National Health Act 1953 Amendment determination under section 84AF responsible persons (No. PB 61 of 2008) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 61 of 2008

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

I, ANDREW MITCHELL, 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                            3 JUNE                2008

ANDREW MITCHELL

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment determination – responsible persons

1              Commencement

This instrument commences on 1 July 2008.

2              Amendment of PB 90 of 2007

Schedule 1 amends PB 90 of 2007.

Schedule 1        Amendments

[1]            Schedule 1, after items dealing with Amitriptyline

insert in the columns in the order indicated:

Amlodipine Tablet 10 mg (as besylate) Oral Amlodipine generichealth Generic Health Pty Ltd 93 110 617 859

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

insert in the columns in the order indicated:

Amlodipine Tablet 5 mg (as besylate) Oral Amlodipine generichealth Generic Health Pty Ltd 93 110 617 859

[3]            Schedule 1, after item dealing with Calcipotriol in the form Ointment
50 micrograms per g, 30 g

insert in the columns in the order indicated:

Calcipotriol Scalp solution
50 micrograms (as monohydrate) per mL, 30 mL Application Daivonex CSL Biotherapies Pty Ltd 66 120 398 067

[4]            Schedule 1, after items dealing with Cimetidine

insert in the columns in the order indicated:

Cinacalcet	Tablet 30 mg (as hydrochloride)	Oral	Sensipar	Amgen Australia Pty Limited	31 051 057 428
Cinacalcet	Tablet 60 mg (as hydrochloride)	Oral	Sensipar	Amgen Australia Pty Limited	31 051 057 428
Cinacalcet	Tablet 90 mg (as hydrochloride)	Oral	Sensipar	Amgen Australia Pty Limited	31 051 057 428

[5]            Schedule 1, after items dealing with Cyproterone

insert in the columns in the order indicated:

Cystine with carbohydrate Sachets of oral powder 4 g containing 500 mg cystine, 30 (Cystine Amino Acid Supplement) Oral Cystine Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254

[6]            Schedule 1, items dealing with Dexamethasone

omit from the columns in the order indicated:

Dexamethasone Injection containing dexamethasone sodium phosphate equivalent to 120 mg dexamethasone phosphate in 5 mL Injection Hospira Australia Pty Ltd Hospira Australia Pty Ltd 58 097 064 330

[7]            Schedule 1, item dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL

omit from the column headed “Brand”:

LeucovorinCalcium (Hospira Australia Pty Ltd)

and substitute:

LeucovorinCalcium (Hospira Pty Limited)

[8]            Schedule 1, items dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

omit from the column headed “Brand”:

LeucovorinCalcium (Hospira Australia Pty Ltd)

and substitute:

LeucovorinCalcium (Hospira Pty Limited)

[9]            Schedule 1, item dealing with Folinic acid in the form Tablet containing calcium folinate equivalent to 15 mg folinic acid

omit from the column headed “Brand”:

LeucovorinCalcium (Hospira Australia Pty Ltd)

and substitute:

LeucovorinCalcium (Hospira Pty Limited)

[10]          Schedule 1, items dealing with Hydroxocobalamin

omit from the columns in the order indicated:

Hydroxocobalamin Injection 1 mg (as acetate) in 1 mL Injection Goldshield Hydroxocobalamin Hospira Australia Pty Ltd 58 097 064 330

[11]          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/Solomon Islands/3/2006 (H₁N₁)-like strain
7.5 micrograms haemagglutinin; A/Brisbane/10/2007 (H₃N₂)-like strain
7.5 micrograms haemagglutinin; B/Florida/4/2006-like strain 7.5 micrograms haemagglutinin;
0.25 mL pre-filled syringe Injection Fluvax Junior CSL Biotherapies Pty Ltd 66 120 398 067

[12]          Schedule 1, after item dealing with Melphalan

insert in the columns in the order indicated:

Memantine	Oral drops containing memantine hydrochloride 10 mg per g, 50 g	Oral	Ebixa	Lundbeck Australia Pty Ltd	86 070 094 290
Memantine	Tablet containing memantine hydrochloride 10 mg	Oral	Ebixa	Lundbeck Australia Pty Ltd	86 070 094 290

[13]          Schedule 1, after item dealing with Metronidazole in the form
I.V. infusion 500 mg in 100 mL (Baxter Healthcare Pty Ltd)

insert in the columns in the order indicated:

Metronidazole I.V. infusion 500 mg in 100 mL Injection DBL Metronidazole Intravenous Infusion Hospira Pty Limited 13 107 058 328

[14]          Schedule 1, items dealing with Oestradiol in the form Transdermal patches 2 mg, 4

omit from the columns in the order indicated:

Oestradiol Transdermal patches
2 mg, 4 Transdermal Femtran 25 iNova Pharmaceuticals (Australia) Pty Ltd 88 000 222 408

[15]          Schedule 1, items dealing with Oestradiol in the form Transdermal patches 3.8 mg, 4

omit from the columns in the order indicated:

Oestradiol Transdermal patches
3.8 mg, 4 Transdermal Femtran 50 iNova Pharmaceuticals (Australia) Pty Ltd 88 000 222 408

[16]          Schedule 1, items dealing with Oestradiol in the form Transdermal patches 7.6 mg, 4

omit from the columns in the order indicated:

Oestradiol Transdermal patches
7.6 mg, 4 Transdermal Femtran 100 iNova Pharmaceuticals (Australia) Pty Ltd 88 000 222 408

[17]          Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone in the form Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches
510 micrograms oestradiol (as hemihydrate) with 4.8 mg norethisterone acetate

omit from the column headed “Form (strength, type, size, etc.)”:

4.33 mg

and substitute:

780 micrograms

[18]          Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone in the form Pack containing 4 transdermal patches 4.33 mg oestradiol (as hemihydrate) and 4 transdermal patches
620 micrograms oestradiol (as hemihydrate) with 2.7 mg norethisterone acetate

omit from the column headed “Form (strength, type, size, etc.)”:

4.33 mg

and substitute:

780 micrograms

[19]          Schedule 1, after item dealing with Perindopril in the form Tablet
containing perindopril erbumine 2 mg (GenRx Perindopril)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine
2 mg Oral Indopril 2 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

[20]          Schedule 1, after item dealing with Perindopril in the form Tablet
containing perindopril erbumine 4 mg (GenRx Perindopril)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine
4 mg Oral Indopril 4 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

[21]          Schedule 1, after item dealing with Perindopril in the form Tablet
containing perindopril erbumine 8 mg (GenRx Perindopril)

insert in the columns in the order indicated:

Perindopril Tablet containing perindopril erbumine
8 mg Oral Indopril 8 Sigma Pharmaceuticals (Australia) Pty Ltd 88 004 118 594

[22]          Schedule 1, items dealing with Phenoxymethylpenicillin

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

Phenoxymethylpenicillin	Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL	Oral	Abbocillin-V	Sigma Pharmaceuticals (Australia) Pty Ltd	88 004 118 594
Phenoxymethylpenicillin	Oral suspension 125 mg (as benzathine) per 5 mL, 100 mL	Oral	Cilicaine V	Fawns and McAllan Proprietary Limited	16 004 296 066

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

Phenoxymethylpenicillin	Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL	Oral	Abbocillin-V	Sigma Pharmaceuticals (Australia) Pty Ltd	88 004 118 594
Phenoxymethylpenicillin	Oral suspension 250 mg (as benzathine) per 5 mL, 100 mL	Oral	Cilicaine V	Fawns and McAllan Proprietary Limited	16 004 296 066

[23]          Schedule 1, after item dealing with Rivastigmine in the form Oral solution 2 mg (as hydrogen tartrate) per mL, 120 mL

insert in the columns in the order indicated:

Rivastigmine	Transdermal patch 18 mg	Transdermal	Exelon Patch 10	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160
Rivastigmine	Transdermal patch 9 mg	Transdermal	Exelon Patch 5	Novartis Pharmaceuticals Australia Pty Limited	18 004 244 160

[24]          Schedule 1, after items dealing with Tenecteplase

insert in the columns in the order indicated:

Terbinafine Cream containing terbinafine hydrochloride 10 mg per g, 15 g Application Lamisil (Novartis Consumer Health Australasia Pty Ltd) Novartis Consumer Health Australasia Pty Ltd 46 004 535 513

[25]          Schedule 1, items dealing with Terbinafine in the form Tablet 250 mg (as hydrochloride)

omit from the column headed “Brand”:

Lamisil

and substitute:

Lamisil (Novartis Pharmaceuticals Australia Pty Limited)

[26]          Schedule 1, after items dealing with Tropisetron

insert in the columns in the order indicated:

Tyrosine with carbohydrate Sachets of oral powder 4 g containing 1 g tyrosine, 30 (Tyrosine Amino Acid Supplement) Oral Tyrosine Amino Acid Supplement Vitaflo Australia Pty Limited 82 097 161 254

[27]          Schedule 1, in all instances where Hospira Australia Pty Ltd appears in the column headed “Brand”

omit:

Hospira Australia Pty Ltd

and substitute:

Hospira Pty Limited

[28]          Schedule 1, in all instances where Hospira Australia Pty Ltd appears in the column headed “Responsible Person”

omit from the columns in the order indicated:

Hospira Australia Pty Ltd 58 097 064 330

and substitute:

Hospira Pty Limited 13 107 058 328