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

Schedule 1—Amendments

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

[1] Schedule 1, Part 1, entry for Acarbose in the form Tablet 100 mg

omit:

Acarbose Mylan

MP NP

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

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

AMANTAMED

MP NP

C5132

100

(b) insert in the column headed “Schedule Equivalent” for the brand “Symmetrel 100”: a

[3] Schedule 1, Part 1, entry for Ambrisentan in the form Tablet 10 mg

omit:

Ambrisentan Mylan

See Note 3

D(100)

[4] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without methionine

omit:

Sachets containing oral powder 24 g, 30 (HCU gel)

Oral

HCU gel

MP NP

C5534

[5] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

omit:

Sachets containing oral powder 24 g, 30 (TYR gel)

Oral

TYR gel

MP NP

C5533

[6] Schedule 1, Part 1, entry for Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

omit:

Sachets containing oral powder 24 g, 30 (MSUD gel)

Oral

MSUD gel

MP NP

C5571

[7] Schedule 1, Part 1, entry for Amisulpride in the form Tablet 100 mg

omit:

Amisulpride 100 Winthrop

MP NP

C4246

[8] Schedule 1, Part 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besilate); and Tablet 10 mg (as besilate)

(a) omit:

Amlodipine Amneal

MP NP

(b) omit:

Amlodipine Amneal

MP NP

P14238

[9] Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

substitute:

Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	a	AlphaClav Duo	AF	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	AMCLAVOX DUO 500/125	RW	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	Amoxycillin/Clavulanic Acid 500/125 APOTEX	TY	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	APO-AMOXY/CLAV 500/125	TW	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	APO-Amoxycillin/ Clavulanic Acid 500/125	TX	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	APX-Amoxicillin/Clavulanic Acid	XT	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	Augmentin Duo	AS	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	Curam Duo 500/125	SZ	MP NP	C5832 C5893 C10405	P5832 P5893	10	10
					MW	C5832 C5893		10	10
					PDP	C5833 C5894		10	10
		a	AlphaClav Duo	AF	MP NP	C5832 C5893 C10405	P10405	20	10
		a	AMCLAVOX DUO 500/125	RW	MP NP	C5832 C5893 C10405	P10405	20	10
		a	Amoxycillin/Clavulanic Acid 500/125 APOTEX	TY	MP NP	C5832 C5893 C10405	P10405	20	10
		a	APO-AMOXY/CLAV 500/125	TW	MP NP	C5832 C5893 C10405	P10405	20	10
		a	APO-Amoxycillin/ Clavulanic Acid 500/125	TX	MP NP	C5832 C5893 C10405	P10405	20	10
		a	APX-Amoxicillin/Clavulanic Acid	XT	MP NP	C5832 C5893 C10405	P10405	20	10
		a	Augmentin Duo	AS	MP NP	C5832 C5893 C10405	P10405	20	10
		a	Curam Duo 500/125	SZ	MP NP	C5832 C5893 C10405	P10405	20	10

[10] Schedule 1, Part 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

(a) omit:

				Amoxyclav AN 875/125	EA	MP NP	C5832 C5893 C10413	P5832 P5893	10	0	10
						PDP	C5833 C5894		10	0	10

(b) omit:

Amoxyclav AN 875/125

MP NP

C5832 C5893 C10413

P10413

[11] Schedule 1, Part 1, entry for Aripiprazole in each of the forms: Tablet 10 mg; Tablet 15 mg; and Tablet 20 mg

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

ARIZOLE

MP NP

C4246

[12] Schedule 1, Part 1, entry for Aripiprazole in the form Tablet 30 mg

(a) omit:

Aripiprazole generichealth

MP NP

C4246

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

ARIZOLE

MP NP

C4246

[13] Schedule 1, Part 1, entry for Atenolol in the form Tablet 50 mg

(a) omit:

Atenolol Amneal

MP NP

(b) omit:

Atenolol Amneal

MP NP

P14238

[14] Schedule 1, Part 1, entry for Azathioprine in the form Tablet 50 mg

omit:

