National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 3 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 3 of 2009

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 2nd JANUARY 2009

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 2009.

2              Amendment of PB 115 of 2008

Schedule 1 amends PB 115 of 2008.

Schedule 1        Amendments

1. Schedule 1, item dealing with Adrenaline in the form I.M. injection
   150 micrograms in 0.3 mL single dose syringe auto-injector

omit from the columns in the order indicated:

CSL Biotherapies Pty Ltd 66 120 398 067

and substitute:

Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, item dealing with Adrenaline in the form I.M. injection
   300 micrograms in 0.3 mL single dose syringe auto-injector

omit from the columns in the order indicated:

CSL Biotherapies Pty Ltd 66 120 398 067

and substitute:

Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, after item dealing with Alendronic Acid in the form Tablet 70 mg (as alendronate sodium) (Alendronate Sandoz)

insert in  the columns in the order indicated:

Alendronic Acid Tablet 70 mg (as alendronate sodium) Oral Alendronate-GA Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, items dealing with Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

omit from the columns in the order indicated:

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 325 g (Ketonex-2)	Oral	Ketonex-2	Abbott Australasia Pty Ltd	95 000 180 389
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 350 g (Ketonex-1)	Oral	Ketonex-1	Abbott Australasia Pty Ltd	95 000 180 389

1. Schedule 1, items dealing with Amlodipine in the form Tablet 10 mg
   (as besylate)

omit from the columns in the order indicated:

Amlodipine Tablet 10 mg (as besylate) Oral Amlotrust 10 Meditech Int. Pty Ltd 17 069 879 465

1. Schedule 1, after item dealing with Amlodipine in the form Tablet
   10 mg (as besylate) (Perivasc)

insert in the columns in the order indicated:

Amlodipine Tablet 10 mg (as besylate) Oral Pharmacor Amlodipine 10 Pharmacor Pty Limited 58 121 020 835

1. Schedule 1, items dealing with Amlodipine in the form Tablet 5 mg
   (as besylate)

omit from the columns in the order indicated:

Amlodipine Tablet 5 mg (as besylate) Oral Amlotrust 5 Meditech Int. Pty Ltd 17 069 879 465

1. Schedule 1, after item dealing with Amlodipine in the form Tablet
   5 mg (as besylate) (Perivasc)

insert in the columns in the order indicated:

Amlodipine Tablet 5 mg (as besylate) Oral Pharmacor Amlodipine 5 Pharmacor Pty Limited 58 121 020 835

1. Schedule 1, items dealing with Atenolol in the form Tablet 50 mg

omit from the columns in the order indicated:

Atenolol Tablet 50 mg Oral Anselol 50 mg Genepharm Pty Ltd 68 118 734 795

1. Schedule 1, item dealing with “BCG-Tice” (Bacillus Calmette-Guérin/Tice strain) in the form Vial containing powder for intravesical administration approximately 5 x 10⁸ CFU (OncoTICE)

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, after item dealing with Carvedilol in the form Tablet
   12.5 mg (Terry White Chemists Carvedilol 12.5 mg)

insert in the columns in the order indicated:

Carvedilol Tablet 12.5 mg Oral Vedilol 12.5 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

1. Schedule 1, after item dealing with Carvedilol in the form Tablet
   25 mg (Terry White Chemists Carvedilol 25 mg)

insert in the columns in the order indicated:

Carvedilol Tablet 25 mg Oral Vedilol 25 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

1. Schedule 1, after item dealing with Carvedilol in the form Tablet
   3.125 mg (Terry White Chemists Carvedilol 3.125 mg)

insert in the columns in the order indicated:

Carvedilol Tablet 3.125 mg Oral Vedilol 3.125 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

1. Schedule 1, after item dealing with Carvedilol in the form Tablet
   6.25 mg (Terry White Chemists Carvedilol 6.25 mg)

insert in the columns in the order indicated:

Carvedilol Tablet 6.25 mg Oral Vedilol 6.25 Spirit Pharmaceuticals Pty Ltd 67 109 225 747

1. Schedule 1, items dealing with Chorionic Gonadotrophin

omit from the columns in the order indicated (wherever occurring):

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, after items dealing with Desmopressin

insert in the columns in the order indicated:

Desvenlafaxine	Tablet (extended release) 100 mg (as succinate)	Oral	Pristiq	Wyeth Australia Pty Limited	16 000 296 211
Desvenlafaxine	Tablet (extended release) 50 mg (as succinate)	Oral	Pristiq	Wyeth Australia Pty Limited	16 000 296 211

1. Schedule 1, item dealing with Etonogestrel

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, items dealing with Follitropin Beta

omit from the columns in the order indicated (wherever occurring):

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, items dealing with Influenza Vaccine

omit from the column headed “Form” (wherever occurring):

A/Solomon Islands/3/2006

and substitute:

A/Brisbane/59/2007

1. Schedule 1, after item dealing with Lisinopril in the form Tablet 10 mg (Zestril)

insert in the columns in the order indicated:

Lisinopril Tablet 20 mg Oral APO-Lisinopril Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Lisinopril in the form Tablet 20 mg (Zestril)

insert in the columns in the order indicated:

Lisinopril Tablet 5 mg Oral APO-Lisinopril Apotex Pty Ltd 52 096 916 148

1. Schedule 1, after item dealing with Meloxicam in the form Capsule
   15 mg (Mobic)

insert in the columns in the order indicated:

Meloxicam Capsule 15 mg Oral Movalis 15 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Meloxicam in the form Capsule
   7.5 mg (Mobic)

insert in the columns in the order indicated:

Meloxicam Capsule 7.5 mg Oral Movalis 7.5 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg (Metformin generichealth)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Metformin Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg (Metformin generichealth)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Metformin Ranbaxy Ranbaxy Australia Pty Limited 17 110 871 826

1. Schedule 1, item dealing with Mianserin in the form Tablet containing mianserin hydrochloride 10 mg (Tolvon)

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Mianserin in the form Tablet containing mianserin hydrochloride 20 mg (Tolvon)

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, after item dealing with Minoxidil

insert in the columns in the order indicated:

Mirtazapine Tablet 15 mg Oral Axit 15 Alphapharm Pty Ltd 93 002 359 739

1. Schedule 1, items dealing with Mirtazapine

omit from the columns in the order indicated (wherever occurring):

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Nandrolone Decanoate

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Oestradiol in the form Transdermal gel
   1 mg (as hemihydrate) in 1 g sachet, 28

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, items dealing with Oestriol

omit from the columns in the order indicated (wherever occurring):

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Pancrelipase in the form Capsule (containing enteric coated microspheres) providing not less than 10,000 BP units of lipase activity

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Protein hydrolysate formula with medium chain triglycerides in the form Oral powder 450 g
   (Pepti-Junior)

omit from the columns in the order indicated:

Oral powder 450 g (Pepti-Junior) Pepti-Junior

and substitute:

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

1. Schedule 1, after item dealing with Simvastatin in the form Tablet
   10 mg (Simvastatin-DP)

insert in the columns in the order indicated:

Simvastatin

Tablet 10 mg

Oral

Simvastatin-Spirit 10

Spirit Pharmaceuticals Pty Ltd

67 109 225 747

1. Schedule 1, after item dealing with Simvastatin in the form Tablet
   20 mg (Simvastatin-DP)

insert in the columns in the order indicated:

Simvastatin

Tablet 20 mg

Oral

Simvastatin-Spirit 20

Spirit Pharmaceuticals Pty Ltd

67 109 225 747

1. Schedule 1, after item dealing with Simvastatin in the form Tablet
   40 mg (Simvastatin-DP)

insert in the columns in the order indicated:

Simvastatin

Tablet 40 mg

Oral

Simvastatin-Spirit 40

Spirit Pharmaceuticals Pty Ltd

67 109 225 747

1. Schedule 1, after item dealing with Simvastatin in the form Tablet
   80 mg (Simvastatin-DP)

insert in the columns in the order indicated:

Simvastatin

Tablet 80 mg

Oral

Simvastatin-Spirit 80

Spirit Pharmaceuticals Pty Ltd

67 109 225 747

1. Schedule 1, after item dealing with Sodium Lactate Compound

insert in the columns in the order indicated:

Sorafenib

Tablet 200 mg (as tosylate)

Oral

Nexavar

Bayer Australia Ltd

22 000 138 714

1. Schedule 1, items dealing with Testosterone in the form Capsule containing testosterone undecanoate 40 mg

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Testosterone in the form Injection containing testosterone esters (20 mg testosterone propionate, 40 mg testosterone phenylpropionate, 40 mg testosterone isocaproate) in
   1 mL

omit from the columns in the order indicated:

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, item dealing with Testosterone in the form Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate,
   100 mg testosterone decanoate) in 1 mL

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

isocaprate

and substitute:

   isocaproate

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

Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, items dealing with Testosterone in the forms Subcutaneous implant 100 mg and Subcutaneous implant 200 mg

omit from the columns in the order indicated:

Organon (Australia) Pty Limited Organon (Australia) Pty Limited 20 008 454 635

and substitute:

Schering-Plough Pty Limited Schering-Plough Pty Limited 57 000 235 245

1. Schedule 1, items dealing with Trandolapril

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

Trandolapril Capsule 1 mg Oral Odrik Abbott Australasia Pty Ltd 95 000 180 389

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

Trandolapril Capsule 2 mg Oral Odrik Abbott Australasia Pty Ltd 95 000 180 389

1. Schedule 1, after items dealing with Trimethoprim with Sulfamethoxazole

insert in the columns in the order indicated:

Triptorelin	Powder for I.M. injection (prolonged release) 11.25 mg (as embonate) with solvent, syringe and needles	Injection	Diphereline	Ipsen Pty Ltd	47 095 036 909
Triptorelin	Powder for I.M. injection (prolonged release) 3.75 mg (as embonate) with solvent, syringe and needles	Injection	Diphereline	Ipsen Pty Ltd	47 095 036 909

1. Schedule 1, after items dealing with Vinorelbine

insert in the columns in the order indicated:

Voriconazole	Tablet 200 mg	Oral	Vfend	Pfizer Australia Pty Ltd	50 008 422 348
Voriconazole	Tablet 50 mg	Oral	Vfend	Pfizer Australia Pty Ltd	50 008 422 348