1, Part 1, entry for Temazepam in the form Tablet 10 mg [Brand: TEMAZEPAM-WGR; Maximum Quantity: 50; Number of Repeats: 5]

substitute:

Temazepam

Tablet 10 mg

Oral

TEMAZEPAM-WGR

MP NP

P5941 P5950 P16692

50
CN5941 CN5950 CN16692

5
CN5941 CN5950 CN16692

[169] Schedule 1, Part 1, entry for Temazepam in the form Tablet 10 mg [Brand: Temtabs; Maximum Quantity: 50; Number of Repeats: 5]

substitute:

Temazepam

Tablet 10 mg

Oral

Temtabs

MP NP

P5941 P5950 P16692

50
CN5941 CN5950 CN16692

5
CN5941 CN5950 CN16692

[170] Schedule 1, Part 1, entry for Tetrabenazine [Brand: iNova Pharmaceuticals (Australia) Pty Ltd; Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5340 substitute: C16537

(b) omit from the column headed “Purposes”: P5340 substitute: P16537

[171] Schedule 1, Part 1, entry for Tetrabenazine [Brand: iNova Pharmaceuticals (Australia) Pty Ltd; Maximum Quantity: 224; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15673 substitute: C16699

(b) omit from the column headed “Purposes”: P15673 substitute: P16699

[172] Schedule 1, Part 1, entry for Tetrabenazine [Brand: Tetrabenazine SUN; Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C5340 substitute: C16537

(b) omit from the column headed “Purposes”: P5340 substitute: P16537

[173] Schedule 1, Part 1, entry for Tetrabenazine [Brand: Tetrabenazine SUN; Maximum Quantity: 224; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C15673 substitute: C16699

(b) omit from the column headed “Purposes”: P15673 substitute: P16699

[174] Schedule 1, Part 1, entry for Tiagabine in the form Tablet 5 mg (as hydrochloride) [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4928 substitute: C16515

(b) omit from the column headed “Purposes”: P4928 substitute: P16515

[175] Schedule 1, Part 1, entry for Tiagabine in the form Tablet 5 mg (as hydrochloride) [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14883 substitute: C16526

(b) omit from the column headed “Purposes”: P14883 substitute: P16526

[176] Schedule 1, Part 1, entry for Tiagabine in the form Tablet 10 mg (as hydrochloride) [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4928 substitute: C16515

(b) omit from the column headed “Purposes”: P4928 substitute: P16515

[177] Schedule 1, Part 1, entry for Tiagabine in the form Tablet 10 mg (as hydrochloride) [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14883 substitute: C16526

(b) omit from the column headed “Purposes”: P14883 substitute: P16526

[178] Schedule 1, Part 1, entry for Tiagabine in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4928 substitute: C16515

(b) omit from the column headed “Purposes”: P4928 substitute: P16515

[179] Schedule 1, Part 1, entry for Tiagabine in the form Tablet 15 mg (as hydrochloride) [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14883 substitute: C16526

(b) omit from the column headed “Purposes”: P14883 substitute: P16526

[180] Schedule 1, Part 1, entries for Tiotropium

substitute:

Tiotropium

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

Braltus

MP NP

C6352

P6352

Tiotropium

Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)

Inhalation by mouth

Braltus

MP NP

C15611

P15611

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

Inhalation by mouth

Spiriva

MP NP

C6352

P6352

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in HandiHaler)

Inhalation by mouth

Spiriva

MP NP

C15611

P15611

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)

Inhalation by mouth

Tiotropium Lupin

MP NP

C6352

P6352

Tiotropium

Capsule containing powder for oral inhalation 18 micrograms (as bromide monohydrate) (for use in LupinHaler)

Inhalation by mouth

Tiotropium Lupin

MP NP

C15611

P15611

Tiotropium

Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations)

Inhalation by mouth

Spiriva Respimat

MP NP

C5509 C8606 C12599

Tiotropium

Solution for oral inhalation 2.5 micrograms (as bromide monohydrate) per actuation (60 actuations), pack of 2

Inhalation by mouth

Spiriva Respimat

MP NP

C15566 C15753 C15754

[181] Schedule 1, Part 1, entries for Tiotropium with olodaterol

substitute:

Tiotropium with olodaterol

Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses

Inhalation by mouth

Spiolto Respimat

MP NP

C7798

Tiotropium with olodaterol

Solution for oral inhalation containing tiotropium 2.5 micrograms (as bromide monohydrate) with olodaterol 2.5 micrograms (as hydrochloride) per dose, 60 doses, pack of 2

Inhalation by mouth

Spiolto Respimat

MP NP

C15691

[182] Schedule 1, Part 1, entries for Topiramate

substitute:

Topiramate

Capsule 15 mg

Oral

Topamax Sprinkle

MP NP

C16586

P16586

Topiramate

Capsule 15 mg

Oral

Topamax Sprinkle

MP NP

C16619

P16619

120

Topiramate

Capsule 25 mg

Oral

Topamax Sprinkle

MP NP

C16586

P16586

Topiramate

Capsule 25 mg

Oral

Topamax Sprinkle

MP NP

C16619

P16619

120

Topiramate

Capsule 50 mg

Oral

Topamax Sprinkle

MP NP

C16586

P16586

Topiramate

Capsule 50 mg

Oral

Topamax Sprinkle

MP NP

C16619

P16619

120

Topiramate

Tablet 25 mg

Oral

APO-Topiramate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 25 mg

Oral

APO-Topiramate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 25 mg

Oral

Epiramax 25

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 25 mg

Oral

Epiramax 25

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 25 mg

Oral

RBX Topiramate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 25 mg

Oral

RBX Topiramate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 25 mg

Oral

Tamate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 25 mg

Oral

Tamate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 25 mg

Oral

Topiramate Sandoz

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 25 mg

Oral

Topiramate Sandoz

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 25 mg

Oral

TOPIRAMATE-WGR

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 25 mg

Oral

TOPIRAMATE-WGR

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 50 mg

Oral

APO-Topiramate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 50 mg

Oral

APO-Topiramate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 50 mg

Oral

Epiramax 50

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 50 mg

Oral

Epiramax 50

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 50 mg

Oral

RBX Topiramate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 50 mg

Oral

RBX Topiramate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 50 mg

Oral

Tamate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 50 mg

Oral

Tamate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 50 mg

Oral

Topiramate Sandoz

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 50 mg

Oral

Topiramate Sandoz

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 50 mg

Oral

TOPIRAMATE-WGR

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 50 mg

Oral

TOPIRAMATE-WGR

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 100 mg

Oral

APO-Topiramate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 100 mg

Oral

APO-Topiramate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 100 mg

Oral

Epiramax 100

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 100 mg

Oral

Epiramax 100

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 100 mg

Oral

RBX Topiramate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 100 mg

Oral

RBX Topiramate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 100 mg

Oral

Tamate

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 100 mg

Oral

Tamate

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 100 mg

Oral

Topiramate Sandoz

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 100 mg

Oral

Topiramate Sandoz

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 100 mg

Oral

TOPIRAMATE-WGR

MP NP

C5325 C16525

P5325 P16525

Topiramate

Tablet 100 mg

Oral

TOPIRAMATE-WGR

MP NP

C14901 C16589

P14901 P16589

120

Topiramate

Tablet 200 mg

Oral

APO-Topiramate

MP NP

C16525

P16525

Topiramate

Tablet 200 mg

Oral

APO-Topiramate

MP NP

C16589

P16589

120

Topiramate

Tablet 200 mg

Oral

Epiramax 200

MP NP

C16525

P16525

Topiramate

Tablet 200 mg

Oral

Epiramax 200

MP NP

C16589

P16589

120

Topiramate

Tablet 200 mg

Oral

RBX Topiramate

MP NP

C16525

P16525

Topiramate

Tablet 200 mg

Oral

RBX Topiramate

MP NP

C16589

P16589

120

Topiramate

Tablet 200 mg

Oral

Tamate

MP NP

C16525

P16525

Topiramate

Tablet 200 mg

Oral

Tamate

MP NP

C16589

P16589

120

Topiramate

Tablet 200 mg

Oral

Topiramate Sandoz

MP NP

C16525

P16525

Topiramate

Tablet 200 mg

Oral

Topiramate Sandoz

MP NP

C16589

P16589

120

Topiramate

Tablet 200 mg

Oral

TOPIRAMATE-WGR

MP NP

C16525

P16525

Topiramate

Tablet 200 mg

Oral

TOPIRAMATE-WGR

MP NP

C16589

P16589

120

[183] Schedule 1, Part 1, entries for Ursodeoxycholic acid

omit from the column headed “Circumstances” (all instances): C9032 substitute (all instances): C16558

[184] Schedule 1, Part 1, entries for Valproic acid

substitute:

Valproic acid

Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Liquid

MP NP

C16524

P16524

Valproic acid

Oral liquid containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Liquid

MP NP

C16493

P16493

Valproic acid

Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Syrup

MP NP

C16524

P16524

Valproic acid

Oral solution containing sodium valproate 200 mg per 5 mL, 300 mL

Oral

Epilim Syrup

MP NP

C16493

P16493

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

APO-Sodium Valproate

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

APO-Sodium Valproate

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Epilim EC

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Epilim EC

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Sodium Valproate Sandoz

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Sodium Valproate Sandoz

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valpro EC 200

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valpro EC 200

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valproate Winthrop EC 200

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valproate Winthrop EC 200

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

APO-Sodium Valproate

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

APO-Sodium Valproate

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Epilim EC

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Epilim EC

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Sodium Valproate Sandoz

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Sodium Valproate Sandoz

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valpro EC 500

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valpro EC 500

MP NP

C16493

P16493

400

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valproate Winthrop EC 500

MP NP

C16524

P16524

200

100

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valproate Winthrop EC 500

MP NP

C16493

P16493

400

100

Valproic acid

Tablet, crushable, containing sodium valproate 100 mg

Oral

Epilim

MP NP

C16524

P16524

200

100

Valproic acid

Tablet, crushable, containing sodium valproate 100 mg

Oral

Epilim

MP NP

C16493

P16493

400

100

[185] Schedule 1, Part 1, entries for Vericiguat

substitute:

Vericiguat

Tablet 2.5 mg

Oral

Verquvo

MP NP

C13561 C16562

Vericiguat

Tablet 5 mg

Oral

Verquvo

MP NP

C13561 C16562

Vericiguat

Tablet 10 mg

Oral

Verquvo

MP NP

C13561 C16562

[186] Schedule 1, Part 1, entry for Vigabatrin in the form Oral powder, sachet 500 mg [Maximum Quantity: 60; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4929 substitute: C16669

(b) omit from the column headed “Purposes”: P4929 substitute: P16669

[187] Schedule 1, Part 1, entry for Vigabatrin in the form Oral powder, sachet 500 mg [Maximum Quantity: 120; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14903 substitute: C16648

(b) omit from the column headed “Purposes”: P14903 substitute: P16648

[188] Schedule 1, Part 1, entry for Vigabatrin in the form Tablet 500 mg [Maximum Quantity: 100; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4929 substitute: C16669

(b) omit from the column headed “Purposes”: P4929 substitute: P16669

[189] Schedule 1, Part 1, entry for Vigabatrin in the form Tablet 500 mg [Maximum Quantity: 200; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14903 substitute: C16648

(b) omit from the column headed “Purposes”: P14903 substitute: P16648

[190] Schedule 1, Part 1, entries for Zolmitriptan

omit from the column headed “Circumstances” (all instances): C5489 substitute (all instances): C5141

[191] Schedule 1, Part 1, entry for Zonisamide in the form Capsule 25 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4928 substitute: C16515

(b) omit from the column headed “Purposes”: P4928 substitute: P16515

[192] Schedule 1, Part 1, entry for Zonisamide in the form Capsule 25 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14883 substitute: C16526

(b) omit from the column headed “Purposes”: P14883 substitute: P16526

[193] Schedule 1, Part 1, entry for Zonisamide in the form Capsule 50 mg [Maximum Quantity: 56; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4928 substitute: C16515

(b) omit from the column headed “Purposes”: P4928 substitute: P16515

[194] Schedule 1, Part 1, entry for Zonisamide in the form Capsule 50 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14883 substitute: C16526

(b) omit from the column headed “Purposes”: P14883 substitute: P16526

[195] Schedule 1, Part 1, entry for Zonisamide in the form Capsule 100 mg [Maximum Quantity: 112; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C4928 substitute: C16515

(b) omit from the column headed “Purposes”: P4928 substitute: P16515

[196] Schedule 1, Part 1, entry for Zonisamide in the form Capsule 100 mg [Maximum Quantity: 224; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C14883 substitute: C16526

(b) omit from the column headed “Purposes”: P14883 substitute: P16526

[197] Schedule 1, Part 2, omit entry for Evolocumab

[198] Schedule 1, Part 2, after entry for Ramipril with felodipine

insert:

Semaglutide

Solution for injection 2 mg in 1.5 mL pre-filled pen

Injection

Ozempic

[199] Schedule 3, entry for Responsible Person code RB

omit from the column headed “Responsible Person”: Bio Revive Pty Ltd substitute: SUBSTANCE PTY LTD

[200] Schedule 4, Part 1, omit entry for Circumstances Code “C4150”

[201] Schedule 4, Part 1, omit entry for Circumstances Code “C4158”

[202] Schedule 4, Part 1, omit entry for Circumstances Code “C4504”

[203] Schedule 4, Part 1, omit entry for Circumstances Code “C4824”

[204] Schedule 4, Part 1, omit entry for Circumstances Code “C4872”

[205] Schedule 4, Part 1, omit entry for Circumstances Code “C4877”

[206] Schedule 4, Part 1, omit entry for Circumstances Code “C4878”

[207] Schedule 4, Part 1, omit entry for Circumstances Code “C4888”

[208] Schedule 4, Part 1, omit entry for Circumstances Code “C4893”

[209] Schedule 4, Part 1, omit entry for Circumstances Code “C4922”

[210] Schedule 4, Part 1, omit entry for Circumstances Code “C4928”

[211] Schedule 4, Part 1, omit entry for Circumstances Code “C4929”

[212] Schedule 4, Part 1, omit entry for Circumstances Code “C5131”

[213] Schedule 4, Part 1, omit entry for Circumstances Code “C5132”

[214] Schedule 4, Part 1, omit entry for Circumstances Code “C5133”

[215] Schedule 4, Part 1, entry for Circumstances Code “C5141”

(a) insert in alphabetical order in the column headed “Listed Drug”: Rizatriptan

(b) insert in alphabetical order in the column headed “Listed Drug”: Sumatriptan

[216] Schedule 4, Part 1, omit entry for Circumstances Code “C5168”

[217] Schedule 4, Part 1, omit entry for Circumstances Code “C5173”

[218] Schedule 4, Part 1, omit entry for Circumstances Code “C5183”

[219] Schedule 4, Part 1, omit entry for Circumstances Code “C5212”

[220] Schedule 4, Part 1, omit entry for Circumstances Code “C5253”

[221] Schedule 4, Part 1, omit entry for Circumstances Code “C5259”