Azathioprine GH

MP NP

100

[15] Schedule 1, Part 1, entry for Bleomycin

omit:

CIPLA BLEOMYCIN

C6224 C6275

See Note 3

D(100)

[16] Schedule 1, Part 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)

omit:

Bosentan Cipla

See Note 3

D(100)

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

(a) omit:

Calcitriol AN

MP NP

C5089 C5114 C5255 C5401 C5402 C14231 C14259 C14287 C14296 C14322

P5089 P5114 P5255 P5401 P5402

100

(b) omit:

Calcitriol AN

MP NP

C5089 C5114 C5255 C5401 C5402 C14231 C14259 C14287 C14296 C14322

P14231 P14259 P14287 P14296 P14322

200

100

[18] Schedule 1, Part 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g (as hydrochloride)

omit:

Cefepime Alphapharm

MP NP

C5842

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

(a) omit:

Cinacalcet Mylan

MP NP

C10068

(b) omit:

Cinacalcet Mylan

C10063 C10067 C10073

C(100)

[20] Schedule 1, Part 1, entry for Citalopram in the form Tablet 10 mg (as hydrobromide)

omit:

Citalopram AN

MP NP

C4755

[21] Schedule 1, Part 1, entry for Citalopram in each of the forms: Tablet 20 mg (as hydrobromide); and Tablet 40 mg (as hydrobromide)

omit:

Citalopram AN

MP NP

C4755

[22] Schedule 1, Part 1, entry for Clarithromycin in the form Tablet 250 mg

omit:

Clarithromycin AN

MP NP

[23] Schedule 1, Part 1, entry for Colestyramine

insert as first entry:

	Sachet containing 4 g oral powder (s19A)	Oral		Cholestyramine-Odan	DZ	MP NP			100	5	30
						MP		P6429	100	11	30

[24] Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 50 mg

(a) omit:

Cyprone 50

P5532

20
CN5532

5
CN5532

(b) omit:

Cyprone 50

100

[25] Schedule 1, Part 1, entry for Cyproterone in the form Tablet containing cyproterone acetate 100 mg

omit:

Cyprone 100

[26] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 90 mg

(a) omit:

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

D(100)

(b) omit:

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

D(100)

[27] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 180 mg

(a) omit:

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

D(100)

(b) omit:

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

D(100)

[28] Schedule 1, Part 1, entry for Deferasirox in the form Tablet 360 mg

(a) omit:

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7385 P8326 P8328 P8329 P9222 P9258 P9302

180

D(100)

(b) omit:

CIPLA DEFERASIROX

C7374 C7375 C7385 C8326 C8328 C8329 C9222 C9258 C9302

P7374 P7375

180

D(100)

[29] Schedule 1, Part 1, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg

omit:

Desvenlafaxine Actavis

MP NP

C5650

[30] Schedule 1, Part 1, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg

omit:

Desvenlafaxine Actavis

MP NP

C5650

[31] Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 25 mg

(a) omit:

Diclofenac AN

PDP

100

(b) omit:

Diclofenac AN

MP NP

100

[32] Schedule 1, Part 1, entry for Diclofenac in the form Tablet (enteric coated) containing diclofenac sodium 50 mg

(a) omit:

Diclofenac AN

PDP

(b) omit:

Diclofenac AN

MP NP

[33] Schedule 1, Part 1, entry for Diltiazem in the form Tablet containing diltiazem hydrochloride 60 mg

omit:

Diltiazem AN

MP NP

[34] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-10 mg

(a) omit:

EZEVYT 10/10

MP NP

C7958 C14269

P7958

(b) omit:

EZEVYT 10/10

MP NP

C7958 C14269

P14269

[35] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-20 mg

(a) omit:

EZEVYT 10/20

MP NP

C7958 C14269

P7958

(b) omit:

EZEVYT 10/20

MP NP

C7958 C14269

P14269

[36] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-40 mg

(a) omit:

EZEVYT 10/40

MP NP

C7957 C14284

P7957

(b) omit:

EZEVYT 10/40

MP NP

C7957 C14284

P14284

[37] Schedule 1, Part 1, entry for Ezetimibe with simvastatin in the form Tablet 10 mg-80 mg

(a) omit:

EZEVYT 10/80

MP NP

C7957 C14284

P7957

(b) omit:

EZEVYT 10/80

MP NP

C7957 C14284

P14284

[38] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 125 mg

omit:

Famciclovir-GA

MP NP

C5937

[39] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 250 mg

(a) omit:

Famciclovir-GA

MP NP

C5937 C5951

P5937

(b) omit:

Famciclovir-GA

MP NP

C5937 C5951

P5951

[40] Schedule 1, Part 1, entry for Famciclovir in the form Tablet 500 mg

omit:

Famciclovir-GA

MP NP

C5947 C5948 C5949 C5954

[41] Schedule 1, Part 1, entry for Fluoxetine

insert as first entry:

Capsule 10 mg (Medreich) (S19A)

Oral

Fluoxetine Capsules 10 mg (Medreich, UK)

MP NP

C14828 C14832

[42] Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

omit:

Seroflo 125/25

MP NP

C4930

[43] Schedule 1, Part 1, entry for Fluticasone propionate with salmeterol in the form Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation)

omit:

Seroflo 250/25

MP NP

C4930 C10121

[44] Schedule 1, Part 1, entry for Furosemide in each of the forms: Tablet 20 mg; and Tablet 40 mg

(a) omit:

FUROSEMIDE AN

MP NP

100

(b) omit:

FUROSEMIDE AN

MP NP

P14238

200

100

[45] Schedule 1, Part 1, entry for Gabapentin in the form Tablet 600 mg

omit:

Gabapentin AN

MP NP

C4928

100

[46] Schedule 1, Part 1, entry for Gliclazide in the form Tablet 30 mg (modified release)

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

Gliclazide MR Viatris

MP NP

100

[47] Schedule 1, Part 1, entry for Glimepiride in the form Tablet 2 mg

omit:

Amaryl

MP NP

[48] Schedule 1, Part 1, entry for Ipilimumab in each of the forms: Injection concentrate for I.V. infusion 50 mg in 10 mL; and Injection concentrate for I.V. infusion 200 mg in 40 mL

(a) omit from the column headed “Circumstances”: C13841

(b) insert in numerical order in the column headed “Circumstances”: C14808

[49] Schedule 1, Part 1, entry for Irbesartan in the form Tablet 75 mg

(a) omit:

			a	Irbesartan AMNEAL	EF	MP NP			30	5	30
			a	Irbesartan AN	EA	MP NP			30	5	30

(b) omit:

Irbesartan AMNEAL

MP NP

P14238

Irbesartan AN

MP NP

P14238

[50] Schedule 1, Part 1, entry for Irbesartan in the form Tablet 300 mg

(a) omit:

Irbesartan AN

MP NP

(b) omit:

Irbesartan AN

MP NP

P14238

[51] Schedule 1, Part 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL; and I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL

omit:

MEDITAB IRINOTECAN

See Note 3

D(100)

[52] Schedule 1, Part 1, entry for Isosorbide mononitrate in the form Tablet 60 mg (sustained release)

(a) omit:

			a	Isosorbide AN	EA	MP NP			30	5	30
			a	Monodur 60 mg	IY	MP NP			30	5	30

(b) omit:

Isosorbide AN

MP NP

P14238

Monodur 60 mg

MP NP

P14238

[53] Schedule 1, Part 1, entry for Isotretinoin in the form Capsule 10 mg

omit:

Rocta 10

C5224

[54] Schedule 1, Part 1, entry for Isotretinoin in the form Capsule 20 mg

omit:

Rocta 20

C5224

[55] Schedule 1, Part 1, entry for Meloxicam in each of the forms: Capsule 7.5 mg; and Capsule 15 mg

(a) omit:

Chem mart Meloxicam

MP NP

C4907 C4962

(b) omit:

Terry White Chemists Meloxicam

MP NP

C4907 C4962

[56] Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit:

