Commonwealth Coat of Arms of Australia

 

PB 135 of 2024

 

National Health (Minimum Stockholding) Amendment Determination (No. 11) 2024

I, Eden Simon, as delegate of the Minister for Health and Aged Care, make the following determination.

Dated 28 November 2024

Eden Simon

Acting Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care

 

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments commencing 1 December 2024

National Health (Minimum Stockholding) Determination 2023

 

 

 

1  Name

 (1) This instrument is the National Health (Minimum Stockholding) Amendment Determination (No. 11) 2024.

 (2) This instrument may also be cited as PB 135 of 2024.

2  Commencement

  1.  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  Sections 1 to 4 and anything in this instrument not elsewhere covered by this table

1 December 2024.

1 December 2024

2.  Schedule 1

1 December 2024.

1 December 2024

 (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

  This instrument is made under subsection 99AEKC(2) of the National Health Act 1953.

4  Schedules

  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1Amendments commencing 1 December 2024

National Health (Minimum Stockholding) Determination 2023

1  Schedule 1 (table)

After:

Acarbose

Tablet 50 mg

Oral

GLYBOSAY

2 months stock by reference to usual demand

insert:

Aciclovir

Tablet 200 mg

Oral

Aciclovir APOTEX

4 months stock by reference to usual demand of both Aciclovir APOTEX and ARX-ACICLOVIR added together

Aciclovir

Tablet 200 mg

Oral

ARX-ACICLOVIR

4 months stock by reference to usual demand of both Aciclovir APOTEX and ARX-ACICLOVIR added together

Aciclovir

Tablet 800 mg

Oral

Aciclovir APOTEX

4 months stock by reference to usual demand of both Aciclovir APOTEX and ARX-ACICLOVIR added together

Aciclovir

Tablet 800 mg

Oral

ARX-ACICLOVIR

4 months stock by reference to usual demand of both Aciclovir APOTEX and ARX-ACICLOVIR added together

2  Schedule 1 (table)

After:

Allopurinol

Tablet 100 mg

Oral

Allosig

3 months stock by reference to usual demand

insert:

Allopurinol

Tablet 100 mg

Oral

APO-ALLOPURINOL

4 months stock by reference to usual demand of both Allopurinol APOTEX and APO-ALLOPURINOL added together

3  Schedule 1 (table)

After:

Allopurinol

Tablet 100 mg

Oral

Zyloprim

3 months stock by reference to usual demand

insert:

Allopurinol

Tablet 300 mg

Oral

APO-ALLOPURINOL

6 months stock by reference to usual demand of both Allopurinol APOTEX and APO-ALLOPURINOL added together

4  Schedule 1 (table)

After:

Amitriptyline

Tablet containing amitriptyline hydrochloride 50 mg

Oral

ENTRIP

(a) between 1 July 2023 and 31 December 2023—4 months stock by reference to usual demand

(b) after 31 December 2023—4.5 months stock by reference to usual demand

insert:

Amlodipine

Tablet 5 mg (as besilate)

Oral

APX-AMLODIPINE

6 months stock by reference to usual demand of both Amlodipine APOTEX and APX-AMLODIPINE added together

5  Schedule 1 (table)

After:

Atomoxetine

Capsule 80 mg (as hydrochloride)

Oral

APOAtomoxetine

3 months stock by reference to usual demand

insert:

Azacitidine

Powder for injection 100 mg

Injection

Azacitidine-Teva

between 1 December 2024 and 31 May 2025—0 months stock by reference to usual demand

6  Schedule 1 (table)

After:

Bisoprolol

Tablet containing bisoprolol fumarate 5 mg

Oral

Cipla Bisoprolol

between 1 July 2024 and 31 December 2024—0 months stock by reference to usual demand

insert:

Bivalirudin

Powder for I.V. injection 250 mg (as trifluoroacetate)

Injection

Bivalirudin APOTEX

4 months stock by reference to usual demand of both Bivalirudin APOTEX and BIVALIRUDIN ARX added together

Bivalirudin

Powder for I.V. injection 250 mg (as trifluoroacetate)

Injection

BIVALIRUDIN ARX

4 months stock by reference to usual demand of both Bivalirudin APOTEX and BIVALIRUDIN ARX added together

7  Schedule 1 (table)

After:

Carmellose with glycerin

Eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, 15 mL

Application to the Eye

Optive

between 1 October 2024 and 31 January 2025—0 months stock by reference to usual PBS demand

insert:

Cefazolin

Powder for injection 1 g (as sodium)

Injection

Cefazolin-AFT

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

8  Schedule 1 (table)

Omit:

Cefepime

Powder for injection 1 g (as hydrochloride)

Injection

Cefepime Kabi

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

Cefepime

Powder for injection 2 g (as hydrochloride)

Injection

Cefepime Kabi

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

9  Schedule 1 (table)

After:

Ciclosporin

Capsule 100 mg

Oral

APOCiclosporin

2.5 months stock by reference to usual demand

insert:

Ciclosporin

Capsule 100 mg

Oral

Cyclosporin Sandoz

between 1 December 2024 and 31 May 2025—0 months stock by reference to usual demand

10  Schedule 1 (table)

After:

Ciclosporin

Capsule 25 mg

Oral

APOCiclosporin

3 months stock by reference to usual demand

insert:

Ciclosporin

Capsule 25 mg

Oral

Cyclosporin Sandoz

between 1 December 2024 and 31 May 2025—0 months stock by reference to usual demand

11  Schedule 1 (table)

After:

Ciclosporin

Capsule 50 mg

Oral

APOCiclosporin

3 months stock by reference to usual demand

insert:

Ciclosporin

Capsule 50 mg

Oral

Cyclosporin Sandoz

between 1 December 2024 and 31 May 2025—0 months stock by reference to usual demand

12  Schedule 1 (table)

After:

Clonazepam

Oral liquid 2.5 mg per mL, 10 mL

Oral

Rivotril

6 months stock by reference to usual PBS demand

insert:

Clopidogrel with aspirin

Tablet 75 mg (as hydrogen sulfate)-100 mg

Oral

Clopidogrel Winthrop plus aspirin

between 1 December 2024 and 31 March 2025—0 months stock by reference to usual demand

13  Schedule 1 (table)

After:

Entecavir

Tablet 0.5 mg (as monohydrate)

Oral

Entecavir Viatris

after 30 September 2024—4 months stock by reference to usual demand of both Entecavir Viatris and Entecavir Mylan added together

insert:

Entecavir

Tablet 1 mg (as monohydrate)

Oral

Entecavir Viatris

after 28 February 2025— 4 months stock by reference to usual demand of both Entecavir Viatris and Entecavir Mylan added together

14  Schedule 1 (table)

Omit:

Epoprostenol

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

Epoprostenol

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

between 1 October 2024 and 30 November 2024—0 months stock by reference to usual demand

15  Schedule 1 (table)

After:

Fentanyl

Transdermal patch 8.4 mg

Transdermal

APOFentanyl

3 months stock by reference to usual demand

insert:

Fluconazole

Capsule 200 mg

Oral

APO-Fluconazole

4 months stock by reference to usual demand of both Fluconazole APOTEX and APO-Fluconazole added together

16  Schedule 1 (table)

Omit:

Furosemide

Oral solution 10 mg per ml, 30 ml

Oral

Lasix

(a) between 1 November 2024 and 31 March 2024—4 months stock by reference to usual PBS demand

(b) after 31 March 2024—6 months stock by reference to usual PBS demand

substitute:

Furosemide

Oral solution 10 mg per ml, 30 ml

Oral

Lasix

(a) between 1 November 2024 and 31 March 2025—4 months stock by reference to usual PBS demand

(b) after 31 March 2025—6 months stock by reference to usual PBS demand

17  Schedule 1 (table)

After:

Gabapentin

Capsule 400 mg

Oral

GAPENTIN

3 months stock by reference to usual demand

insert:

Gabapentin

Tablet 600 mg

Oral

APX-GABAPENTIN

4 months stock by reference to usual demand of both Gabapentin APOTEX and APX-GABAPENTIN added together

18  Schedule 1 (table)

After:

Galantamine

Capsule (prolonged release) 8 mg (as hydrobromide)

Oral

Gamine XR

3 months stock by reference to usual demand

insert:

Glimepiride

Tablet 1 mg

Oral

ARX-GLIMEPIRIDE

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 1 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 2 mg

Oral

ARX-GLIMEPIRIDE

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 2 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 3 mg

Oral

ARX-GLIMEPIRIDE

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 3 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 4 mg