[222] Schedule 4, Part 1, omit entry for Circumstances Code “C5288”

[223] Schedule 4, Part 1, omit entry for Circumstances Code “C5338”

[224] Schedule 4, Part 1, omit entry for Circumstances Code “C5340”

[225] Schedule 4, Part 1, omit entry for Circumstances Code “C5363”

[226] Schedule 4, Part 1, omit entry for Circumstances Code “C5489”

[227] Schedule 4, Part 1, omit entry for Circumstances Code “C5516”

[228] Schedule 4, Part 1, omit entry for Circumstances Code “C5661”

[229] Schedule 4, Part 1, omit entry for Circumstances Code “C5708”

[230] Schedule 4, Part 1, omit entry for Circumstances Code “C5771”

[231] Schedule 4, Part 1, omit entry for Circumstances Code “C6145”

[232] Schedule 4, Part 1, omit entry for Circumstances Code “C6178”

[233] Schedule 4, Part 1, omit entry for Circumstances Code “C6226”

[234] Schedule 4, Part 1, omit entry for Circumstances Code “C6227”

[235] Schedule 4, Part 1, omit entry for Circumstances Code “C6295”

[236] Schedule 4, Part 1, omit entry for Circumstances Code “C6296”

[237] Schedule 4, Part 1, omit entry for Circumstances Code “C6382”

[238] Schedule 4, Part 1, omit entry for Circumstances Code “C6410”

[239] Schedule 4, Part 1, omit entry for Circumstances Code “C6421”

[240] Schedule 4, Part 1, omit entry for Circumstances Code “C7621”

[241] Schedule 4, Part 1, omit entry for Circumstances Code “C8777”

[242] Schedule 4, Part 1, omit entry for Circumstances Code “C8778”

[243] Schedule 4, Part 1, omit entry for Circumstances Code “C9032”

[244] Schedule 4, Part 1, omit entry for Circumstances Code “C9443”

[245] Schedule 4, Part 1, omit entry for Circumstances Code “C9444”

[246] Schedule 4, Part 1, omit entry for Circumstances Code “C11077”

[247] Schedule 4, Part 1, omit entry for Circumstances Code “C11081”

[248] Schedule 4, Part 1, omit entry for Circumstances Code “C11116”

[249] Schedule 4, Part 1, omit entry for Circumstances Code “C12607”

[250] Schedule 4, Part 1, omit entry for Circumstances Code “C13562”

[251] Schedule 4, Part 1, omit entry for Circumstances Code “C13886”

[252] Schedule 4, Part 1, omit entry for Circumstances Code “C13913”

[253] Schedule 4, Part 1, omit entry for Circumstances Code “C14229”

[254] Schedule 4, Part 1, entry for Circumstances Code “C14238”

(a) omit from the column headed “Listed Drug”: Carbamazepine

(b) omit from the column headed “Listed Drug”: Carbimazole

(d) omit from the column headed “Listed Drug”: Ethosuximide

(e) omit from the column headed “Listed Drug”: Hydrocortisone

(f) omit from the column headed “Listed Drug”: Levodopa with benserazide

(g) omit from the column headed “Listed Drug”: Levodopa with carbidopa

(h) omit from the column headed “Listed Drug”: Pancreatic extract

(i) omit from the column headed “Listed Drug”: Phenytoin

(j) omit from the column headed “Listed Drug”: Propylthiouracil

(k) omit from the column headed “Listed Drug”: Sulfasalazine

(l) omit from the column headed “Listed Drug”: Sulthiame

(m) omit from the column headed “Listed Drug”: Valproic acid

[255] Schedule 4, Part 1, omit entry for Circumstances Code “C14260”

[256] Schedule 4, Part 1, omit entry for Circumstances Code “C14306”

[257] Schedule 4, Part 1, omit entry for Circumstances Code “C14676”

[258] Schedule 4, Part 1, omit entry for Circumstances Code “C14843”

[259] Schedule 4, Part 1, omit entry for Circumstances Code “C14844”

[260] Schedule 4, Part 1, omit entry for Circumstances Code “C14855”

[261] Schedule 4, Part 1, omit entry for Circumstances Code “C14883”

[262] Schedule 4, Part 1, omit entry for Circumstances Code “C14903”

[263] Schedule 4, Part 1, omit entry for Circumstances Code “C14931”

[264] Schedule 4, Part 1, omit entry for Circumstances Code “C14932”

[265] Schedule 4, Part 1, omit entry for Circumstances Code “C14964”

[266] Schedule 4, Part 1, omit entry for Circumstances Code “C14973”

[267] Schedule 4, Part 1, omit entry for Circumstances Code “C14988”

[268] Schedule 4, Part 1, omit entry for Circumstances Code “C14989”

[269] Schedule 4, Part 1, omit entry for Circumstances Code “C15564”

[270] Schedule 4, Part 1, omit entry for Circumstances Code “C15565”

[271] Schedule 4, Part 1, omit entry for Circumstances Code “C15568”

[272] Schedule 4, Part 1, omit entry for Circumstances Code “C15570”

[273] Schedule 4, Part 1, omit entry for Circumstances Code “C15602”

