National Health Act 1953 Amendment Determination under section 84AF Responsible persons (No. PB 8 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 8 of 2008

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

I, STEPHEN DELLAR, 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 14 December 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 January 2008.

2              Amendment of PB 90 of 2007

Schedule 1 amends PB 90 of 2007.

Schedule 1        Amendments

[1]            Schedule 1, items dealing with Amoxycillin

omit from the columns in the order indicated:

Amoxycillin Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL Oral Amohexal Sandoz Pty Ltd 60 075 449 553

[2]            Schedule 1, items dealing with Calcium

omit from the columns in the order indicated:

Calcium Tablet 600 mg (as carbonate) Oral Caltrate Wyeth Consumer Healthcare Pty Limited 75 000 477 154

[3]           Schedule 1, after item dealing with Cefaclor in the form Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Keflor)

insert in the columns in the order indicated:

Cefaclor Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL Oral Ozcef Ranbaxy Australia  Pty Limited 17 110 871 826

[4]            Schedule 1, after item dealing with Cefaclor in the form Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Keflor)

insert in the columns in the order indicated:

Cefaclor Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL Oral Ozcef Ranbaxy Australia  Pty Limited 17 110 871 826

[5]            Schedule 1, after items dealing with Celecoxib

insert in the columns in the order indicated:

Cephalexin Capsule 250 mg (anhydrous) Oral Cephabell Bellwether Pharma Ltd 15 109 403 287

[6]            Schedule 1, after item dealing with Cephalexin in the form Capsule 250 mg (anhydrous) (Terry White Chemists Cephalexin)

insert in the columns in the order indicated:

Cephalexin Capsule 500 mg (anhydrous) Oral Cephabell Bellwether Pharma Ltd 15 109 403 287

[7]            Schedule 1, items dealing with Ciprofloxacin

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

Ciprofloxacin Tablet 250 mg (as hydrochloride) Oral Ciprofloxacin-BC Sandoz Pty Ltd 60 075 449 553

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

Ciprofloxacin Tablet 500 mg (as hydrochloride) Oral Ciprofloxacin-BC Sandoz Pty Ltd 60 075 449 553

[8]           Schedule 1, item dealing with Diphenoxylate with Atropine in the form Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms

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

Lofenoxal Pfizer Australia Pty Ltd 50 008 422 348

and substitute:

Lofenoxal Biotech Pharmaceuticals Pty Ltd 91 009 701 517

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

Lomotil Pfizer Australia Pty Ltd 50 008 422 348

and substitute:

Lomotil Biotech Pharmaceuticals Pty Ltd 91 009 701 517

[9]            Schedule 1, items dealing with Glucose Indicator — Blood

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

Glucose Indicator — Blood Discs containing electrode sensors, 10 sensors per disc, 5 For external use Ascensia Glucodisc Bayer Australia Ltd 22 000 138 714

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

Glucose Indicator — Blood Electrode strips, 50 (Ascensia Elite) For external use Ascensia Elite Bayer Australia Ltd 22 000 138 714

[10]          Schedule 1, after items dealing with Indomethacin

insert 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/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 Injection Vaxigrip Junior Sanofi Pasteur Pty Ltd 79 085 258 797

[11]          Schedule 1, items dealing with Oestradiol

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

Oestradiol Transdermal patches 3.28 mg, 8 Transdermal Menorest 37.5 Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

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

Oestradiol Transdermal patches 4.33 mg, 8 Transdermal Menorest 50 Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

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

Oestradiol Transdermal patches 6.57 mg, 8 Transdermal Menorest 75 Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

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

Oestradiol Transdermal patches 8.66 mg, 8 Transdermal Menorest 100 Novartis Pharmaceuticals Australia Pty Limited 18 004 244 160

[12]          Schedule 1, after item dealing with Paracetamol in the form Tablet
500 mg (Panamax)

insert in the columns in the order indicated:

Paracetamol Tablet 500 mg Oral Paracetamol Sandoz Sandoz Pty Ltd 60 075 449 553

[13]          Schedule 1, items dealing with Paroxetine in the form Tablet
20 mg (as hydrochloride)

omit from the columns in the order indicated:

Paroxetine Tablet 20 mg (as hydrochloride) Oral Oxetine Sandoz Pty Ltd 60 075 449 553

[14]          Schedule 1, after item dealing with Paroxetine in the form Tablet
20 mg (as hydrochloride) (Paroxetine 20)

insert in the columns in the order indicated:

Paroxetine Tablet 20 mg (as hydrochloride) Oral Paroxetine Sandoz Sandoz Pty Ltd 60 075 449 553

[15]          Schedule 1, after item dealing with Paroxetine in the form Tablet
20 mg (as hydrochloride) (Paroxetine Sandoz)

insert in the columns in the order indicated:

Paroxetine Tablet 20 mg (as hydrochloride) Oral Paroxetine Winthrop Sandoz Pty Ltd 60 075 449 553

[16]         Schedule 1, items dealing with Pilocarpine

omit from the columns in the order indicated:

Pilocarpine	Eye drops containing pilocarpine hydrochloride 5 mg per mL, 15 mL	Application to the eye	P.V. Carpine	Allergan Australia Pty Limited	85 000 612 831
Pilocarpine	Eye drops containing pilocarpine hydrochloride 5 mg per mL, 15 mL	Application to the eye	Pilopt	Allergan Australia Pty Limited	85 000 612 831

[17]          Schedule 1, after item dealing with Sertraline in the form Tablet
100 mg (as hydrochloride) (Sertraline 100)

insert in the columns in the order indicated:

Sertraline Tablet 100 mg (as hydrochloride) Oral Sertraline generichealth Generic Health Pty Ltd 93 110 617 859

[18]          Schedule 1, after item dealing with Sertraline in the form Tablet
50 mg (as hydrochloride) (Sertraline 50)

insert in the columns in the order indicated:

Sertraline Tablet 50 mg (as hydrochloride) Oral Sertraline generichealth Generic Health Pty Ltd 93 110 617 859

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

insert in the columns in the order indicated:

Simvastatin Tablet 10 mg Oral Simvastatin generichealth Generic Health Pty Ltd 93 110 617 859

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

insert in the columns in the order indicated:

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

[21]          Schedule 1, after item dealing with Simvastatin in the form Tablet
40 mg (Simvar 40)

insert in the columns in the order indicated:

Simvastatin Tablet 40 mg Oral Simvastatin generichealth Generic Health Pty Ltd 93 110 617 859

[22]          Schedule 1, after item dealing with Simvastatin in the form Tablet
80 mg (Simvar 80)

insert in the columns in the order indicated:

Simvastatin Tablet 80 mg Oral Simvastatin generichealth Generic Health Pty Ltd 93 110 617 859

[23]          Schedule 1, items dealing with Tamoxifen in the form Tablet
20 mg (as citrate)

omit from the column headed “Brand”:

Tamoxifen Hexal

and substitute:

Tamoxifen Sandoz

[24]         Schedule 1, omit items dealing with Thioridazine