Oral

ARX-GLIMEPIRIDE

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

Glimepiride

Tablet 4 mg

Oral

Glimepiride APOTEX

6 months stock by reference to usual demand of both Glimepiride APOTEX and ARX-GLIMEPRIDE added together

19  Schedule 1 (table)

Omit:

Imatinib

Capsule 100 mg (as mesilate)

Oral

ImatinibAPOTEX

3 months stock by reference to usual demand

Imatinib

Capsule 400 mg (as mesilate)

Oral

ImatinibAPOTEX

3 months stock by reference to usual demand

20  Schedule 1 (table)

After:

Hypromellose with carbomer 980

Ocular lubricating gel 3 mg-2 mg per g, 10 g

Application to the Eye

HPMC PAA

between 1 October 2024 and 30 June 2025—0 months stock by reference to usual demand

insert:

Imatinib

Capsule 100 mg (as mesilate)

Oral

ARX-IMATINIB

3 months stock by reference to usual demand of both Imatinib-APOTEX and ARX-IMATINIB added together

Imatinib

Capsule 100 mg (as mesilate)

Oral

Imatinib-APOTEX

3 months stock by reference to usual demand of both Imatinib-APOTEX and ARX-IMATINIB added together

Imatinib

Capsule 400 mg (as mesilate)

Oral

ARX-IMATINIB

3 months stock by reference to usual demand of both Imatinib-APOTEX and ARX-IMATINIB added together

Imatinib

Capsule 400 mg (as mesilate)

Oral

Imatinib-APOTEX

3 months stock by reference to usual demand of both Imatinib-APOTEX and ARX-IMATINIB added together

21  Schedule 1 (table)

After:

Irbesartan with hydrochlorothiazide

Tablet 150 mg-12.5 mg

Oral

AVSARTAN HCT 150/12.5

4 months stock by reference to usual demand

insert:

Iron polymaltose complex

Injection 100 mg (iron) in 2 mL

Injection

Ferrosig

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

22  Schedule 1 (table)

After:

Latanoprost with timolol

Eye drops 50 micrograms latanoprost with timolol 5 mg (as maleate) per mL, 2.5 mL

Application to the Eye

APOLatanoprost/Timolol 0.05/5

2.5 months stock by reference to usual demand

insert:

Leflunomide

Tablet 10 mg

Oral

APO-LEFLUNOMIDE

4 months stock by reference to usual demand of both Leflunomide APOTEX and APO-LEFLUNOMIDE added together

Leflunomide

Tablet 20 mg

Oral

APO-LEFLUNOMIDE

4 months stock by reference to usual demand of both Leflunomide APOTEX and APO-LEFLUNOMIDE added together

Lercanidipine

Tablet containing lercanidipine hydrochloride 10 mg

Oral

ARX-LERCANIDIPINE

6 months stock by reference to usual demand of both Lercanidipine APOTEX and ARX-LERCANIDIPINE added together

Lercanidipine

Tablet containing lercanidipine hydrochloride 20 mg

Oral

ARX-LERCANIDIPINE

6 months stock by reference to usual demand of both Lercanidipine APOTEX and ARX-LERCANIDIPINE added together

Letrozole

Tablet 2.5 mg

Oral

ARX-LETROZOLE

4 months stock by reference to usual demand of both Letrozole APOTEX and ARX-LETROZOLE added together

Letrozole

Tablet 2.5 mg

Oral

Letrozole APOTEX

4 months stock by reference to usual demand of both Letrozole APOTEX and ARX-LETROZOLE added together

23  Schedule 1 (table)

After:

Milk protein and fat formula with vitamins and minerals -- carbohydrate free

Oral powder 225 g (Carbohydrate Free Mixture)

Oral

Carbohydrate Free Mixture

6 months stock by reference to usual PBS demand

insert:

Mirtazapine

Tablet 45 mg

Oral

NOUMED MIRTAZAPINE

between 1 December 2024 and 31 January 2025—0 months stock by reference to usual demand

24 Schedule 1 (table)

After:

Modafinil

Tablet 100 mg

Oral

Modafin

3 months stock by reference to usual demand

insert:

Modafinil

Tablet 100 mg

Oral

Modafinil Viatris

after 28 February 2025— 4 months stock by reference to usual demand of both Modafinil Viatris and Modafinil Mylan added together

