National Health Act 1953 - Amendment Determination under section 84af - Responsible persons (No. PB 70 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 70 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 6 Sept 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Determination – Responsible Persons

1 Commencement

This instrument commences on 1 October 2007.

2 Amendment of PB 50 of 2007

Schedule 1 amends PB 50 of 2007.

Schedule 1 Amendments

(section 2)

[1] Schedule 1, omit item dealing with “Alfaré”

[2] Schedule 1, after item dealing with Alendronic Acid with Colecalciferol

insert in the columns in the order indicated:

Alginic acid with calcium carbonate and sodium bicarbonate

Oral liquid containing alginic acid as sodium alginate 1 g, calcium carbonate 320 mg and sodium bicarbonate 534 mg in 20 mL, 500 mL

Oral

Gaviscon P

Reckitt Benckiser (Australia) Pty Limited

17 003 274 655

[3] Schedule 1, items dealing with Aluminium Hydroxide - Dried with Magnesium Hydroxide, Oral suspension 200 mg-200 mg per 5 mL,
500 mL and Tablet 200 mg-200 mg

omit from the column headed “Listed Drug”:

Aluminium Hydroxide - Dried with Magnesium Hydroxide

and substitute:

Aluminium Hydroxide with Magnesium Hydroxide

[4] Schedule 1, item dealing with Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide

omit from the column headed “Listed Drug”:

Aluminium Hydroxide - Dried with Magnesium Trisilicate and Magnesium Hydroxide

and substitute:

Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide

[5] Schedule 1, after item dealing with Amiloride

insert in the columns in the order indicated:

Amino acid formula with vitamins and minerals without lysine and low in tryptophan	Oral powder 400 g (XLYS, LOW TRY Analog)	Oral	XLYS, LOW TRY Analog	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without lysine and low in tryptophan	Oral powder 500 g (XLYS, LOW TRY Maxamaid)	Oral	XLYS, LOW TRY Maxamaid	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without methionine	Oral powder 400 g (XMET Analog)	Oral	XMET Analog	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without methionine	Oral powder 500 g (XMET Maxamaid)	Oral	XMET Maxamaid	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without methionine	Oral powder 500 g (XMET Maxamum)	Oral	XMET Maxamum	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without methionine	Sachets containing oral powder 20 g, 30 (HCU gel)	Oral	HCU gel	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without methionine	Sachets containing oral powder 25 g, 30 (HCU express)	Oral	HCU express	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine	Oral powder 400 g (XMTVI Analog)	Oral	XMTVI Analog	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine	Oral powder 500 g (XMTVI Maxamaid)	Oral	XMTVI Maxamaid	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine	Oral powder 500 g (XMTVI Maxamum)	Oral	XMTVI Maxamum	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Oral liquid 125 mL, 30 (Lophlex LQ)	Oral	Lophlex LQ	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Oral liquid 130 mL, 30 (PKU Cooler 15)	Oral	PKU Cooler 15	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without phenylalanine	Oral liquid 174 mL, 30 (PKU Cooler 20)	Oral	PKU Cooler 20	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without phenylalanine	Oral liquid 250 mL (Easiphen)	Oral	Easiphen	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Oral liquid 87 mL, 30 (PKU Cooler 10)	Oral	PKU Cooler 10	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without phenylalanine	Oral powder 325 g (Phenex-2)	Oral	Phenex-2	Abbott Australasia Pty Ltd	95 000 180 389
Amino acid formula with vitamins and minerals without phenylalanine	Oral powder 400 g (Phenex-2)	Oral	Phenex-2	Abbott Australasia Pty Ltd	95 000 180 389
Amino acid formula with vitamins and minerals without phenylalanine	Oral powder 400 g (XP Analog)	Oral	XP Analog	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Oral powder 500 g (XP Maxamaid)	Oral	XP Maxamaid	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Oral powder 500 g (XP Maxamum)	Oral	XP Maxamum	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Sachets containing oral powder 20 g, 30 (PKU-gel)	Oral	PKU-gel	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without phenylalanine	Sachets containing oral powder 25 g, 30 (PKU-Express)	Oral	PKU-Express	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without phenylalanine	Sachets containing oral powder 27.8 g, 30 (Lophlex)	Oral	Lophlex	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Sachets containing oral powder 29 g, 30 (Minaphlex)	Oral	Minaphlex	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine	Sachets containing oral powder 50 g, 30 (XP Maxamum)	Oral	XP Maxamum	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine	Oral powder 400 g (XPhen, Tyr Analog)	Oral	XPhen, Tyr Analog	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine	Oral powder 500 g (XPhen, Tyr Maxamaid)	Oral	XPhen, Tyr Maxamaid	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine	Oral powder 500 g (XPhen, Tyr Maxamum)	Oral	XPhen, Tyr Maxamum	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine	Sachets containing oral powder 20 g, 30 (TYR gel)	Oral	TYR gel	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without phenylalanine and tyrosine	Sachets containing oral powder 25 g, 30 (TYR Express)	Oral	TYR Express	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral liquid 130 mL, 30 (MSUD Express Cooler)	Oral	MSUD Express Cooler	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 325 g (Ketonex-2)	Oral	Ketonex-2	Abbott Australasia Pty Ltd	95 000 180 389
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 350 g (Ketonex-1)	Oral	Ketonex-1	Abbott Australasia Pty Ltd	95 000 180 389
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 400 g (MSUD Analog)	Oral	MSUD Analog	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 500 g (MSUD AID III)	Oral	MSUD AID III	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 500 g (MSUD Maxamaid)	Oral	MSUD Maxamaid	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Oral powder 500 g (MSUD Maxamum)	Oral	MSUD Maxamum	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Sachets containing oral powder 20 g, 30 (MSUD-gel)	Oral	MSUD-gel	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Sachets containing oral powder 25 g, 30 (MSUD Express)	Oral	MSUD Express	Vitaflo Australia Pty Ltd	82 097 161 254
Amino acid formula with vitamins and minerals without valine, leucine and isoleucine	Sachets containing oral powder 29 g, 30 (Mapleflex)	Oral	Mapleflex	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine	Oral powder 400 g (XP Analog LCP)	Oral	XP Analog LCP	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without methionine, threonine and valine and low in isoleucine	Oral powder 200 g (XMTVI Asadon)	Oral	XMTVI Asadon	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without phenylalanine	Bars 42 g, 20 (Phlexy-10)	Oral	Phlexy-10	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without phenylalanine	Capsules 500 mg, 200 (Phlexy-10)	Oral	Phlexy-10	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without phenylalanine	Oral powder 250 g (PK AID II)	Oral	PK AID II	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without phenylalanine	Sachets containing oral powder 20 g, 30 (Phlexy-10 Drink Mix)	Oral	Phlexy-10 Drink Mix	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without phenylalanine	Tablets 1 g, 75 (Phlexy-10)	Oral	Phlexy-10	Nutricia Australia Pty Limited	99 076 246 752
Amino acid formula without phenylalanine, tyrosine and methionine	Oral powder 500 g (XPTM Tyrosidon)	Oral	XPTM Tyrosidon	Nutricia Australia Pty Limited	99 076 246 752
Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids	Oral powder 400 g (Neocate LCP)	Oral	Neocate LCP	Nutricia Australia Pty Limited	99 076 246 752
Amino acids — synthetic, formula	Oral powder 400 g (EleCare)	Oral	EleCare	Abbott Australasia Pty Ltd	95 000 180 389
Amino acids — synthetic, formula	Oral powder 400 g (Neocate Advance Tropical Flavour)	Oral	Neocate Advance Tropical Flavour	Nutricia Australia Pty Limited	99 076 246 752
Amino acids — synthetic, formula	Oral powder 400 g (Neocate Advance)	Oral	Neocate Advance	Nutricia Australia Pty Limited	99 076 246 752
Amino acids — synthetic, formula	Oral powder 400 g (Neocate)	Oral	Neocate	Nutricia Australia Pty Limited	99 076 246 752