[274] Schedule 4, Part 1, omit entry for Circumstances Code “C15608”

[275] Schedule 4, Part 1, omit entry for Circumstances Code “C15636”

[276] Schedule 4, Part 1, omit entry for Circumstances Code “C15655”

[277] Schedule 4, Part 1, omit entry for Circumstances Code “C15673”

[278] Schedule 4, Part 1, omit entry for Circumstances Code “C15700”

[279] Schedule 4, Part 1, omit entry for Circumstances Code “C15704”

[280] Schedule 4, Part 1, omit entry for Circumstances Code “C15711”

[281] Schedule 4, Part 1, omit entry for Circumstances Code “C15772”

[282] Schedule 4, Part 1, omit entry for Circumstances Code “C15779”

[283] Schedule 4, Part 1, omit entry for Circumstances Code “C16152”

[284] Schedule 4, Part 1, omit entry for Circumstances Code “C16154”

[285] Schedule 4, Part 1, omit entry for Circumstances Code “C16274”

[286] Schedule 4, Part 1, omit entry for Circumstances Code “C16312”

[287] Schedule 4, Part 1, omit entry for Circumstances Code “C16352”

[288] Schedule 4, Part 1, after entry for Circumstances Code “C16482”

insert:

C16489	P16489	CN16489	Esomeprazole	Scleroderma oesophagus The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16490	P16490	CN16490	Mesalazine	Crohn disease Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16491	P16491	CN16491	Mesalazine	Ulcerative colitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16493	P16493	CN16493	Carbamazepine Ethosuximide Levodopa with benserazide Levodopa with carbidopa Phenytoin Sulfasalazine Sulthiame Valproic acid	The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16499	P16499	CN16499	Phenoxybenzamine	Phaeochromocytoma Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
C16508	P16508	CN16508	Carbimazole Cortisone Hydrocortisone Pancreatic extract Propylthiouracil	The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
C16510	P16510	CN16510	Liothyronine	Hypothyroidism The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for replacement therapy; AND Patient must have documented intolerance to levothyroxine sodium; or Patient must have documented resistance to levothyroxine sodium. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures - Streamlined Authority Code 16510
C16512	P16512	CN16512	Denosumab	Bone metastases The condition must be due to castration-resistant prostate cancer. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16512
C16514	P16514	CN16514	Denosumab	Giant cell tumour of bone Patient must be one in whom surgical resection is not feasible; or Patient must be one in whom surgical resection is possible but surgery would result in significant morbidity. Patient must be an adult; or Patient must be a skeletally mature adolescent. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16514
C16515	P16515	CN16515	Gabapentin Tiagabine Zonisamide	Partial epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16515
C16517	P16517	CN16517	Clonazepam	Epilepsy The condition must be neurologically proven. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures
C16519	P16519	CN16519	Levetiracetam	Partial epileptic seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or Patient must be a woman of childbearing potential; AND Patient must be unable to take a solid dose form of levetiracetam; AND The treatment must not be given concomitantly with brivaracetam, except for cross titration. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16519
C16520	P16520	CN16520	Clonazepam Phenobarbital	Epilepsy Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16521	P16521	CN16521	Oxcarbazepine	Seizures Patient must have partial epileptic seizures; or Patient must have primary generalised tonic-clonic seizures; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16521
C16524	P16524	CN16524	Budesonide Carbamazepine Ethosuximide Levodopa with benserazide Levodopa with carbidopa Phenytoin Prednisolone Primidone Sulfasalazine Sulthiame Valproic acid	For prescribing by certain health practitioners Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16525	P16525	CN16525	Topiramate	Seizures Patient must have partial epileptic seizures; or Patient must have primary generalised tonic-clonic seizures; or Patient must have seizures of the Lennox-Gastaut syndrome; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16525
C16526	P16526	CN16526	Tiagabine Zonisamide	Partial epileptic seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16526
C16533	P16533	CN16533	Levodopa with carbidopa and entacapone	Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16534	P16534	CN16534	Levodopa with carbidopa and entacapone	Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND Patient must be experiencing fluctuations in motor function due to end-of-dose effect. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16536	P16536	CN16536	Cabergoline Pramipexole	Parkinson disease Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16537	P16537	CN16537	Tetrabenazine	Hyperkinetic extrapyramidal disorders Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16537
C16538	P16538	CN16538	Selegiline	Late stage Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16540	P16540	CN16540	Cabergoline Pramipexole	Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16541	P16541	CN16541	Selegiline	Late stage Parkinson disease The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16545	P16545	CN16545	Methylphenidate	Attention deficit hyperactivity disorder Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND Patient must require continuous coverage over 8 hours; AND The treatment must not exceed a maximum daily dose of 80 mg of PBS-subsidised treatment with this drug. Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; or Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit. A retrospective diagnosis of ADHD for the purposes of administering this restriction is: (i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and (ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above.	Compliance with Authority Required procedures
C16548	P16548	CN16548	Mesalazine	Mild to moderate ulcerative proctitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16551	P16551	CN16551	Balsalazide	Ulcerative colitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have had a documented hypersensitivity reaction to a sulphonamide; or Patient must be intolerant to sulfasalazine. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16551
