National Health Act 1953 - Amendment determination under section 84af - responsible persons (No. PB 89 of 2010) (Cth)

Case

COMMONWEALTH OF AUSTRALIA

Instrument number PB 89 of 2010

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

I, DAVID LEARMONTH, Deputy Secretary, 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   17 September 2010

DAVID LEARMONTH

Deputy Secretary

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 October 2010.

2              Amendment of PB 69 of 2010

Schedule 1 amends PB 69 of 2010.

Schedule 1            Amendments

  1. Schedule 1, after item dealing with Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL

insert in 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 Amoxycillin/ Clavulanic Acid 500/125 generichealth Generic Health Pty Ltd  93 110 617 859

  1. Schedule 1, after item dealing with Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)

insert in 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 Amoxycillin/ Clavulanic Acid 875/125 generichealth Generic Health Pty Ltd  93 110 617 859

  1. Schedule 1, after item dealing with Electrolyte Replacement, Solution in the form Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium cluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L

insert in the columns in the order indicated:

Eletriptan Tablet 40 mg (as hydrobromide) Oral Relpax Pfizer Australia Pty Ltd  50 008 422 348
Eletriptan Tablet 80 mg (as hydrobromide) Oral Relpax Pfizer Australia Pty Ltd  50 008 422 348

  1. Schedule 1, after item dealing with Lamotrigine in the form Tablet 5 mg (Seaze 5)

insert in the columns in the order indicated:

Lamotrigine Tablet 50 mg Oral APO-Lamotrigine Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, items dealing with Lisinopril in the form Tablet 10 mg

omit from the columns in the order indicated:

Lisinopril Tablet 10 mg Oral Lisinobell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Lisinopril in the form Tablet 20 mg

omit from the columns in the order indicated:

Lisinopril Tablet 20 mg Oral Lisinobell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Lisinopril in the form Tablet 5 mg

omit from the columns in the order indicated:

Lisinopril Tablet 5 mg Oral Lisinobell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, after item dealing with Memantine  in the form Oral drops containing memantine hydrochloride 10 mg per g, 50 g (Ebixa)

insert in the columns in the order indicated:

Memantine Tablet containing memantine hydrochloride 10 mg Oral APO-Memantine Apotex Pty Ltd  52 096 916 148

  1. Schedule 1, after item dealing with Metformin in the form Tablet containing metformin hydrochloride 1 g (Formet 1000)

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 1 g Oral Glucohexal Sandoz Pty Ltd  60 075 449 553

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

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Glucohexal Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, items dealing with Metformin in the form Tablet containing metformin hydrochloride 500 mg

omit from the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 500 mg Oral Metforbell Bellwether Pharma Ltd  15 109 403 287

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

insert in the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Glucohexal Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, items dealing with Metformin in the form Tablet containing metformin hydrochloride 850 mg

omit from the columns in the order indicated:

Metformin Tablet containing metformin hydrochloride 850 mg Oral Metforbell Bellwether Pharma Ltd  15 109 403 287

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

insert in the columns in the order indicated:

Omeprazole Tablet 20 mg Oral Omeprazole generichealth Generic Health Pty Ltd  93 110 617 859

  1. Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Panto)

insert in the columns in the order indicated:

Pantoprazole Tablet (enteric coated) 20 mg (as sodium sesquihydrate) Oral Pantofast 20 Dr Reddy's Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoloc)

insert in the columns in the order indicated:

Pantoprazole Tablet (enteric coated) 20 mg (as sodium sesquihydrate) Oral Pantoprazole generichealth Generic Health Pty Ltd  93 110 617 859

  1. Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Panto)

insert in the columns in the order indicated:

Pantoprazole Tablet (enteric coated) 40 mg (as sodium sesquihydrate) Oral Pantofast 40 Dr Reddy's Laboratories (Australia) Pty Ltd  16 120 092 408

  1. Schedule 1, after item dealing with Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Pantoloc)

insert in the columns in the order indicated:

Pantoprazole Tablet (enteric coated) 40 mg (as sodium sesquihydrate) Oral Pantoprazole generichealth Generic Health Pty Ltd  93 110 617 859

  1. Schedule 1, after item dealing with Ranitidine in the form Tablet 300 mg (as hydrochloride) (Ranihexal)

insert in the columns in the order indicated:

Ranitidine Tablet 300 mg (as hydrochloride) Oral Ranitidine Sandoz Sandoz Pty Ltd  60 075 449 553

  1. Schedule 1, items dealing with Rosiglitazone with Metformin

omit from the columns in the order indicated:

Rosiglitazone with Metformin Tablet 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481
Rosiglitazone with Metformin Tablet 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481
Rosiglitazone with Metformin Tablet 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481
Rosiglitazone with Metformin Tablet 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481

and substitute:

Rosiglitazone with Metformin Tablet containing 2 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481
Rosiglitazone with Metformin Tablet containing 2 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481
Rosiglitazone with Metformin Tablet containing 4 mg rosiglitazone (as maleate) with 1 g metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481
Rosiglitazone with Metformin Tablet containing 4 mg rosiglitazone (as maleate) with 500 mg metformin hydrochloride Oral Avandamet GlaxoSmithKline Australia Pty Ltd  47 100 162 481

  1. Schedule 1, item dealing with Sertraline in the form Tablet 100 mg (as hydrochloride) (Xydep 100)

omit from the columns in the order indicated:

Pfizer Australia Pty Ltd 50 008 422 348

insert in the columns in the order indicated:

Ascent Pharmaceuticals Limited 17 003 854 626

  1. Schedule 1, item dealing with Sertraline in the form Tablet 50 mg (as hydrochloride) (Xydep 50)

omit from the columns in the order indicated:

Pfizer Australia Pty Ltd 50 008 422 348

insert in the columns in the order indicated:

Ascent Pharmaceuticals Limited 17 003 854 626

  1. Schedule 1, items dealing with Simvastatin in the form Tablet 10 mg

omit from the columns in the order indicated:

Simvastatin Tablet 10 mg Oral Simvabell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Simvastatin in the form Tablet 20 mg

omit from the columns in the order indicated:

Simvastatin Tablet 20 mg Oral Simvabell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Simvastatin in the form Tablet 40 mg

omit from the columns in the order indicated:

Simvastatin Tablet 40 mg Oral Simvabell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Simvastatin in the form Tablet 5 mg

omit from the columns in the order indicated:

Simvastatin Tablet 5 mg Oral Simvabell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Simvastatin in the form Tablet 80 mg

omit from the columns in the order indicated:

Simvastatin Tablet 80 mg Oral Simvabell Bellwether Pharma Ltd  15 109 403 287

  1. Schedule 1, items dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)

omit from the columns in the order indicated:

Terbinafine Tablet 250 mg (as hydrochloride) Oral Terbinafine-DP Ascent Pharmaceuticals Limited  17 003 854 626

  1. Schedule 1, after item dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride) (Terbinafine 250)

insert in the columns in the order indicated:

Terbinafine Tablet 250 mg (as hydrochloride) Oral Terbinafine-DRLA Dr Reddy's Laboratories (Australia) Pty Ltd  16 120 092 408

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.

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