[6] Schedule 1, after item dealing with Amisulpride, Tablet 100 mg, Amisulpride 100 Winthrop

insert in the columns in the order indicated:

Amisulpride

Tablet 100 mg

Oral

Amisulpride Sandoz

sanofi-aventis Australia Pty Ltd

31 008 558 807

[7] Schedule 1, after item dealing with Amisulpride, Tablet 200 mg, Amisulpride 200 Winthrop

insert in the columns in the order indicated:

Amisulpride

Tablet 200 mg

Oral

Amisulpride Sandoz

sanofi-aventis Australia Pty Ltd

31 008 558 807

[8] Schedule 1, after item dealing with Amisulpride, Tablet 400 mg, Amisulpride 400 Winthrop

insert in the columns in the order indicated:

Amisulpride

Tablet 400 mg

Oral

Amisulpride Sandoz

sanofi-aventis Australia Pty Ltd

31 008 558 807

[9] Schedule 1, items dealing with Bleomycin, Powder for injection containing bleomycin sulfate 15,000 I.U. (with required solvent), Blenamax, Blenoxane and Mayne Pharma Pty Ltd

omit from the column headed “Form”:

Powder for injection containing bleomycin sulfate 15,000 I.U. (with required solvent)

and substitute:

Powder for injection containing bleomycin sulfate 15,000 I.U. (with any determined brand of sodium chloride injection as the required solvent)

[10] Schedule 1, omit items dealing with Calcium Folinate and “Caprilon”

[11] Schedule 1, after item dealing with Carbimazole

insert in the columns in the order indicated:

Carbohydrate, fat, vitamins, minerals and trace elements	Oral powder 400 g (Energivit)	Oral	Energivit	Nutricia Australia Pty Limited	99 076 246 752
Carbohydrate, fat, vitamins, minerals and trace elements	Oral powder 400 g (Pro-Phree)	Oral	Pro-Phree	Abbott Australasia Pty Ltd	95 000 180 389

[12] Schedule 1, omit item dealing with "Carbohydrate Free Mixture"

[13] Schedule 1, item dealing with Cefepime, Powder for injection 1 g (as hydrochloride) (with required solvent)

omit from the column headed “Form”:

Powder for injection 1 g (as hydrochloride) (with required solvent)

and substitute:

Powder for injection 1 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

[14] Schedule 1, item dealing with Cefepime, Powder for injection 2 g (as hydrochloride) (with required solvent)

omit from the column headed “Form”:

Powder for injection 2 g (as hydrochloride) (with required solvent)

and substitute:

Powder for injection 2 g (as hydrochloride) (with any determined brand of sodium chloride injection as the required solvent)

[15] Schedule 1, items dealing with Ciclesonide, Pressurised inhalation 160 micrograms per dose, 120 doses (CFC-free formulation) and Pressurised inhalation 80 micrograms per dose, 120 doses (CFC-free formulation)

omit from the column headed “Responsible Person”:

Altana Pharma Pty Ltd

and substitute:

Nycomed Pty Ltd

[16] Schedule 1, item dealing with Cyclophosphamide, Powder for injection 1 g (anhydrous) (with required solvent)

omit from the column headed “Form”:

Powder for injection 1 g (anhydrous) (with required solvent)

and substitute:

Powder for injection 1 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)

[17] Schedule 1, item dealing with Cyclophosphamide, Powder for injection 2 g (anhydrous) (with required solvent)

omit from the column headed “Form”:

Powder for injection 2 g (anhydrous) (with required solvent)

and substitute:

Powder for injection 2 g (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)

[18] Schedule 1, item dealing with Cyclophosphamide, Powder for injection 500 mg (anhydrous) (with required solvent)

omit from the column headed “Form”:

Powder for injection 500 mg (anhydrous) (with required solvent)

and substitute:

Powder for injection 500 mg (anhydrous) (with any determined brand of sodium chloride injection as the required solvent)

[19] Schedule 1, omit items dealing with "Dialamine" and "Digestelact"