Montelukast

Tablet, chewable, 4 mg (as sodium)

Oral

APX-Montelukast

4 months stock by reference to usual demand of both Montelukast APOTEX and APX-Montelukast added together

Montelukast

Tablet, chewable, 5 mg (as sodium)

Oral

APX-Montelukast

4 months stock by reference to usual demand of both Montelukast APOTEX and APX-Montelukast added together

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

ARX-MYCOPHENOLATE

4 months stock by reference to usual demand of both Mycophenolate APOTEX and ARX-MYCOPHENOLATE added together

Mycophenolic acid

Tablet containing mycophenolate mofetil 500 mg

Oral

Mycophenolate APOTEX

4 months stock by reference to usual demand of both Mycophenolate APOTEX and ARX-MYCOPHENOLATE added together

25  Schedule 1 (table)

After:

Nortriptyline

Tablet 25 mg (as hydrochloride)

Oral

NortriTABS 25 mg

between 1 October 2024 and 31 December 2024—0 months stock by reference to usual demand

insert:

Olanzapine

Tablet 10 mg

Oral

APO-OLANZAPINE

4 months stock by reference to usual demand of both Olanzapine APOTEX and APO-OLANZAPINE added together

26  Schedule 1 (table)

After:

Olanzapine

Tablet 15 mg (orally disintegrating)

Oral

Zypine ODT

(a) between 1 February 2024 and 30 September 2024—4 months stock by reference to usual demand of the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 15 mg, Oral;

(b) between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand of both the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 15 mg, Oral and the brand Zypine ODT of the pharmaceutical item Olanzapine, Tablet 15 mg (orally disintegrating), Oral, added together.

insert:

Olanzapine

Tablet 2.5 mg

Oral

APO-OLANZAPINE

6 months stock by reference to usual demand of both Olanzapine APOTEX and APO-OLANZAPINE added together

27  Schedule 1 (table)

After:

Olanzapine

Tablet 20 mg (orally disintegrating)

Oral

Zypine ODT

(a) between 1 February 2024 and 30 September 2024—4 months stock by reference to usual demand of the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 20 mg, Oral;

(b) between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand of both the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 20 mg, Oral and the brand Zypine ODT of the pharmaceutical item Olanzapine, Tablet 20 mg (orally disintegrating), Oral, added together

insert:

Olanzapine

Tablet 5 mg

Oral

APO-OLANZAPINE

4 months stock by reference to usual demand of both Olanzapine APOTEX and APO-OLANZAPINE added together

28  Schedule 1 (table)

After:

Olanzapine

Tablet 5 mg (orally disintegrating)

Oral

Zypine ODT

(a) between 1 February 2024 and 30 September 2024—4 months stock by reference to usual demand of the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 5 mg, Oral;

(b) between 1 October 2024 and 31 March 2025—4 months stock by reference to usual demand of both the brand Zypine ODT of the pharmaceutical item Olanzapine, Wafer 5 mg, Oral and the brand Zypine ODT of the pharmaceutical item Olanzapine, Tablet 5 mg (orally disintegrating), Oral, added together

insert:

Olanzapine

Tablet 7.5 mg

Oral

APO-OLANZAPINE

4 months stock by reference to usual demand of both Olanzapine APOTEX and APO-OLANZAPINE added together

29  Schedule 1 (table)

After:

Olmesartan

Tablet containing olmesartan medoxomil 40 mg

Oral

OLMERTAN

(a) between 1 July 2023 and 31 December 2023—3 months stock by reference to usual demand

(b) after 31 December 2023—3.5 months stock by reference to usual demand

insert:

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besilate)

Oral

APO-OLMESARTAN/AMLODIPINE 20/5

4 months stock by reference to usual demand of both Olmesartan/Amlodipine 20/5 APOTEX and APO-OLMESARTAN/AMLODIPINE 20/5 mg added together

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besilate)

Oral

APO-OLMESARTAN/AMLODIPINE 40/10

4 months stock by reference to usual demand of both Olmesartan/Amlodipine 40/10 APOTEX and APO-OLMESARTAN/AMLODIPINE 40/10 added together

Olmesartan with amlodipine

Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besilate)

Oral

APO-OLMESARTAN/AMLODIPINE 40/5

4 months stock by reference to usual demand of both Olmesartan/Amlodipine 40/5 APOTEX and APO-OLMESARTAN/AMLODIPINE 40/5 mg added together