C16552	P16552	CN16552	Mesalazine Prednisolone	Ulcerative colitis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16555	P16555	CN16555	Esomeprazole	Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16558	P16558	CN16558	Ursodeoxycholic acid	Primary biliary cholangitis (previously known as Primary biliary cirrhosis) Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures - Streamlined Authority Code 16558
C16559	P16559	CN16559	Acetazolamide Carbimazole Cortisone Fludrocortisone Hydrocortisone Lithium Pancreatic extract Propylthiouracil	For prescribing by certain health practitioners Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
C16562	P16562	CN16562	Vericiguat	Chronic heart failure Initial treatment Must be treated by a cardiologist; or Must be treated by an authorised prescriber (medical practitioner, nurse practitioner) who has been directed to prescribe this medicine by a cardiologist. Patient must be symptomatic with NYHA classes II, III or IV; AND Patient must have a documented left ventricular ejection fraction (LVEF) of less than 45%; AND The condition must be stabilised following a decompensation event that required at least one of: (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND Patient must not have clinical signs of fluid overload; AND Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND Patient must not have a systolic blood pressure less than 100 mmHg; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated.	Compliance with Authority Required procedures
C16567	P16567	CN16567	Phenoxybenzamine	Neurogenic urinary retention Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
C16575	P16575	CN16575	Calcitonin salmon	Hypercalcaemia The treatment must be initiated in a hospital; AND The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16577	P16577	CN16577	Pamidronic acid Risedronic acid	Symptomatic Paget disease of bone Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.
C16579	P16579	CN16579	Tamoxifen	Reduction of breast cancer risk Patient must have a moderate or high risk of developing breast cancer; AND The treatment must not exceed a dose of 20 mg per day; AND The treatment must not exceed a lifetime maximum of 5 years for this condition. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16580	P16580	CN16580	Lamotrigine	Epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or Patient must be a woman of childbearing potential. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16580
C16581	P16581	CN16581	Lamotrigine	Epileptic seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or Patient must be a woman of childbearing potential. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16581
C16582	P16582	CN16582	Levetiracetam	Partial epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or Patient must be a woman of childbearing potential; AND The treatment must not be given concomitantly with brivaracetam, except for cross titration. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16582
C16584	P16584	CN16584	Oxcarbazepine	Seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have partial epileptic seizures; or Patient must have primary generalised tonic-clonic seizures; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16584
C16586	P16586	CN16586	Topiramate	Seizures Patient must have partial epileptic seizures; or Patient must have primary generalised tonic-clonic seizures; or Patient must have seizures of the Lennox-Gastaut syndrome; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; AND Patient must be unable to take a solid dose form of topiramate. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16586
C16589	P16589	CN16589	Topiramate	Seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have partial epileptic seizures; or Patient must have primary generalised tonic-clonic seizures; or Patient must have seizures of the Lennox-Gastaut syndrome; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16589
C16591	P16591	CN16591	Levodopa with carbidopa and entacapone	Parkinson disease Patient must be stabilised on concomitant treatment with levodopa decarboxylase inhibitor combinations and entacapone. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16592	P16592	CN16592	Levodopa with carbidopa and entacapone	Parkinson disease Patient must be being treated with levodopa decarboxylase inhibitor combinations; AND Patient must be experiencing fluctuations in motor function due to end-of-dose effect. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16596	P16596	CN16596	Dexamfetamine Methylphenidate	Attention deficit hyperactivity disorder Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit. Treatment must be in accordance with the law of the relevant State or Territory.	Compliance with Authority Required procedures
C16597	P16597	CN16597	Lisdexamfetamine	Attention deficit hyperactivity disorder Patient must require continuous coverage over 12 hours; AND The treatment must not exceed a maximum daily dose of 70 mg of PBS-subsidised treatment with this drug. Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive; or Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit. A retrospective diagnosis of ADHD for the purposes of administering this restriction is: (i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and (ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a: (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above.	Compliance with Authority Required procedures
C16598	P16598	CN16598	Methylphenidate	Attention deficit hyperactivity disorder Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND Patient must require continuous coverage over 12 hours; AND The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug. Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16603	P16603	CN16603	Mesalazine	Crohn disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16607	P16607	CN16607	Liothyronine	Thyroid cancer Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures - Streamlined Authority Code 16607
C16608	P16608	CN16608	Denosumab	Bone metastases The condition must be due to breast cancer. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16608
C16615	P16615	CN16615	Levetiracetam	Partial epileptic seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or Patient must be a woman of childbearing potential; AND The treatment must not be given concomitantly with brivaracetam, except for cross titration. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16615