[20] Schedule 1, item dealing with Diphtheria and Tetanus Vaccine – Adsorbed

omit from the columns in the order indicated:

Diphtheria and Tetanus Vaccine - Adsorbed

Injection 0.5 mL ampoule

and substitute:

Diphtheria and tetanus vaccine, adsorbed

Injection 0.5 mL

[21] Schedule 1, item dealing with Diphtheria and Tetanus Vaccine – Adsorbed (Diluted)

omit from the column headed “Listed Drug”:

Diphtheria and Tetanus Vaccine – Adsorbed (Diluted)

and substitute:

Diphtheria and tetanus vaccine, adsorbed, diluted for adult use

[22] Schedule 1, omit items dealing with "Duocal", "Easiphen" and "Elecare"

[23] Schedule 1, item dealing with Electrolyte Replacement, Solution

omit from the column headed “Form”:

Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per

and substitute:

Electrolyte replacement solution containing sodium chloride 5.26 g, sodium acetate 3.68 g, sodium gluconate 5.02 g, potassium chloride 370 mg and magnesium chloride 300 mg per L, 1 L

[24] Schedule 1, omit item dealing with "Energivit"

[25] Schedule 1, item dealing with Esomeprazole and Clarithromycin and Amoxycillin

omit from the column headed “Form”:

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin

and substitute:

Pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxycillin 500 mg (as trihydrate)

[26] Schedule 1, after item dealing with Esomeprazole and Clarithromycin and Amoxycillin

insert in the columns in the order indicated:

Essential amino acids formula with minerals and vitamin C

Oral powder 200 g (Dialamine)

Oral

Dialamine

Nutricia Australia Pty Limited

99 076 246 752

[27] Schedule 1, after item dealing with Fluconazole, Capsule 100 mg, Fluconazole Hexal

insert in the columns in the order indicated:

Fluconazole

Capsule 100 mg

Oral

Fluconazole Winthrop

Sandoz Pty Ltd

60 075 449 553

[28] Schedule 1, after item dealing with Fluconazole, Capsule 200 mg, Fluconazole Hexal

insert in the columns in the order indicated:

Fluconazole

Capsule 200 mg

Oral

Fluconazole Winthrop

Sandoz Pty Ltd

60 075 449 553

[29] Schedule 1, after item dealing with Folic Acid, Tablet 500 micrograms

insert in the columns in the order indicated:

Folinic acid	Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL	Injection	Calcium Folinate Ebewe	InterPharma Pty Ltd	19 099 877 899
Folinic acid	Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL	Injection	Leucovorin Calcium	Pfizer Pty Limited	50 008 422 348
Folinic acid	Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL	Injection	Leucovorin Calcium	Mayne Pharma Pty Ltd	58 097 064 330
Folinic acid	Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL	Injection	Calcium Folinate Ebewe	InterPharma Pty Ltd	19 099 877 899
Folinic acid	Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL	Injection	Leucovorin Calcium	Mayne Pharma Pty Ltd	58 097 064 330
Folinic acid	Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL	Injection	Leucovorin Calcium	Pfizer Pty Limited	50 008 422 348
Folinic acid	Tablet containing calcium folinate equivalent to 15 mg folinic acid	Oral	Leucovorin Calcium	Mayne Pharma Pty Ltd	58 097 064 330

[30] Schedule 1, omit item dealing with Glucose Indicator—Blood, Electrode strips, 50 (GlucoMen Sensor)

[31] Schedule 1, omit items dealing with "HCU Express" and "HCU Gel"

[32] Schedule 1, item dealing with Insulin Glulisine

omit from the column headed “Brand”:

Apidra

and substitute:

Apidra SoloStar

[33] Schedule 1, omit item dealing with Insulin Neutral with Insulin Isophane, Injection (human) 30 units-70 units per mL, 10 mL, Mixtard 30/70

[34] Schedule 1, omit item dealing with Insulin Neutral with Insulin Isophane, Injection (human) 50 units-50 units per mL, 10 mL

[35] Schedule 1, omit item dealing with Insulin Neutral with Insulin Isophane, Injections (human), cartridges, 20 units-80 units per mL, 3 mL, 5