30  Schedule 1 (table)

After:

Pantoprazole

Sachet containing granules 40 mg (as sodium sesquihydrate)

Oral

Somac

4 months stock by reference to usual PBS demand

insert:

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APX-PANTOPRAZOLE

6 months stock by reference to usual demand of both Pantoprazole APOTEX and APX-PANTOPRAZOLE added together

31  Schedule 1 (table)

After:

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

APOPantoprazole

(a) between 1 July 2023 and 31 December 2023—4.5 months stock by reference to usual demand

(b) after 31 December 2023—5.5 months stock by reference to usual demand

insert:

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

APX-PANTOPRAZOLE

6 months stock by reference to usual demand of both Pantoprazole APOTEX and APX-PANTOPRAZOLE added together

32  Schedule 1 (table)

After:

Permethrin

Cream 50 mg per g, 30 g

Application

Lyclear

6 months stock by reference to usual PBS demand

insert:

Phenoxymethylpenicillin

Powder for oral liquid 125 mg (as potassium) per 5 mL, 100 mL

Oral

Phenoxymethylpenicillin-AFT

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

33  Schedule 1 (table)

After:

Pimecrolimus

Cream 10 mg per g, 15 g

Application

Elidel

6 months stock by reference to usual PBS demand

insert:

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

Pioglitazone

Tablet 15 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

Pioglitazone

Tablet 30 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

APOTEX-Pioglitazone

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

Pioglitazone

Tablet 45 mg (as hydrochloride)

Oral

ARX-PIOGLITAZONE

4 months stock by reference to usual demand of both APOTEX-Pioglitazone and ARX-PIOGLITAZONE added together

34  Schedule 1 (table)

After:

Protein hydrolysate formula with medium chain triglycerides

Oral powder 450 g (Aptamil Gold+ Pepti-Junior)

Oral

Aptamil Gold+ Pepti-Junior

6 months stock by reference to usual PBS demand

insert:

Quetiapine

Tablet 100 mg (as fumarate)

Oral

APX-QUETIAPINE

4 months stock by reference to usual demand of both Quetiapine APOTEX and APX-QUETIAPINE added together

Quetiapine

Tablet 200 mg (as fumarate)

Oral

APX-QUETIAPINE

4 months stock by reference to usual demand of both Quetiapine APOTEX and APX-QUETIAPINE added together

Quetiapine

Tablet 25 mg (as fumarate)

Oral

APX-QUETIAPINE

4 months stock by reference to usual demand of both Quetiapine APOTEX and APX-QUETIAPINE added together

Quetiapine

Tablet 300 mg (as fumarate)

Oral

APX-QUETIAPINE

4 months stock by reference to usual demand of both Quetiapine APOTEX and APX-QUETIAPINE added together

35  Schedule 1 (table)

After:

Risperidone

Tablet 3 mg

Oral

Rispa

3 months stock by reference to usual demand

insert:

Rizatriptan

Tablet (orally disintegrating) 10 mg (as benzoate)

Oral

APO-RIZATRIPTAN ODT

4 months stock by reference to usual demand of both Rizatriptan ODT APOTEX and APO-RIZATRIPTAN ODT added together

Rosuvastatin

Tablet 10 mg (as calcium)

Oral

APO-Rosuvastatin

6 months stock by reference to usual demand of both Rosuvastatin APOTEX and APO-Rosuvastatin added together

Rosuvastatin

Tablet 20 mg (as calcium)

Oral

APO-ROSUVASTATIN

4 months stock by reference to usual demand of both Rosuvastatin APOTEX and APO-ROSUVASTATIN added together

Rosuvastatin

Tablet 40 mg (as calcium)

Oral

APO-ROSUVASTATIN

4 months stock by reference to usual demand of both Rosuvastatin APOTEX and APO-ROSUVASTATIN added together

Rosuvastatin

Tablet 5 mg (as calcium)

Oral

APO-ROSUVASTATIN

6 months stock by reference to usual demand of both Rosuvastatin APOTEX and APO-ROSUVASTATIN added together

36  Schedule 1 (table)

Omit:

Salbutamol

Nebuliser solution 2.5 mg (as sulfate) in 2.5 ml single dose units, 30

Inhalation

Salbutamol Cipla

between 1 June 2024 and 30 November 2024—4 months stock by reference to usual demand.