Metformin AN

MP NP

100

[57] Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 850 mg

(a) omit:

Chem mart Metformin

MP NP

(b) omit:

Metformin AN

MP NP

Terry White Chemists Metformin

MP NP

[58] Schedule 1, Part 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g

omit:

Metformin AN

MP NP

[59] Schedule 1, Part 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial

omit:

Pfizer Australia Pty Ltd

See Note 3

PB(100)

P6276

See Note 3

PB(100)

[60] Schedule 1, Part 1, entry for Methylprednisolone in the form Cream containing methylprednisolone aceponate 1 mg per g, 15 g

omit from the column headed “Responsible Person” for the brand “Supriad Cream” (all instances): LG substitute (all instances): XT

[61] Schedule 1, Part 1, entry for Methylprednisolone in the form Fatty ointment containing methylprednisolone aceponate 1 mg per g, 15 g

omit from the column headed “Responsible Person” for the brand “Supriad Fatty Ointment” (all instances): LG substitute (all instances): XT

[62] Schedule 1, Part 1, entry for Methylprednisolone in the form Ointment containing methylprednisolone aceponate 1 mg per g, 15 g

omit from the column headed “Responsible Person” for the brand “Supriad Ointment” (all instances): LG substitute (all instances): XT

[63] Schedule 1, Part 1, entry for Metoclopramide in the form Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

substitute:

Metoclopramide

Injection containing 10 mg metoclopramide hydrochloride (as monohydrate) in 2 mL

Injection

METOCLOPRAMIDE INJECTION BP

MP NP MW PDP

MP NP

P6084

40
CN6084

2
CN6084

[64] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 15 mg (orally disintegrating)

(a) omit from the column headed “Schedule Equivalent” for the brand “MIRTANZA ODT”: a

(b) omit:

Mirtazapine AN ODT

MP NP

C5650

[65] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg

omit:

Mirtazon

MP NP

C5650

[66] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 30 mg (orally disintegrating)

(a) omit from the column headed “Schedule Equivalent” for the brand “MIRTANZA ODT”: a

(b) omit:

Mirtazapine AN ODT

MP NP

C5650

[67] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg

omit:

Mirtazon

MP NP

C5650

[68] Schedule 1, Part 1, entry for Mirtazapine in the form Tablet 45 mg (orally disintegrating)

(a) omit from the column headed “Schedule Equivalent” for the brand “MIRTANZA ODT”: a

(b) omit:

Mirtazapine AN ODT

MP NP

C5650

[69] Schedule 1, Part 1, entry for Moclobemide in each of the forms: Tablet 150 mg; and Tablet 300 mg

omit:

Moclobemide AN

MP NP

C5650

[70] Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid

substitute:

Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid

Oral

Mycophenolic Acid ARX

120

Myfortic

120

Mycophenolic Acid ARX

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

C(100)

Myfortic

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

C(100)

[71] Schedule 1, Part 1, entry for Mycophenolic acid in the form Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

substitute:

Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid

Oral

Mycophenolic Acid ARX

120

MYCOTEX

120

Myfortic

120

Mycophenolic Acid ARX

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

C(100)

MYCOTEX

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

C(100)

Myfortic

P4084 P4095 P9692 P9809

240
CN4084 CN4095 CN9692 CN9809

5
CN4084 CN4095 CN9692 CN9809

120

C(100)

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

insert as the first entry:

Injection 150 mg in 1 mL single dose pre-filled syringe

Injection

Tysabri

C13625 C13718

D(100)

[73] Schedule 1, Part 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride) [Maximum Quantity: 56; Number of Repeats: 5]

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

Nebivolol Viatris

MP NP

C5324 C14251

P5324

[74] Schedule 1, Part 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride) [Maximum Quantity: 112; Number of Repeats: 5]

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

Nebivolol Viatris

MP NP

C5324 C14251

P14251

112

[75] Schedule 1, Part 1, entry for Nebivolol in the form Tablet 10 mg (as hydrochloride) [Maximum Quantity: 28; Number of Repeats: 5]

