National Health Act 1953 - Amendment determination under section 84af - responsible persons (No. PB 94 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 94 of 2008

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 1^st SEPTEMBER 2008

DIANA MACDONELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 October 2008.

2              Amendment of PB 76 of 2008

Schedule 1 amends PB 76 of 2008.

Schedule 1        Amendments

[1]            Schedule 1, after item dealing with Amlodipine in the form Tablet
10 mg (as besylate) (Norvasc)

insert in the columns in the order indicated:

Amlodipine Tablet 10 mg (as besylate) Oral Ozlodip Ranbaxy Australia Pty Limited 17 110 871 826

[2]            Schedule 1, after item dealing with Amlodipine in the form Tablet 5 mg (as besylate) (Norvasc)

insert in the columns in the order indicated:

Amlodipine Tablet 5 mg (as besylate) Oral Ozlodip Ranbaxy Australia Pty Limited 17 110 871 826

[3]            Schedule 1, after item dealing with Amoxycillin in the form Capsule 250 mg (as trihydrate) (Amoxycillin-DP)

insert in the columns in the order indicated:

Amoxycillin Capsule 250 mg (as trihydrate) Oral APO-Amoxycillin Apotex Pty Ltd 52 096 916 148

[4]            Schedule 1, after item dealing with Amoxycillin in the form Capsule 500 mg (as trihydrate) (Amoxycillin-DP)

insert in the columns in the order indicated:

Amoxycillin Capsule 500 mg (as trihydrate) Oral APO-Amoxycillin Apotex Pty Ltd 52 096 916 148

[5]            Schedule 1, omit item dealing with Amoxycillin in the form Tablet, chewable, 250 mg (as trihydrate)

[6]            Schedule 1, item dealing with Biperiden in the form Tablet containing biperiden hydrochloride 2 mg

omit from the columns in the order indicated:

Abbott Australasia Pty Ltd 95 000 180 389

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

[7]            Schedule 1, after item dealing with Cisplatin in the form I.V. injection 100 mg in 100 mL (Hospira Pty Limited)

insert in the columns in the order indicated:

Cisplatin I.V. injection 100 mg in 100 mL Injection Pfizer Australia Pty Ltd Pfizer Australia Pty Ltd 50 008 422 348

[8]            Schedule 1, after item dealing with Enoxaparin in the form Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL
pre-filled syringe (Clexane)

insert in the columns in the order indicated:

Enoxaparin Solution for injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in
0.4 mL Injection Clexane sanofi-aventis Australia Pty Ltd 31 008 558 807

[9]            Schedule 1, item dealing with Erythromycin in the form Powder for I.V. infusion 1 g (as lactobionate) (Erythrocin-I.V.)

omit from the columns in the order indicated:

Abbott Australasia Pty Ltd 95 000 180 389

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

[10]          Schedule 1, item dealing with Erythromycin in the form Powder for oral liquid 200 mg (as ethyl succinate) per 5 mL, 100 mL (E.E.S. 200)

omit from the columns in the order indicated:

Abbott Australasia Pty Ltd 95 000 180 389

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

[11]          Schedule 1, item dealing with Erythromycin in the form Powder for oral liquid 400 mg (as ethyl succinate) per 5 mL, 100 mL (E.E.S. Granules)

omit from the columns in the order indicated:

Abbott Australasia Pty Ltd 95 000 180 389

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

[12]          Schedule 1, item dealing with Erythromycin in the form Tablet 400 mg (as ethyl succinate)  (E.E.S. 400 Filmtab)

omit from the columns in the order indicated:

Abbott Australasia Pty Ltd 95 000 180 389

and substitute:

Link Medical Products Pty Ltd 73 010 971 516

[13]          Schedule 1, after item dealing with Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL (Diflucan)

insert in the columns in the order indicated:

Fluconazole Solution for I.V. infusion 100 mg in
50 mL Injection Fluconazole Hexal Sandoz Pty Ltd 60 075 449 553

