National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 10 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 10 of 2009

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

I, ADRIANA PLATONA, 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 30 January 2009

ADRIANA PLATONA

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 March 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

1. Schedule 1, after items dealing with Amlodipine with Atorvastatin

insert in the columns in the order indicated:

Amlodipine with valsartan	Tablet 10 mg (as besylate)-160 mg	Oral	Exforge 10/160	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Amlodipine with valsartan	Tablet 5 mg (as besylate)-160 mg	Oral	Exforge 5/160	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Amlodipine with valsartan	Tablet 5 mg (as besylate)-80 mg	Oral	Exforge 5/80	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160

1. Schedule 1, after item dealing with Amoxycillin in the form Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL (Amoxil Forte)

insert in the columns in the order indicated:

Amoxycillin Powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL Oral Amoxycillin Sandoz Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, items dealing with Amoxycillin with Clavulanic Acid

(a) omit from the columns in the order indicated:

Amoxycillin with Clavulanic Acid Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL Oral Clamohexal 125mg/31.25mg/5mL Sandoz Pty Ltd 60 075 449 553

(b) omit from the columns in the order indicated:

Amoxycillin with Clavulanic Acid Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with
57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL Oral Clamohexal Duo 400mg/57mg/5mL Sandoz Pty Ltd 60 075 449 553

(c) omit from the columns in the order indicated:

Amoxycillin with Clavulanic Acid Tablet containing
500 mg amoxycillin (as trihydrate) with
125 mg clavulanic acid (as potassium clavulanate) Oral Clamohexal Duo 500mg/125mg Sandoz Pty Ltd 60 075 449 553

(d) omit from the columns in the order indicated:

Amoxycillin with Clavulanic Acid Tablet containing
875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Oral Clamohexal Duo Forte 875mg/125mg Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, after items dealing with Ampicillin

insert in the columns in the order indicated:

Amylopectin, modified long chain Sachets containing oral powder 60 g, 30 (Glycosade) Oral Glycosade Vitaflo Australia Pty Limited 82 097 161 254

1. Schedule 1, items dealing with Baclofen

(a) omit from the columns in the order indicated:

Baclofen Tablet 10 mg Oral Baclohexal Sandoz Pty Ltd 60 075 449 553

(b) omit from the columns in the order indicated:

Baclofen Tablet 25 mg Oral Baclohexal Sandoz Pty Ltd 60 075 449 553

1. Schedule 1, after item dealing with Cefaclor in the form Tablet (sustained release) 375 mg (as monohydrate) (Ceclor CD)

insert in the columns in the order indicated:

Cefaclor Tablet (sustained release) 375 mg (as monohydrate) Oral Cefaclor-GA Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, item dealing with Chlorthalidone

omit from the columns in the order indicated:

Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

1. Schedule 1, after item dealing with Diclofenac in the form Tablet
   (enteric coated) containing diclofenac sodium 25 mg (Clonac 25)

insert in the columns in the order indicated:

Diclofenac Tablet (enteric coated) containing diclofenac sodium 25 mg Oral Diclofenac-GA Ascent Pharmahealth Ltd 52 107 340 367

1. Schedule 1, after item dealing with Essential amino acids formula with minerals and vitamin C in the form Oral powder 400 g

insert in the columns in the order indicated:

Essential amino acids formula with vitamins and minerals Sachets containing oral powder 12.5 g, 50 (EAA Supplement) Oral EAA Supplement Vitaflo Australia Pty Limited 82 097 161 254

1. Schedule 1, items dealing with Irinotecan

omit from the columns in the order indicated:

Irinotecan I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in
5 mL Injection Irinotecan-GA Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, item dealing with Methysergide

omit from the columns in the order indicated:

Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

1. Schedule 1, items dealing with Pancrelipase

omit from the columns in the order indicated:

Pancrelipase Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity Oral Cotazym-S Forte Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, after items dealing with Phenoxymethylpenicillin

insert in the columns in the order indicated:

Phenylalanine with carbohydrate Sachets of oral powder 4 g containing 50 mg phenylalanine, 30 (Phenylalanine Amino Acid Supplement) Oral Phenylalanine Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254

1. Schedule 1, items dealing with Salbutamol

omit from the columns in the order indicated:

Salbutamol Pressurised inhalation 100 micrograms (as sulfate) per dose, 200 doses (CFC-free formulation) Inhalation by mouth Epaq Arrow Pharmaceuticals Pty Ltd 17 003 144 170

1. Schedule 1, after item dealing with Telmisartan with Hydrochlorothiazide in the form Tablet 80 mg-12.5 mg

insert in the columns in the order indicated:

Telmisartan with Hydrochlorothiazide Tablet 80 mg-25 mg Oral Micardis Plus 80/25 mg Boehringer Ingelheim Pty Ltd 52 000 452 308

1. Schedule 1, after items dealing with Trandolapril

insert in the columns in the order indicated:

Trandolapril with Verapamil Tablet containing trandolapril 2 mg with verapamil hydrochloride 180 mg (sustained release) Oral Tarka 2/180 Abbott Australasia Pty Ltd 95 000 180 389

1. Schedule 1, after item dealing with Triglycerides — medium chain, formula in the form Oral powder 420 g (Caprilon)

insert in the columns in the order indicated:

Triglycerides ─ medium chain, formula Sachets containing oral powder 16 g, 25 (MCT Pro-Cal) Oral MCT Pro-Cal Vitaflo Australia Pty Limited 82 097 161 254

1. Schedule 1, after item dealing with Valproic Acid in the form Tablet, crushable, containing sodium valproate 100 mg

insert in the columns in the order indicated:

Valsartan	Tablet 160 mg	Oral	Diovan	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan	Tablet 320 mg	Oral	Diovan	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan	Tablet 40 mg	Oral	Diovan	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan	Tablet 80 mg	Oral	Diovan	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan with hydrochlorothiazide	Tablet 160 mg-12.5 mg	Oral	Co-Diovan 160/12.5	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan with hydrochlorothiazide	Tablet 160 mg-25 mg	Oral	Co-Diovan 160/25	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Valsartan with hydrochlorothiazide	Tablet 80 mg-12.5 mg	Oral	Co-Diovan 80/12.5	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160

1. Schedule 1, after item dealing with Vinorelbine in the form Solution for I.V. infusion 10 mg (as tartrate) in 1 mL (Navelbine)

insert in the columns in the order indicated:

Vinorelbine Solution for I.V. infusion 10 mg (as tartrate) in 1 mL Injection Vinorelbine 10 Link Link Medical Products Pty Ltd 73 010 971 516

1. Schedule 1, after item dealing with Vinorelbine in the form Solution for I.V. infusion 50 mg (as tartrate) in 5 mL (Navelbine)

insert in the columns in the order indicated:

Vinorelbine Solution for I.V. infusion 50 mg (as tartrate) in 5 mL Injection Vinorelbine 50 Link Link Medical Products Pty Ltd 73 010 971 516

1. Schedule 1, after items dealing with Warfarin

insert in the columns in the order indicated:

Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose Sachets containing oral powder 100 g, 10 (RenaStart) Oral RenaStart Vitaflo Australia Pty Limited 82 097 161 254