Salbutamol

Nebuliser solution 5 mg (as sulfate) in 2.5 ml single dose units, 30

Inhalation

Salbutamol Cipla

between 1 June 2024 and 30 November 2024—4 months stock by reference to usual demand.

37  Schedule 1 (table)

After:

Sertraline

Tablet 50 mg (as hydrochloride)

Oral

NOUMED SERTRALINE

between 1 November 2024 and 31 December 2024—0 months stock by reference to usual demand

insert:

Sevelamer

Tablet containing sevelamer carbonate 800 mg

Oral

ARX-SEVELAMER

4 months stock by reference to usual demand of both Sevelamer Apotex and ARX-SEVELAMER added together

Sevelamer

Tablet containing sevelamer carbonate 800 mg

Oral

Sevelamer Apotex

4 months stock by reference to usual demand of both Sevelamer Apotex and ARX-SEVELAMER added together

38  Schedule 1 (table)

After:

Tacrolimus

Capsule 5 mg

Oral

Tacrograf

3 months stock by reference to usual demand

insert:

Telmisartan

Tablet 40 mg

Oral

NOUMED TELMISARTAN

between 1 December 2024 and 31 January 2025—0 months stock by reference to usual demand

39  Schedule 1 (table)

After:

Temazepam

Tablet 10 mg

Oral

APOTemazepam

2.5 months stock by reference to usual demand

insert:

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir APOTEX

4 months stock by reference to usual demand of both Tenofovir APOTEX and Tenofovir ARX added together

Tenofovir

Tablet containing tenofovir disoproxil fumarate 300 mg

Oral

Tenofovir ARX

4 months stock by reference to usual demand of both Tenofovir APOTEX and Tenofovir ARX added together

40  Schedule 1 (table)

Omit:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine 300/200 APOTEX

3 months stock by reference to usual demand

41  Schedule 1 (table)

After:

Tenofovir

Tablet containing tenofovir disoproxil maleate 300 mg

Oral

Tenofovir Disoproxil Viatris

after 31 January 2025— 4 months stock by reference to usual demand of both Tenofovir Disoproxil Viatris and Tenofovir Disoproxil Mylan added together

insert:

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

Tenofovir/Emtricitabine 300/200 APOTEX

3 months stock by reference to usual demand of both Tenofovir/Emtricitabine 300/200 APOTEX and TENOFOVIR/EMTRICITABINE 300/200 ARX added together

Tenofovir with emtricitabine

Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg

Oral

TENOFOVIR/EMTRICITABINE 300/200 ARX

3 months stock by reference to usual demand of both Tenofovir/Emtricitabine 300/200 APOTEX and TENOFOVIR/EMTRICITABINE 300/200 ARX added together

42  Schedule 1 (table)

After:

Valproic acid

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

Oral

Epilim Syrup

6 months stock by reference to usual PBS demand

insert:

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

APO-Sodium Valproate

between 1 April 2025 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Epilim EC

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Sodium Valproate Sandoz

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valprease 200

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valpro EC 200

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 200 mg

Oral

Valproate Winthrop EC 200

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

APO-Sodium Valproate

between 1 April 2025 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Epilim EC

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Sodium Valproate Sandoz

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valprease 500

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valpro EC 500

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

Valproic acid

Tablet (enteric coated) containing sodium valproate 500 mg

Oral

Valproate Winthrop EC 500

between 1 December 2024 and 31 May 2025—4 months stock by reference to usual demand

43  Schedule 1 (table)

Omit:

Vancomycin

Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

Injection

Vancomycin Viatris

after 31 November 2024— 4 months stock by reference to usual demand of both Vancomycin Viatris and Vancomycin Alphapharm added together

substitute:

Vancomycin

Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

Injection

Vancomycin Viatris

4 months stock by reference to usual demand of both Vancomycin Viatris and Vancomycin Alphapharm added together

44  Schedule 1 (table)

Omit:

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Vancomycin Viatris

after 31 November 2024— 4 months stock by reference to usual demand of both Vancomycin Viatris and Vancomycin Alphapharm added together

substitute:

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Vancomycin Viatris

4 months stock by reference to usual demand of both Vancomycin Viatris and Vancomycin Alphapharm added together