National Health Act 1953 Amendment determination under section 84AF (No. PB 63 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 63 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 14 August 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Determination – Responsible Persons

1              Commencement

This instrument commences on 1 September 2007.

2              Amendment of PB 50 of 2007

Schedule 1 amends PB 50 of 2007.

Schedule 1        Amendments

(section 2)

[1]           Schedule 1, after item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe

insert in the columns in the order indicated

Adalimumab Injection 40 mg in 0.8 mL pre-filled pen Injection Humira Abbott Australasia Pty Ltd 95 000 180 389

[2]           Schedule 1, item dealing with Ampicillin

omit from the columns in the order indicated:

Ampicillin	Capsule 250 mg (as trihydrate)	Oral	Alphacin 250	Alphapharm Pty Ltd	93 002 359 739
Ampicillin	Capsule 500 mg (as trihydrate)	Oral	Alphacin 500	Alphapharm Pty Ltd	93 002 359 739

[3]          Schedule 1, after item dealing with Cephazolin

insert in the columns in the order indicated

Cetuximab Solution for I.V. infusion 100 mg in 50 mL Injection Erbitux Merck Serono Australia Pty Ltd 72 006 900 830

[4]          Schedule 1, after item dealing with Codeine with Paracetamol in the form Tablet containing codeine phosphate 30 mg with paracetamol 500 mg, Codapane Forte

insert in the columns in the order indicated

Codeine with Paracetamol Tablet containing codeine phosphate 30 mg with paracetamol 500 mg Oral Comfarol Forte sanofi-aventis Australia Pty Ltd 31 008 558 807

[5]           Schedule 1, item dealing with Fluconazole in the form Solution for I.V. infusion 100 mg in 50 mL vial

omit from the column headed “Form”:

Solution for I.V. infusion 100 mg in 50 mL vial

and substitute:

Solution for I.V. infusion 100 mg in 50 mL

[6]           Schedule 1, item dealing with Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL vial

omit from the column headed “Form”:

Solution for I.V. infusion 200 mg in 100 mL vial

and substitute:

Solution for I.V. infusion 200 mg in 100 mL

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

insert in the columns in the order indicated

Fluconazole Solution for I.V. infusion 400 mg in 200 mL Injection Baxter Healthcare Pty Ltd Baxter Healthcare Pty Ltd 43 000 392 781

[8]           Schedule 1, after item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg, Fosinopril/HCT Sandoz 10mg/12.5mg

insert in the columns in the order indicated

Fosinopril with Hydrochlorothiazide Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg Oral Hyforil Ranbaxy Australia Pty Limited 17 110 871 826

[9]           Schedule 1, after item dealing with Fosinopril with Hydrochlorothiazide in the form Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg, Fosinopril/HCT Sandoz 20mg/12.5mg

insert in the columns in the order indicated

Fosinopril with Hydrochlorothiazide Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg Oral Hyforil Ranbaxy Australia Pty Limited 17 110 871 826

[10]         Schedule 1, item dealing with Levonorgestrel

omit from the columns in the order indicated:

Levonorgestrel Tablets 30 micrograms, 28 Oral Microval 28 Wyeth Australia Pty Limited 16 000 296 211

[11]         Schedule 1, item dealing with Lumiracoxib in the form Tablet 200 mg

omit from the column headed “Form”:

Tablet 200 mg

and substitute:

Tablet 100 mg

[12]         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 Meloxicam-GA Genepharm Limited 17 003 854 626

[13]         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 Meloxicam-GA Genepharm Limited 17 003 854 626

[14]         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-GA Genepharm Limited 17 003 854 626

[15]         Schedule 1, after item dealing with Ondansetron in the form I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL, Ondaz

insert in the columns in the order indicated

Ondansetron I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL Injection Onsetron Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[16]         Schedule 1, after item dealing with Ondansetron in the form I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL, Ondaz

insert in the columns in the order indicated

Ondansetron I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL Injection Onsetron Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[17]         Schedule 1, item dealing with "Phenex-1"

omit from the columns in the order indicated

“Phenex-1” Oral powder 350 g Oral Phenex-1 Abbott Australasia Pty Ltd 95 000 180 389

[18]         Schedule 1, after item dealing with Phenoxybenzamine in the form Capsule containing phenoxybenzamine hydrochloride 10 mg

insert in the columns in the order indicated

Phenoxybenzamine Capsules containing phenoxybenzamine hydrochloride 10 mg, 30 Oral Dibenyline Goldshield Healthcare (Australia) Pty Limited 91 118 106 684

[19]         Schedule 1, after item dealing with Ramipril in the form

Tablet 1.25 mg, Tritace 1.25 mg

insert in the columns in the order indicated

Ramipril Tablet 10 mg Oral Tritace sanofi-aventis Australia Pty Ltd 31 008 558 807

[20]         Schedule 1, after item dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 200 mg, Epilim EC

insert in the columns in the order indicated

Valproic Acid Tablet (enteric coated) containing sodium valproate 200 mg Oral Sodium Valproate Sandoz sanofi-aventis Australia Pty Ltd 31 008 558 807

[21]         Schedule 1, after item dealing with Valproic Acid in the form Tablet (enteric coated) containing sodium valproate 500 mg, Epilim EC

insert in the columns in the order indicated

Valproic Acid Tablet (enteric coated) containing sodium valproate 500 mg Oral Sodium Valproate Sandoz sanofi-aventis Australia Pty Ltd 31 008 558 807