National Health Act 1953 Amendment determination under section 84AF Responsible persons (No. PB 25 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 25 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 February   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 March 2008.

2              Amendment of PB 90 of 2007

Schedule 1 amends PB 90 of 2007.

Schedule 1        Amendments

[1]            Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without lysine and low in tryptophan, Oral powder 500 g (XLYS, LOW TRY Maxamaid)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without methionine Oral liquid 130 mL, 30 (HCU Cooler) Oral HCU Cooler Vitaflo Australia Pty Limited 82 097 161 254

1. Schedule 1, after item dealing with Amino acid formula with vitamins and minerals without phenylalanine, Sachets containing oral powder 50 g, 30 (XP Maxamum)

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine Oral liquid 130 mL, 30 (TYR Cooler) Oral TYR Cooler Vitaflo Australia Pty Limited 82 097 161 254

[3]            Schedule 1, after item dealing with Amoxycillin with clavulanic acid, Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (Curam 500/125)

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 GA-Amclav 500/125 Genepharm Limited 17 003 854 626

[4]              Schedule 1, after item dealing with Amoxycillin with clavulanic acid, Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (Curam 875/125)

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 GA-Amclav Forte 875/125 Genepharm Limited 17 003 854 626

[5]              Schedule 1, after item dealing with Citalopram, Tablet 20 mg (as hydrobromide) (Cipramil)

insert in the columns in the order indicated:

Citalopram Tablet 20 mg (as hydrobromide) Oral Citalobell Bellwether Pharma Ltd 15 109 403 287

[6]              Schedule 1, items dealing with Ipratropium, Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) per mL, 20 mL

omit from the columns in the order indicated:

Ipratropium Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) per mL, 20 mL Inhalation Atrovent Boehringer Ingelheim Pty Ltd 52 000 452 308

[7]              Schedule 1, after item dealing with Iron sucrose

insert in the columns in the order indicated:

Isoleucine with carbohydrate Sachets of oral powder
4 g containing 50 mg isoleucine, 30 (Isoleucine Amino Acid Supplement) Oral Isoleucine Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254

[8]               Schedule 1, items dealing with Mirtazapine, Tablet 30 mg

omit from the columns in the order indicated:

Mirtazapine Tablet 30 mg Oral Remeron Organon (Australia) Pty Limited 20 008 454 635

[9]              Schedule 1, after item dealing with Oxaliplatin, Powder for I.V. infusion 100 mg (Oxalatin)

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 100 mg Injection Oxaliplan 100 Willow Pharmaceuticals Pty Ltd 80 118 534 704

[10]            Schedule 1, after item dealing with Oxaliplatin, Powder for I.V. infusion 50 mg (Oxalatin)

insert in the columns in the order indicated:

Oxaliplatin Powder for I.V. infusion 50 mg Injection Oxaliplan 50 Willow Pharmaceuticals Pty Ltd 80 118 534 704

[11]            Schedule 1, after item dealing with Paroxetine, Tablet 20 mg (as hydrochloride) (Terry White Chemists Paroxetine)

insert in the columns in the order indicated:

Pemetrexed Powder for I.V. infusion 100 mg (as disodium heptahydrate) Injection Alimta Eli Lilly Australia Pty Ltd 39 000 233 992

[12]            Schedule 1, after item dealing with Tramadol, Tablet containing tramadol hydrochloride 50 mg (sustained release)

insert in the columns in the order indicated:

Trandolapril Capsule 1 mg Oral Dolapril 1 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[13]            Schedule 1, after item dealing with Trandolapril, Capsule 1 mg (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule 2 mg Oral Dolapril 2 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[14]            Schedule 1, after item dealing with Trandolapril, Capsule 2 mg, (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule 4 mg Oral Dolapril 4 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[15]            Schedule 1, after item dealing with Trandolapril, Capsule 4 mg (Tranalpha)

insert in the columns in the order indicated:

Trandolapril Capsule 500 micrograms Oral Dolapril 0.5 Arrow Pharmaceuticals Pty Ltd 17 003 144 170

[16]            Schedule 1, after item dealing with Valaciclovir

insert in the columns in the order indicated:

Valine with carbohydrate Sachets of oral powder
4 g containing 50 mg valine, 30 (Valine Amino Acid Supplement) Oral Valine Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254