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

Nebivolol Viatris

MP NP

C5324 C14251

P5324

[76] Schedule 1, Part 1, entry for Nebivolol in the form Tablet 10 mg (as hydrochloride) [Maximum Quantity: 56; Number of Repeats: 5]

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

Nebivolol Viatris

MP NP

C5324 C14251

P14251

[77] Schedule 1, Part 1, entry for Nitrofurantoin in each of the forms: Capsule 50 mg; and Capsule 100 mg

omit:

APO-Nitrofurantoin

MP NP MW

[78] Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a) omit from the column headed “Circumstances”: C10155

(b) omit from the column headed “Circumstances”: C13853

[79] Schedule 1, Part 1, after entry for Nivolumab in the form Injection concentrate for I.V. infusion 100 mg in 10 mL

insert:

Nivolumab with relatlimab

Solution concentrate for I.V. infusion containing 240 mg nivolumab and 80 mg relatlimab in 20 mL

Injection

Opdualag

C14812 C14815 C14819 C14829

P14812 P14819

D(100)

C14812 C14815 C14819 C14829

P14815 P14829

D(100)

[80] Schedule 1, Part 1, entry for Octreotide in the form Injection 100 micrograms (as acetate) in 1 mL

substitute:

Injection 100 micrograms (as acetate) in 1 mL

Injection

Octreotide (SUN)

C6369 C6390 C8165 C9232 C9233 C9289

D(100)

Octreotide GH

C6369 C6390 C8165 C9232 C9233 C9289

D(100)

Sandostatin 0.1

C6369 C6390 C8165 C9232 C9233 C9289

D(100)

[81] Schedule 1, Part 1, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

(a) omit:

				Ondansetron AN ODT	EA	MP NP	C5618 C10498	P5618	4	0	4
						MP	C5743		4	0	4		C(100)

(b) omit:

Ondansetron AN ODT

MP NP

C5618 C10498

P10498

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

(a) omit:

			a	Ondansetron AN	EA	MP NP	C4118 C10498	P4118	4	0	4
						MP	C5778		4	0	4		C(100)

(b) omit:

Ondansetron AN

MP NP

C4118 C10498

P10498

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

(a) omit:

				Ondansetron AN ODT	EA	MP NP	C5618 C10498	P5618	4	0	4
						MP	C5743		4	0	4		C(100)

(b) omit:

Ondansetron AN ODT

MP NP

C5618 C10498

P10498

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

(a) omit:

			a	Ondansetron AN	EA	MP NP	C4118 C10498	P4118	4	0	4
						MP	C5778		4	0	4		C(100)

(b) omit:

Ondansetron AN

MP NP

C4118 C10498

P10498

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

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

			a	PALONOSETRON Medsurge	DZ	MP NP	C5686		1	0	1
						MP	C5805		1	0	1		C(100)

[86] Schedule 1, Part 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

(a) omit:

			a	Pantoprazole AN	EA	MP	C8774 C8775 C8776 C8780 C8866 C11310	P8774 P8775	30	1	30
						NP	C8774 C8775 C8776 C8780 C8866	P8774 P8775	30	1	30

(b) omit:

			a	Pantoprazole AN	EA	MP	C8774 C8775 C8776 C8780 C8866 C11310	P8776 P8780 P8866	30	5	30
						NP	C8774 C8775 C8776 C8780 C8866	P8776 P8780 P8866	30	5	30

Pantoprazole AN

C8774 C8775 C8776 C8780 C8866 C11310

P11310

[87] Schedule 1, Part 1, entry for Paroxetine

omit:

Paroxetine AN

MP NP

C4755 C6277 C6636

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

omit:

Ristempa

C7822 C7843 C9235 C9303

D(100)

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

(a) omit from the column headed “Circumstances”: C10689 C10696

(b) insert in numerical order in the column headed “Circumstances”: C14817 C14818

[90] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg

(a) omit:

Perindopril generichealth

MP NP

(b) omit:

Perindopril generichealth

MP NP

P14238

[91] Schedule 1, Part 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg

(a) omit:

Perindopril generichealth

MP NP

(b) omit:

Perindopril generichealth

MP NP

P14238

[92] Schedule 1, Part 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)

omit:

Quetiapine AN

MP NP

C4246 C5611 C5639

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

omit:

Quetiapine AN

MP NP

C4246 C5611 C5639

[94] Schedule 1, Part 1, entry for Ramipril in the form Capsule 1.25 mg

substitute:

Ramipril	Capsule 1.25 mg	Oral		Tryzan Caps 1.25	AF	MP NP			30	5	30
						MP NP		P14238	60	5	30

[95] Schedule 1, Part 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

omit:

Rizatriptan AN ODT

MP NP

C5708

[96] Schedule 1, Part 1, after entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20

insert:

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 (S19A)

Inhalation

pms-SALBUTAMOL

MP NP

C6815 C6825

[97] Schedule 1, Part 1, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30

omit:

Salbutamol AN

MP NP

C6815 C6825

[98] Schedule 1, Part 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)

omit:

Sertraline AN

MP NP

C4755 C6277 C6289

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

omit:

Sildenafil AN PHT 20

See Note 3

D(100)

[100] Schedule 1, Part 1, after entry for Tapentadol in the form Tablet (modified release) 250 mg (as hydrochloride)

insert:

Tebentafusp

Solution concentrate for I.V. infusion 100 micrograms in 0.5 mL

Injection

Kimmtrak

C14813 C14821 C14822 C14825

See Note 3

D(100)

[101] Schedule 1, Part 1, entry for Tenofovir in the form Tablet containing tenofovir disoproxil maleate 300 mg

substitute:

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Mylan

MP NP

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P10362

D(100)

Tenofovir Disoproxil Viatris

MP NP

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P10362

D(100)

Tenofovir Disoproxil Mylan

MP NP

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P6980 P6982 P6983 P6984 P6992 P6998

D(100)

Tenofovir Disoproxil Viatris

MP NP

C6980 C6982 C6983 C6984 C6992 C6998 C10362

P6980 P6982 P6983 P6984 P6992 P6998

D(100)

[102] Schedule 1, Part 1, entry for Tenofovir with emtricitabine and efavirenz

(a) omit:

Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600

MP NP

C4470 C4522

D(100)

(b) omit from the column headed “Schedule Equivalent” for the brand “Tenofovir Disoproxil Emtricitabine Efavirenz Viatris 300/200/600”: a

[103] Schedule 1, Part 1, entry for Terbinafine in the form Cream containing terbinafine hydrochloride 10 mg per g, 15 g

omit from the column headed “Responsible Person”: GJ substitute: NP

[104] Schedule 1, Part 1, entry for Tobramycin in the form Injection 80 mg in 2 mL

(a) omit:

Tobramycin Mylan

MP NP

C5446 C5490 C5519

(b) omit from the column headed “Schedule Equivalent” for the brand “Tobramycin Viatris”: a

[105] Schedule 1, Part 1, entry for Trientine

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

Trientine Dr. Reddy's

MP NP

C13321

200

100

(b) insert in the column headed “Schedule Equivalent” for the brand “Trientine Waymade”: a

[106] Schedule 1, Part 1, entry for Varenicline in the form Box containing 11 tablets 0.5 mg (as tartrate) and 14 tablets 1 mg (as tartrate) in the first pack and 28 tablets 1 mg (as tartrate) in the second pack

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

VARENAPIX

MP NP

C6871

[107] Schedule 1, Part 2, omit entry for Amino acid formula with vitamins and minerals without phenylalanine

[108] Schedule 1, Part 2, omit entry for Efavirenz

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

[110] Schedule 1, Part 2, omit entry for Ertugliflozin

[111] Schedule 1, Part 2, omit entry for Ertugliflozin with sitagliptin

[112] Schedule 3

omit:

Apotex Pty Ltd

52 096 916 148

[113] Schedule 3

omit:

Amneal Pharmaceuticals Pty Ltd

11 163 167 851

[114] Schedule 3

omit:

Leo Pharma Pty Ltd

72 147 880 617

[115] Schedule 3, after details relevant to Responsible Person code NO

insert:

Nice-Pak Products Pty. Ltd

71 051 956 346

[116] Schedule 3, after details relevant to Responsible Person code WA

insert:

MEDISON PHARMA AUSTRALIA PTY LIMITED

19 659 723 403

[117] Schedule 4, Part 1, omit entry for Efavirenz

[118] Schedule 4, Part 1, omit entry for Ertugliflozin

[119] Schedule 4, Part 1, omit entry for Ertugliflozin with sitagliptin

[120] Schedule 4, Part 1, entry for Fluoxetine

insert in numerical order after existing text:

	C14828			Obsessive-compulsive disorder Patient must be receiving this drug under this restriction at a dose of 10 mg; OR Patient must be receiving this drug under this restriction where a 10 mg strength is required to administer the total dose.
	C14832			Major depressive disorders Patient must be receiving this drug under this restriction at a dose of 10 mg; OR Patient must be receiving this drug under this restriction where a 10 mg strength is required to administer the total dose.

[121] Schedule 4, Part 1, entry for Ipilimumab

(a) omit:

C13841

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 13841

(b) insert in numerical order after existing text:

C14808

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 14808

[122] Schedule 4, Part 1, entry for Nivolumab

(a) omit:

C10155

Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures - Streamlined Authority Code 10155

(b) omit:

C13853

Unresectable Stage III or Stage IV malignant melanoma
Induction treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be ocular or uveal melanoma; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.

Compliance with Authority Required procedures - Streamlined Authority Code 13853

	C14816			Unresectable Stage III or Stage IV malignant melanoma Initial treatment Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 14816
	C14830			Unresectable Stage III or Stage IV malignant melanoma Induction treatment Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be ocular or uveal melanoma; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks. Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.	Compliance with Authority Required procedures - Streamlined Authority Code 14830

[123] Schedule 4, Part 1, after entry for Nivolumab

insert:

Nivolumab with relatlimab	C14812	P14812	Unresectable Stage III or Stage IV malignant melanoma Initial treatment Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be uveal melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must weigh 40 kg or more; AND Patient must be at least 12 years of age. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 14812
	C14815	P14815	Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 14815
	C14819	P14819	Unresectable Stage III or Stage IV malignant melanoma Initial treatment Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be uveal melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must weigh 40 kg or more; AND Patient must be at least 12 years of age. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 14819
	C14829	P14829	Unresectable Stage III or Stage IV malignant melanoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 14829

[124] Schedule 4, Part 1, entry for Pembrolizumab

(a) omit:

	C10689			Unresectable Stage III or Stage IV malignant melanoma Initial treatment - 6 weekly treatment regimen Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 3 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 10689
	C10696			Unresectable Stage III or Stage IV malignant melanoma Initial treatment - 3 weekly treatment regimen Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 10696

(b) insert in numerical order after existing text:

	C14817			Unresectable Stage III or Stage IV malignant melanoma Initial treatment - 6 weekly treatment regimen Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 3 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 14817
	C14818			Unresectable Stage III or Stage IV malignant melanoma Initial treatment - 3 weekly treatment regimen Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 14818

[125] Schedule 4, Part 1, after entry for Tapentadol

insert:

Tebentafusp	C14813	Advanced (unresectable or metastatic) uveal melanoma Initial treatment - day 1 Patient must have HLA-A02:01-positive disease; AND Patient must have uveal melanoma that has been confirmed either (i) histologically, (ii) cytologically; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior systemic therapy for metastatic disease. Patient must be at least 18 years of age. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Positive HLA-A02:01 assessment must be documented in the patient's medical records.	Compliance with Authority Required procedures
	C14821	Advanced (unresectable or metastatic) uveal melanoma Initial treatment - day 8 Patient must have HLA-A02:01-positive disease; AND Patient must have previously received PBS-subsidised initial day 1 treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Positive HLA-A02:01 assessment must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 14821
	C14822	Advanced (unresectable or metastatic) uveal melanoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not receive PBS-subsidised treatment with this drug for this condition if it is no longer determined to be clinically beneficial by the treating clinician. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.	Compliance with Authority Required procedures - Streamlined Authority Code 14822
	C14825	Advanced (unresectable or metastatic) uveal melanoma Initial treatment - day 15 Patient must have HLA-A02:01-positive disease; AND Patient must have previously received PBS-subsidised initial day 8 treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Positive HLA-A02:01 assessment must be documented in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 14825

