National Health Act 1953 Amendment determination under section 84AF Responsible Persons (No. PB 80 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 80 of 2007

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

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under section 84AF of the National Health Act 1953.

Dated 2 October 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Determination – Responsible Persons

1              Commencement

This instrument commences on 1 November 2007.

2              Amendment of PB 50 of 2007

Schedule 1 amends PB 50 of 2007.

Schedule 1        Amendments

[1]            Schedule 1, after items dealing with Bleomycin

insert in the columns in the order indicated:

Bortezomib Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) Injection Velcade Janssen-Cilag Pty Ltd 47 000 129 975

[2]            Schedule 1, after item dealing with Ceftriaxone in the form Powder for injection 1 g (as sodium) (DBL Ceftriaxone)

insert in the columns in the order indicated:

Ceftriaxone Powder for injection 1 g (as sodium) Injection Max Pharma Pty Ltd Max Pharma Pty Ltd 93 121 857 878

[3]            Schedule 1, after items dealing with Celecoxib

insert in the columns in the order indicated:

Cephalexin Capsule 250 mg (anhydrous) Oral Cephalexin-Lupin Max Pharma Pty Ltd 93 121 857 878

[4]            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 Cephalexin-Lupin Max Pharma Pty Ltd 93 121 857 878

[5]            Schedule 1, after item dealing with Glucose Indicator — Blood in the form Electrode strips, 50 (Omnitest Plus)

insert in the columns in the order indicated:

Glucose Indicator — Blood Electrode strips, 50 (Optium Omega) For external use (Optium Omega) Abbott Australasia Pty Ltd 95 000 180 389

[6]           Schedule 1, after items dealing with Ifosfamide

insert in the columns in the order indicated:

Imatinib	Tablet 100 mg (as mesylate)	Oral	Glivec	Novartis Pharmaceuticals Australia Pty Ltd	18 004 244 160
Imatinib	Tablet 400 mg (as mesylate)	Oral	Glivec	Novartis Pharmaceuticals Australia Pty Ltd	18 004 244 160

[7]           Schedule 1, item dealing with Loperamide in the form Capsule containing loperamide hydrochloride 2 mg (Imodium)

omit in the columns in the order indicated:

Janssen-Cilag Pty Ltd 47 000 129 975

and substitute:

Johnson & Johnson Pacific Pty Ltd 73 001 121 446

[8]           Schedule 1, after item dealing with Meloxicam in the form Tablet
15 mg (GenRx Meloxicam)

insert in the columns in the order indicated:

Meloxicam	Tablet 15 mg	Oral	Meloxibell	Bellwether Pharma Limited	15 109 403 287
Meloxicam	Tablet 15 mg	Oral	Meloxicam Ranbaxy	Ranbaxy Australia Pty Limited	17 110 871 826

[9]            Schedule 1, after item dealing with Meloxicam in the form Tablet

15 mg (Moxicam 15)

insert in the columns in the order indicated:

Meloxicam Tablet 15 mg Oral Pharmacor Meloxicam 15 Pharmacor Limited 58 121 020 835

[10]          Schedule 1, after item dealing with Meloxicam in the form Tablet

7.5 mg (GenRx Meloxicam)

insert in the columns in the order indicated:

Meloxicam	Tablet 7.5 mg	Oral	Meloxibell	Bellwether Pharma Limited	15 109 403 287
Meloxicam	Tablet 7.5 mg	Oral	Meloxicam Ranbaxy	Ranbaxy Australia Pty Limited	17 110 871 826

[11]          Schedule 1, after item dealing with Meloxicam in the form Tablet

7.5 mg (Moxicam 7.5)

insert in the columns in the order indicated:

Meloxicam Tablet 7.5 mg Oral Pharmacor Meloxicam 7.5 Pharmacor Limited 58 121 020 835

[12]          Schedule 1, after item dealing with Mirtazapine in the form Tablet

30 mg (Axit 30)

insert in the columns in the order indicated:

Mirtazapine	Tablet 30 mg	Oral	Chem mart Mirtazapine	GenRx Pty Ltd	52 096 916 148
Mirtazapine	Tablet 30 mg	Oral	GenRx Mirtazapine	GenRx Pty Ltd	52 096 916 148

[13]          Schedule 1, after item dealing with Mirtazapine in the form Tablet

30 mg (Remeron)

insert in the columns in the order indicated:

Mirtazapine Tablet 30 mg Oral Terry White Chemists Mirtazapine GenRx Pty Ltd 52 096 916 148

[14]          Schedule 1, after item dealing with Perindopril with Indapamide in the form Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg (GenRx Perindopril/Indapamide 4/1.25)

insert in the columns in the order indicated:

Perindopril with Indapamide Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg Oral Perindo Combi 4/1.25 Alphapharm Pty Ltd 93 002 359 739

[15]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg (Terry White Chemists Pravastatin)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 20 mg Oral Vastoran Ranbaxy Australia Pty Ltd 17 110 871 826

[16]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg (Terry White Chemists Pravastatin)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium 40 mg Oral Vastoran Ranbaxy Australia Pty Ltd 17 110 871 826

[17]          Schedule 1, item dealing with Simvastatin in the form Tablet 5 mg

omit in the columns in the order indicated:

Simvastatin Tablet 5 mg Oral Simvastatin Winthrop sanofi-aventis Australia Pty Ltd 31 008 558 807

[18]         Schedule 1, item dealing with Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate in the form Enemas 3.125 g-450 mg-45 mg in 5 ml, 12

omit in the columns in the order indicated:

Pfizer Pty Ltd 50 008 422 348

and substitute:

Johnson & Johnson Pacific Pty Ltd 73 001 121 446

[19]          Schedule 1, after items dealing with Tacrolimus

insert in the columns in the order indicated:

Tamarindus indica seed polysaccharide Eye drops 10 mg per mL, 0.5 mL, 20 Application to the eye Visine Professional Johnson & Johnson Pacific Pty Ltd 73 001 121 446

[20]          Schedule 1, after item dealing with Vancomycin in the form Capsule 250 mg (250,000 I.U.) (as hydrochloride)

insert in the columns in the order indicated:

Vancomycin Powder for injection 1 g (1,000,000 I.U.) as hydrochloride Injection Hospira Australia Pty Ltd Hospira Australia Pty Ltd 58 097 064 330

1. Schedule 1, item dealing with Vancomycin in the form Powder for injection 500 mg (500,000 i.u.) as hydrochloride (Vancocin)

omit from the column headed “Brand”:

Vancocin

and substitute:

Vancocin CP