C16619	P16619	CN16619	Topiramate	Seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have partial epileptic seizures; or Patient must have primary generalised tonic-clonic seizures; or Patient must have seizures of the Lennox-Gastaut syndrome; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; AND Patient must be unable to take a solid dose form of topiramate. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16619
C16621	P16621	CN16621	Amantadine	Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must not be drug induced. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16624	P16624	CN16624	Levodopa with carbidopa	Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16629	P16629	CN16629	Dexamfetamine	Narcolepsy Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16632	P16632	CN16632	Mesalazine	Mild to moderate ulcerative colitis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16632
C16633	P16633	CN16633	Mesalazine	Mild to moderate ulcerative proctitis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16634	P16634	CN16634	Esomeprazole	Scleroderma oesophagus Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16646	P16646	CN16646	Levetiracetam	Partial epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or Patient must be a woman of childbearing potential; AND Patient must be unable to take a solid dose form of levetiracetam; AND The treatment must not be given concomitantly with brivaracetam, except for cross titration. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16646
C16648	P16648	CN16648	Vigabatrin	Epileptic seizures The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16648
C16651	P16651	CN16651	Entacapone Opicapone	Parkinson disease The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND Patient must be experiencing fluctuations in motor function due to end-of-dose effect. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16653	P16653	CN16653	Nitrazepam	Myoclonic epilepsy Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures
C16656	P16656	CN16656	Mesalazine	Mild to moderate ulcerative colitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16656
C16657	P16657	CN16657	Nivolumab	Advanced or metastatic gastro-oesophageal cancers Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND Patient must be untreated (up until initiating this drug) with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer. Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.	Compliance with Authority Required procedures - Streamlined Authority Code 16657
C16658	P16658	CN16658	Balsalazide Olsalazine	Ulcerative colitis Patient must have had a documented hypersensitivity reaction to a sulphonamide; or Patient must be intolerant to sulfasalazine. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16658
C16659	P16659	CN16659	Esomeprazole	Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have symptoms which are inadequately controlled using a standard dose proton pump inhibitor. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16664	P16664	CN16664	Tamoxifen	Reduction of breast cancer risk The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have a moderate or high risk of developing breast cancer; AND The treatment must not exceed a dose of 20 mg per day; AND The treatment must not exceed a lifetime maximum of 5 years for this condition. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16669	P16669	CN16669	Vigabatrin	Epileptic seizures The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16669
C16670	P16670	CN16670	Amantadine	Parkinson disease The condition must not be drug induced. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16673	P16673	CN16673	Prednisolone	Proctitis Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16674	P16674	CN16674	Budesonide	Mild to moderate Crohn disease The condition must affect the ileum; or The condition must affect the ascending colon; or The condition must affect the ileum and ascending colon. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. The total duration of therapy should be no more than 12 weeks in any single course.	Compliance with Authority Required procedures - Streamlined Authority Code 16674
C16676	P16676	CN16676	Liothyronine	Hypothyroidism The treatment must be for replacement therapy; AND Patient must have documented intolerance to levothyroxine sodium; or Patient must have documented resistance to levothyroxine sodium. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures - Streamlined Authority Code 16676
C16678	P16678	CN16678	Calcitonin salmon	Symptomatic Paget disease of bone The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures
C16679	P16679	CN16679	Ibandronic acid	Bone metastases The condition must be due to breast cancer. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16688	P16688	CN16688	Levodopa with carbidopa	Parkinson disease The condition must be one in which fluctuations in motor function are not adequately controlled by frequent dosing with conventional formulations of levodopa with decarboxylase inhibitor. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16690	P16690	CN16690	Entacapone	Parkinson disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be as adjunctive therapy to a levodopa-decarboxylase inhibitor combination; AND Patient must be experiencing fluctuations in motor function due to end-of-dose effect. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16692	P16692	CN16692	Nitrazepam Temazepam	Malignant neoplasia (late stage) Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures
C16695	P16695	CN16695	Budesonide	Mild to moderate Crohn disease The condition must affect the ileum; or The condition must affect the ascending colon; or The condition must affect the ileum and ascending colon. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner. The total duration of therapy should be no more than 10 weeks in any single course.	Compliance with Authority Required procedures - Streamlined Authority Code 16695
C16698	P16698	CN16698	Liothyronine	Thyroid cancer The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner who is continuing treatment with this medicine (of any strength) that was initiated by a medical practitioner as a PBS benefit.	Compliance with Authority Required procedures - Streamlined Authority Code 16698
C16699	P16699	CN16699	Tetrabenazine	Hyperkinetic extrapyramidal disorders The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.	Compliance with Authority Required procedures - Streamlined Authority Code 16699

