National Health Act 1953 Amendment determination under section 84AF Responsible persons (No. PB 16 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 16 of 2008

Amendment determination under section 84AF 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 section 84AF of the National Health Act 1953.

Dated 2^nd January 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 February 2008.

2              Amendment of PB 90 of 2007

Schedule 1 amends PB 90 of 2007.

Schedule 1        Amendments

[1]            Schedule 1, items dealing with Amisulpride in the forms
Tablet 100 mg, Tablet 200 mg and Tablet 400 mg

omit from the columns in the order indicated:

Amisulpride Sandoz sanofi-aventis Australia Pty Ltd 31 008 558 807

and substitute:

Amisulpride Sandoz Sandoz Pty Ltd 60 075 449 553

[2]            Schedule 1, items dealing with Cephalexin in the form Capsule 250 mg (anhydrous)

omit from the column headed “Brand”:

Cephalexin-Lupin

and substitute:

Cephalexin Max

[3]            Schedule 1, items dealing with Cephalexin in the form Capsule 500 mg (anhydrous)

omit from the column headed “Brand”:

Cephalexin-Lupin

and substitute:

Cephalexin Max

[4]            Schedule 1, items dealing with Codeine with Paracetamol in the form
Tablet containing codeine phosphate 30 mg with paracetamol 500 mg

omit from the columns in the order indicated:

Comfarol Forte sanofi-aventis Australia Pty Ltd 31 008 558 807

and substitute:

Comfarol Forte Sandoz Pty Ltd 60 075 449 553

[5]            Schedule 1, items dealing with Diltiazem in the forms
Capsule (controlled delivery) containing diltiazem hydrochloride
180 mg, Capsule (controlled delivery) containing diltiazem hydrochloride 240 mg and Capsule (controlled delivery) containing diltiazem hydrochloride 360 mg

omit from the columns in the order indicated:

Diltahexal CD sanofi-aventis Australia Pty Ltd 31 008 558 807

and substitute:

Diltahexal CD Sandoz Pty Ltd 60 075 449 553

[6]           Schedule 1, after item dealing with Fosinopril in the form Tablet containing fosinopril sodium 10 mg (Fosinopril Sandoz)

insert in the columns in the order indicated:

Fosinopril Tablet containing fosinopril sodium 10 mg Oral Fosinopril Winthrop Sandoz Pty Ltd 60 075 449 553

[7]           Schedule 1, after item dealing with Fosinopril in the form Tablet containing fosinopril sodium 20 mg (Fosinopril Sandoz)

insert in the columns in the order indicated:

Fosinopril Tablet containing fosinopril sodium 20 mg Oral Fosinopril Winthrop Sandoz Pty Ltd 60 075 449 553

[8]           Schedule 1, after item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Sandoz 10 mg/12.5 mg)

insert in the columns in the order indicated:

Fosinopril with Hydrochlorothiazide Tablet containing fosinopril sodium 10 mg with hydrochlorothazide 12.5 mg Oral Fosinopril/HCT Winthrop
10 mg/12.5 mg Sandoz Pty Ltd 60 075 449 553

[9]           Schedule 1, after item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Sandoz 20 mg/12.5 mg)

insert in the columns in the order indicated:

Fosinopril with Hydrochlorothiazide Tablet containing fosinopril sodium 20 mg with hydrochlorothazide 12.5 mg Oral Fosinopril/HCT Winthrop
20 mg/12.5 mg Sandoz Pty Ltd 60 075 449 553

[10]         Schedule 1, after item dealing with Gabapentin in the form Tablet
600 mg (Gabaran)

insert in the columns in the order indicated:

Gabapentin Tablet 600 mg Oral GenRx Gabapentin Apotex Pty Ltd 52 096 916 148

[11]         Schedule 1, after item dealing with Gabapentin in the form Tablet
800 mg (Gantin)

insert in the columns in the order indicated:

Gabapentin Tablet 800 mg Oral GenRx Gabapentin Apotex Pty Ltd 52 096 916 148

[12]          Schedule 1, items dealing with Influenza Vaccine

omit all five items and substitute the following four items in the columns in the order indicated:

Influenza Vaccine	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	Injection	Vaxigrip Junior	Sanofi Pasteur Pty Ltd	79 085 258 797
Influenza Vaccine	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	Injection	Fluvax	CSL Biotherapies Pty Ltd	66 120 398 067
Influenza Vaccine	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	Injection	Influvac	Solvay Biosciences Pty Ltd	41 007 401 201
Influenza Vaccine	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	Injection	Vaxigrip	Sanofi Pasteur Pty Ltd	79 085 258 797

[13]          Schedule 1, items dealing with Isotretinoin

omit from the columns in the order indicated:

Isotretinoin Capsule 20 mg Oral Isohexal Sandoz Pty Ltd 60 075 449 553

[14]          Schedule 1, items dealing with Metoprolol

omit from the columns in the order indicated:

Metoprolol	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	Toprol-XL Titration Pack	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol	Tablet containing metoprolol succinate 190 mg (controlled release)	Oral	Toprol-XL 190	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol	Tablet containing metoprolol succinate 23.75 mg (controlled release)	Oral	Toprol-XL 23.75	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol	Tablet containing metoprolol succinate 47.5 mg (controlled release)	Oral	Toprol-XL 47.5	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol	Tablet containing metoprolol succinate 95 mg (controlled release)	Oral	Toprol-XL 95	AstraZeneca Pty Ltd	54 009 682 311

[15]          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	Toprol-XL Titration Pack	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol succinate	Tablet 190 mg (controlled release)	Oral	Toprol-XL 190	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol succinate	Tablet 23.75 mg (controlled release)	Oral	Toprol-XL 23.75	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol succinate	Tablet 47.5 mg (controlled release)	Oral	Toprol-XL 47.5	AstraZeneca Pty Ltd	54 009 682 311
Metoprolol succinate	Tablet 95 mg (controlled release)	Oral	Toprol-XL 95	AstraZeneca Pty Ltd	54 009 682 311

[16]          Schedule 1, after item dealing with Omeprazole in the form Tablet
10 mg (as magnesium)

insert in the columns in the order indicated:

Omeprazole Tablet 20 mg Oral GenRx Omeprazole Apotex Pty Ltd 52 096 916 148

[17]          Schedule 1, after item dealing with Oxybutynin in the form Tablet containing oxybutynin hydrochloride 5 mg (Oxybutynin Sandoz)

insert in the columns in the order indicated:

Oxybutynin Tablet containing oxybutynin hydrochloride 5 mg Oral Oxybutynin Winthrop sanofi-aventis Australia Pty Ltd 31 008 558 807

[18]          Schedule 1, after item dealing with Quinapril in the form Tablet 10 mg (Acquin 10)

insert in the columns in the order indicated:

Quinapril Tablet 10 mg (as hydrochloride) Oral APO-Quinapril Apotex Pty Ltd 52 096 916 148

[19]          Schedule 1, after item dealing with Quinapril in the form Tablet 10 mg (Filpril)

insert in the columns in the order indicated:

Quinapril	Tablet 10 mg (as hydrochloride)	Oral	Pharmacor Quinapril 10	Pharmacor Pty Limited	58 121 020 835
Quinapril	Tablet 10 mg (as hydrochloride)	Oral	Quinapril-DP	Genepharm (Australia) Limited	17 003 854 626

[20]          Schedule 1, after item dealing with Quinapril in the form Tablet 20 mg (Acquin 20)

insert in the columns in the order indicated:

Quinapril Tablet 20 mg (as hydrochloride) Oral APO-Quinapril Apotex Pty Ltd 52 096 916 148

[21]          Schedule 1, after item dealing with Quinapril in the form Tablet 20 mg (Filpril)

insert in the columns in the order indicated:

Quinapril	Tablet 20 mg (as hydrochloride)	Oral	Pharmacor Quinapril 20	Pharmacor Pty Limited	58 121 020 835
Quinapril	Tablet 20 mg (as hydrochloride)	Oral	Quinapril-DP	Genepharm (Australia) Limited	17 003 854 626

[22]          Schedule 1, after item dealing with Quinapril in the form Tablet 5 mg (Acquin 5)

insert in the columns in the order indicated:

Quinapril Tablet 5 mg (as hydrochloride) Oral APO-Quinapril Apotex Pty Ltd 52 096 916 148

[23]          Schedule 1, after item dealing with Quinapril in the form Tablet 5 mg (Filpril)

insert in the columns in the order indicated:

Quinapril	Tablet 5 mg (as hydrochloride)	Oral	Pharmacor Quinapril 5	Pharmacor Pty Limited	58 121 020 835
Quinapril	Tablet 5 mg (as hydrochloride)	Oral	Quinapril-DP	Genepharm (Australia) Limited	17 003 854 626

[24]          Schedule 1, after item dealing with Sumatriptan in the form
Tablet 50 mg (as succinate) (Imigran)

insert in the columns in the order indicated:

Sumitriptan Tablet 50 mg (as succinate) Oral Sumagran 50 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[25]          Schedule 1, items dealing with Trimethoprim with Sulfamethoxazole

omit from the columns in the order indicated:

Trimethoprim with Sulfamethoxazole Tablet 80 mg-400 mg Oral Septrin Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

[26]          Schedule 1, items dealing with Valproic Acid in the forms
Tablet (enteric coated) containing sodium valproate 200 mg and Tablet (enteric coated) containing sodium valproate 500 mg

omit from the columns in the order indicated:

Sodium Valproate Sandoz sanofi-aventis Australia Pty Ltd 31 008 558 807

and substitute:

Sodium Valproate Sandoz Sandoz Pty Ltd 60 075 449 553