National Health Act 1953 Amendment determinations under sections 85, 85A and 88 Pharmaceutical Benefits (No. PB 15 of 2008) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 15 of 2008

Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953

I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.

Dated 2nd January 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination — pharmaceutical benefits

1              Commencement

This instrument commences on 1 February 2008.

2              Amendment of PB 89 of 2007

Schedule 1 amends PB 89 of 2007.

Schedule 1        Amendments

[1]           Part 1 of Schedule 1, item dealing with Cephalexin in the form Capsule 250 mg (anhydrous)

omit from the column headed “Brand”:

Cephalexin-Lupin

and substitute:

Cephalexin Max

[2]           Part 1 of Schedule 1, item dealing with Cephalexin in the form Capsule 500 mg (anhydrous)

omit from the column headed “Brand”:

Cephalexin-Lupin

and substitute:

Cephalexin Max

[3]           Part 1 of Schedule 1, item dealing with Cetuximab in the form Solution for I.V. infusion 100 mg in 50 mL

omit from the column headed “Maximum quantity”:

6

and substitute:

1

[4]           Part 1 of Schedule 1, item dealing with Fosinopril in the form Tablet containing fosinopril sodium 10 mg

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

Fosinopril Winthrop

  1. Part 1 of Schedule 1, item dealing with Fosinopril in the form Tablet containing fosinopril sodium 20 mg

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

Fosinopril Winthrop

  1. Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg

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

Fosinopril/HCT Winthrop 10 mg/12.5 mg

  1. Part 1 of Schedule 1, item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg

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

Fosinopril/HCT Winthrop 20 mg/12.5 mg

[8]           Part 1 of Schedule 1, item dealing with Gabapentin in the form Tablet 600 mg

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

GenRx Gabapentin

  1. Part 1 of Schedule 1, item dealing with Gabapentin in the form Tablet 800 mg

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

GenRx Gabapentin

[10]         Part 1 of Schedule 1, items dealing with Influenza Vaccine

(a)   item dealing with ‘Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe’, omit from the column headed “Brand”:

Fluarix

(b)   omit from the column headed “Form (strength, type, size, etc.)”:

Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe

and substitute:

Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Brisbane/10/2007 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Florida/4/2006-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe

(c)       omit from the column headed “Form (strength, type, size, etc.)”:

Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe

and substitute:

Injection containing inactivated, split virion influenza vaccine, 0.5 mL of which contains antigens representative of the following types: A/Solomon Islands/3/2006 (H1N1)-like strain 15 micrograms haemagglutinin; A/Brisbane/10/2007 (H3N2)-like strain 15 micrograms haemagglutinin; B/Florida/4/2006-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe

[11]        Part 1 of Schedule 1, item dealing with Isotretinoin in the form Capsule 20 mg

omit from the column headed “Brand”:

Isohexal

[12]         Part 1 of Schedule 1, items dealing with Metoprolol

omit from the columns in the order indicated:

Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol succinate 95 mg (controlled release) Oral 1 .. Toprol-XL Titration Pack
Tablet containing metoprolol succinate 23.75 mg (controlled release) Oral 15 .. Toprol-XL 23.75
Tablet containing metoprolol succinate 47.5 mg (controlled release) Oral 30 5 Toprol-XL 47.5
Tablet containing metoprolol succinate 95 mg (controlled release) Oral 30 5 Toprol-XL 95
Tablet containing metoprolol succinate 190 mg (controlled release) Oral 30 5 Toprol-XL 190
  1. Part 1 of Schedule 1, after items dealing with Metoprolol

insert in the columns in the order indicated:

Metoprolol succinate Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release) Oral 1 .. Toprol-XL Titration Pack
Tablet 23.75 mg (controlled release) Oral 15 .. Toprol-XL 23.75
Tablet 47.5 mg (controlled release) Oral 30 5 Toprol-XL 47.5
Tablet 95 mg (controlled release) Oral 30 5 Toprol-XL 95
Tablet 190 mg (controlled release) Oral 30 5 Toprol-XL 190

[14]         Part 1 of Schedule 1, item dealing with Omeprazole in the form Tablet 20 mg

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

GenRx Omeprazole

[15]         Part 1 of Schedule 1, item dealing with Oxybutynin in the form Tablet containing oxybutynin hydrochloride 5 mg

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

Oxybutynin Winthrop

[16]         Part 1 of Schedule 1, item dealing with Quinapril in the form Tablet 5 mg (as hydrochloride)

(a)   in the column headed “Brand” insert in alphabetical order:

APO-Quinapril

(b)   in the column headed “Brand” insert in alphabetical order:

Pharmacor Quinapril 5

(c)   in the column headed “Brand” insert in alphabetical order:

Quinapril-DP

[17]         Part 1 of Schedule 1, item dealing with Quinapril in the form Tablet 10 mg (as hydrochloride)

(a)   in the column headed “Brand” insert in alphabetical order:

APO-Quinapril

(b)   in the column headed “Brand” insert in alphabetical order:

Pharmacor Quinapril 10

(c)   in the column headed “Brand” insert in alphabetical order:

Quinapril-DP

  1. Part 1 of Schedule 1, item dealing with Quinapril in the form Tablet 20 mg (as hydrochloride)

(a)   in the column headed “Brand” insert in alphabetical order:

APO-Quinapril

(b)   in the column headed “Brand” insert in alphabetical order:

Pharmacor Quinapril 20

(c)   in the column headed “Brand” insert in alphabetical order:

Quinapril-DP

  1. Part 1 of Schedule 1, item dealing with Sumatriptan in the form Tablet 50 mg (as succinate)

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

Sumagran 50

[20]         Part 1 of Schedule 1, item dealing with Trimethoprim with Sulfamethoxazole in the form Tablet 80 mg-400 mg

omit from the column headed “Brand”:

Septrin

[21]         Part 2 of Schedule 1, item dealing with Cetuximab in the form Solution for I.V. infusion 100 mg in 50 mL

omit from the column headed “Maximum quantity”:

4

and substitute:

1

[22]         Part 2 of Schedule 1, item dealing with Omeprazole in the form Tablet 20 mg

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

GenRx Omeprazole

[23]         Part 2 of Schedule 1, item dealing with Pemetrexed

omit from the column headed “Purposes” the words:

Pleural mesothelioma

and substitute:

Mesothelioma

  1. Part 1 of Schedule 3, item dealing with Cephalexin in the form Capsule 250 mg (anhydrous)

omit from the column headed “Brand”:

Cephalexin-Lupin

and substitute:

Cephalexin Max

[25]         Part 1 of Schedule 3, item dealing with Cephalexin in the form Capsule 500 mg (anhydrous)

omit from the column headed “Brand”:

Cephalexin-Lupin

and substitute:

Cephalexin Max

  1. Part 1 of Schedule 3, item dealing with Trimethoprim with Sulfamethoxazole in the form Tablet 80 mg-400 mg

omit from the column headed “Brand”:

Septrin

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