[289] Schedule 5, entry for Abiraterone [GRP-29283]

insert in alphabetical order in the column headed “Brand”: Abiraterone Dr.Reddy’s

[290] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen [GRP-25060]

omit from the column headed “Brand”: Adalicip

[291] Schedule 5, entry for Allopurinol [GRP-15579]

insert in the column headed “Brand” after entry for the Brand “NOUMED ALLOPURINOL”: Progout Viatris

[292] Schedule 5, entry for Azacitidine

omit from the column headed “Brand”: Azacitidine-Teva

[293] Schedule 5, entries for Carbamazepine

omit from the column headed “Brand” (all instances): Carbamazepine Sandoz

[294] Schedule 5, entries for Ciclosporin

omit from the column headed “Brand” (all instances): Cyclosporin Sandoz

[295] Schedule 5, entry for Colchicine

insert in alphabetical order in the column headed “Brand”: COLCHICINE-WGR

[296] Schedule 5, entry for Dicloxacillin [GRP-22402]

omit from the column headed “Brand”: Dicloxacillin Mylan 250

[297] Schedule 5, after entry for Dicloxacillin in the form Capsule 250 mg (as sodium)

insert:

Dienogest

GRP-29716

Tablet 2 mg

Oral

Dinasane
Visanne

[298] Schedule 5, entry for Fluoxetine

insert in the column headed “Brand” after entry for the Brand “Fluoxetine Sandoz”: FLUOXETINE-WGR

[299] Schedule 5, entry for Fulvestrant

insert in alphabetical order in the column headed “Brand”: Fulvestrant SXP

[300] Schedule 5, entry for Furosemide [GRP-19673]

omit from the column headed “Brand”: NOUMED FUROSEMIDE

[301] Schedule 5, entry for Macrogol 3350

insert in the column headed “Brand” after entry for the Brand “APOHEALTH Macrogol with Electrolytes”: Chemists’ Own Constipation Relief with electrolytes

[302] Schedule 5, entry for Metformin [GRP-19608]

insert in alphabetical order in the column headed “Brand”: Blooms Metformin XR

[303] Schedule 5, entry for Metformin [GRP-24200]

insert in alphabetical order in the column headed “Brand”: Blooms Metformin XR

[304] Schedule 5, entry for Olanzapine [GRP-15513]

omit from the column headed “Brand”: Olanzapine APOTEX

[305] Schedule 5, entry for Ondansetron [GRP-15402]

omit from the column headed “Brand”: Ondansetron Mylan ODT

[306] Schedule 5, entry for Ondansetron [GRP-19791]

omit from the column headed “Brand”: Ondansetron Mylan Tablets

[307] Schedule 5, entry for Ondansetron [GRP-19626]

omit from the column headed “Brand”: Ondansetron Mylan Tablets

[308] Schedule 5, after entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 5 mg [GRP-22722]

insert:

Oxycodone with naloxone	GRP-29713	Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg	Oral	ARX-Oxycodone/Naloxone 40/20 Targin 40/20mg
Oxycodone with naloxone	GRP-29714	Tablet (controlled release) containing oxycodone hydrochloride 80 mg with naloxone hydrochloride 40 mg	Oral	ARX-Oxycodone/Naloxone 80/40 Targin 80/40
Oxycodone with naloxone	GRP-29715	Tablet (controlled release) containing oxycodone hydrochloride 15 mg with naloxone hydrochloride 7.5 mg	Oral	ARX-Oxycodone/Naloxone 15/7.5 Targin 15/7.5mg
Oxycodone with naloxone	GRP-29717	Tablet (controlled release) containing oxycodone hydrochloride 60 mg with naloxone hydrochloride 30 mg	Oral	ARX-Oxycodone/Naloxone 60/30 Targin 60/30
Oxycodone with naloxone	GRP-29718	Tablet (controlled release) containing oxycodone hydrochloride 5 mg with naloxone hydrochloride 2.5 mg	Oral	ARX-Oxycodone/Naloxone 5/2.5 Targin 5/2.5mg
Oxycodone with naloxone	GRP-29719	Tablet (controlled release) containing oxycodone hydrochloride 20 mg with naloxone hydrochloride 10 mg	Oral	ARX-Oxycodone/Naloxone 20/10 Targin 20/10mg
Oxycodone with naloxone	GRP-29720	Tablet (controlled release) containing oxycodone hydrochloride 2.5 mg with naloxone hydrochloride 1.25 mg	Oral	ARX-Oxycodone/Naloxone 2.5/1.25 Targin 2.5/1.25 mg
Oxycodone with naloxone	GRP-29723	Tablet (controlled release) containing oxycodone hydrochloride 10 mg with naloxone hydrochloride 5 mg	Oral	ARX-Oxycodone/Naloxone 10/5 Targin 10/5mg
Oxycodone with naloxone	GRP-29726	Tablet (controlled release) containing oxycodone hydrochloride 30 mg with naloxone hydrochloride 15 mg	Oral	ARX-Oxycodone/Naloxone 30/15 Targin 30/15 mg

[309] Schedule 5, entry for Paracetamol [GRP-20761]

insert in alphabetical order in the column headed “Brand”: Pharmacy Action Paracetamol Osteo 665

[310] Schedule 5, entry for Ramipril in the form Capsule 10 mg

omit from the column headed “Brand”: Ramipril Winthrop

[311] Schedule 5, after entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL

insert:

Ranitidine	GRP-19915	Tablet 300 mg (as hydrochloride)	Oral	APO-Ranitidine Zantac 300
Ranitidine	GRP-20724	Tablet 150 mg (as hydrochloride)	Oral	APO-Ranitidine Zantac 150

[312] Schedule 5, entry for Rosuvastatin [GRP-19558]

omit from the column headed “Brand”: Rosuvastatin APOTEX

[313] Schedule 5, entry for Valproic acid [GRP-19751]

omit from the column headed “Brand”: Valprease 200

[314] Schedule 5, entry for Valproic acid [GRP-19922]

omit from the column headed “Brand”: Valprease 500

Commencement Information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 June 2025	1 June 2025