[126] Schedule 5, entry for Amoxicillin with clavulanic acid

substitute:

Amoxicillin with clavulanic acid	GRP-26768	Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)	Oral	AMCLAVOX DUO FORTE 875/125 APO-AMOXY/CLAV 875/125 APO-Amoxycillin and Clavulanic Acid APX-Amoxicillin/Clavulanic Acid AlphaClav Duo Forte Alphaclav Duo Forte Viatris AmoxyClav generichealth 875/125 Augmentin Duo forte Blooms The Chemist Amoxicillin/Clavulanic Acid 875/125 Curam Duo Forte 875/125
		Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (s19A)	Oral	Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo - Medsurge) Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Aurobindo – Pro Pharmaceuticals) Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg (Micro Labs)

[127] Schedule 5, entry for Desvenlafaxine in the form Tablet (modified release) 100 mg [GRP-16219]

omit from the column headed “Brand”: Desvenlafaxine Actavis

[128] Schedule 5, entry for Desvenlafaxine in the form Tablet (modified release) 50 mg [GRP-16220]

omit from the column headed “Brand”: Desvenlafaxine Actavis

[129] Schedule 5, entry for Meloxicam in the form Capsule 15 mg [GRP-15468]

(a) omit from the column headed “Brand”: Chem mart Meloxicam

(b) omit from the column headed “Brand”: Terry White Chemists Meloxicam

[130] Schedule 5, entry for Meloxicam in the form Capsule 7.5 mg [GRP-15658]

(a) omit from the column headed “Brand”: Chem mart Meloxicam

(b) omit from the column headed “Brand”: Terry White Chemists Meloxicam

[131] Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg [GRP-15402]

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

[132] Schedule 5, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg [GRP-15983]

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

[133] Schedule 5, entry for Perindopril, Schedule Equivalent Group GRP-15442

substitute:

Perindopril	GRP-15442	Tablet containing perindopril erbumine 4 mg	Oral	APO-Perindopril BTC Perindopril Blooms the Chemist Perindopril Idaprex 4 Indosyl Mono 4 PERISYL Perindo
		Tablet containing perindopril arginine 5 mg	Oral	APO-Perindopril Arginine APX-Perindopril Arginine Coversyl 5mg PREXUM 5

[134] Schedule 5, entry for Perindopril, Schedule Equivalent Group GRP-15525

substitute:

	GRP-15525	Tablet containing perindopril erbumine 8 mg	Oral	APO-Perindopril BTC Perindopril Blooms the Chemist Perindopril Idaprex 8 Indosyl Mono 8 PERISYL Perindo
		Tablet containing perindopril arginine 10 mg	Oral	APO-Perindopril Arginine APX-Perindopril Arginine Coversyl 10mg PREXUM 10

[135] Schedule 5, entry for Ramipril in the form Capsule 1.25 mg [GRP-15640]

omit from the column headed “Brand”: APO-Ramipril

[136] Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)

omit from the column headed “Brand”: Rizatriptan AN ODT

[137] Schedule 5, entry for Salbutamol in the form Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 [GRP-21361]

omit from the column headed “Brand”: Salbutamol AN

[138] Schedule 5, after entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 [GRP-21535]

insert:

Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 20 (S19A)

Inhalation

pms-SALBUTAMOL

[139] Schedule 5, entry for Tenofovir in the form Tablet containing tenofovir disoproxil maleate 300 mg

insert in alphabetical order in the column headed “Brand”: Tenofovir Disoproxil Viatris

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 February 2024	1 February 2024