[14]          Schedule 1, after item dealing with Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL (Diflucan)

insert in the columns in the order indicated:

Fluconazole Solution for I.V. infusion 200 mg in 100 mL Injection Fluconazole Hexal Sandoz Pty Ltd 60 075 449 553

[15]          Schedule 1, after item dealing with Gabapentin in the form Capsule  400 mg (Pendine 400)

insert in the columns in the order indicated:

Gabapentin Tablet 600 mg Oral Gabahexal 600mg Sandoz Pty Ltd 60 075 449 553

[16]          Schedule 1, items dealing with Hydromorphone

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

Abbott Australasia Pty Ltd 95 000 180 389

and substitute:

Mundipharma Pty Limited 87 081 322 509

[17]          Schedule 1, after item dealing with Lamotrigine in the form Tablet
100 mg (Lamotrigine generichealth)

insert in the columns in the order indicated:

Lamotrigine Tablet 100 mg Oral Lamotrigine Sandoz Sandoz Pty Ltd 60 075 449 553

[18]          Schedule 1, after item dealing with Lamotrigine in the form Tablet
200 mg (Lamotrigine generichealth)

insert in the columns in the order indicated:

Lamotrigine Tablet 200 mg Oral Lamotrigine Sandoz Sandoz Pty Ltd 60 075 449 553

[19]          Schedule 1, after item dealing with Lamotrigine in the form Tablet
25 mg (Lamotrigine generichealth)

insert in the columns in the order indicated:

Lamotrigine Tablet 25 mg Oral Lamotrigine Sandoz Sandoz Pty Ltd 60 075 449 553

[20]          Schedule 1, after item dealing with Lamotrigine in the form Tablet
50 mg (Lamotrigine generichealth)

insert in the columns in the order indicated:

Lamotrigine Tablet 50 mg Oral Lamotrigine Sandoz Sandoz Pty Ltd 60 075 449 553

[21]          Schedule 1, after items dealing with Paclitaxel

insert in the columns in the order indicated:

Paliperidone Tablet 12 mg (prolonged release) Oral Invega Janssen-Cilag Pty Ltd 47 000 129 975

[22]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg (Pravastatin 10)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
10 mg Oral Pravastatin generichealth Generic Health Pty Ltd 93 110 617 859

[23]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 10 mg (Pravastatin-DP)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
10 mg Oral Pravastatin-GA 10 Ascent Pharmahealth Ltd 52 107 340 367

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

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
20 mg Oral Pravastatin generichealth Generic Health Pty Ltd 93 110 617 859

[25]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 20 mg (Pravastatin-DP)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
20 mg Oral Pravastatin-GA 20 Ascent Pharmahealth Ltd 52 107 340 367

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

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
40 mg Oral Pravastatin generichealth Generic Health Pty Ltd 93 110 617 859

[27]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 40 mg (Pravastatin-DP)

insert in the columns in the order indicated:

Pravastatin Tablet containing pravastatin sodium
40 mg Oral Pravastatin-GA 40 Ascent Pharmahealth Ltd 52 107 340 367

[28]          Schedule 1, after item dealing with Pravastatin in the form Tablet containing pravastatin sodium 80 mg (Pravachol)

insert in the columns in the order indicated:

Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Pravastatin generichealth	Generic Health Pty Ltd	93 110 617 859
Pravastatin	Tablet containing pravastatin sodium 80 mg	Oral	Pravastatin-GA 80	Ascent Pharmahealth Ltd	52 107 340 367

[29]          Schedule 1, item dealing with Reteplase

omit from the columns in the order indicated:

Roche Products Pty Ltd 70 000 132 865

and substitute:

Actavis Australia Pty Ltd 43 122 896 468

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

omit from the column headed “Brand”:

Sertraline-DP

and substitute:

Sertraline-GA

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

omit from the column headed “Brand”:

Sertraline-DP

and substitute:

Sertraline-GA