[36] Schedule 1, after item dealing with Irbesartan with Hydrochlorothiazide, Tablet 300 mg-12.5 mg, Karvezide 300/12.5

insert in the columns in the order indicated:

Irbesartan with Hydrochlorothiazide	Tablet 300 mg-25 mg	Oral	Avapro HCT 300/25	Bristol-Myers Squibb Australia Pty Ltd	33 004 333 322
Irbesartan with Hydrochlorothiazide	Tablet 300 mg-25 mg	Oral	Karvezide 300/25	sanofi-aventis Australia Pty Ltd	31 008 558 807

[37] Schedule 1, omit items dealing with "Karicare De-Lact", "Ketonex-1", "Ketonex-2", "Kindergen", "Locasol", "Lophlex", "Lophlex LQ", Lumiracoxib, "Mapleflex" and "Metabolic Mineral Mixture"

[38] Schedule 1, item dealing with Metoprolol, Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol

omit from the column headed “Form”:

Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol

and substitute:

Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets metoprolol succinate 95 mg (controlled release)

[39] Schedule 1, after items dealing with Miconazole

insert in the columns in the order indicated:

Milk powder — lactose free formula	Oral powder 900 g (Karicare De-Lact)	Oral	Karicare De-Lact	Nutricia Australia Pty Limited	99 076 246 752
Milk powder — lactose free formula	Oral powder 900 g (S-26 LF)	Oral	S-26 LF	Wyeth Australia Pty Limited	16 000 296 211
Milk powder — lactose modified	Oral powder 900 g (Digestelact)	Oral	Digestelact	Sharpe Laboratories Pty Ltd	55 001 334 854
Milk powder — synthetic	Low calcium oral powder 400 g (Locasol)	Oral	Locasol	Nutricia Australia Pty Limited	99 076 246 752
Milk protein and fat formula with vitamins and minerals — carbohydrate free	Oral powder 225 g (Carbohydrate Free Mixture)	Oral	Carbohydrate Free Mixture	Nutricia Australia Pty Limited	99 076 246 752
Mineral mixture	Oral powder 250 g (Metabolic Mineral Mixture)	Oral	Metabolic Mineral Mixture	Nutricia Australia Pty Limited	99 076 246 752

[40] Schedule 1, omit items dealing with "Minaphlex", "Monogen", "MSUD Aid III", "MSUD Analog", "MSUD Express", "MSUD Express Cooler", "MSUD Maxamaid", "MSUD Maxamum", "MSUD-Gel", "Neocate", "Neocate Advance", "Neocate Advance Tropical Flavour" and "Neocate LCP"

[41] Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone, 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

omit from the column headed “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

and substitute:

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

[42] Schedule 1, item dealing with Oestradiol and Oestradiol with Norethisterone, 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

omit from the column headed “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

and substitute:

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

[43] Schedule 1, after item dealing with Oxaliplatin, Solution concentrate for I.V. infusion 100 mg in 20 mL

insert in the columns in the order indicated:

Oxaliplatin

Solution concentrate for I.V. infusion 200 mg in 40 mL

Injection

Eloxatin

sanofi-aventis Australia Pty Ltd

31 008 558 807

[44] Schedule 1, items dealing with Pantoprazole, Tablet (enteric coated) 20 mg (as sodium sesquihydrate) and Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

omit from the column headed “Responsible Person”:

Altana Pharma Pty Ltd

and substitute:

Nycomed Pty Ltd

[45] Schedule 1, omit items dealing with "Pepti-Junior", "Phenex-2", "Phlexy-10", "Phlexy-10 Drink Mix", "PK AID II", "PKU Cooler 10", "PKU Cooler 15", "PKU Cooler 20", "PKU-Express" and "PKU-Gel"

[46] Schedule 1, item dealing with Prochlorperazine, Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5

omit from the column headed “Form”:

Suppositories 15 mg, equivalent to 25 mg prochlorperazine maleate, 5

and substitute:

Suppositories containing prochlorperazine equivalent to 25 mg prochlorperazine maleate, 5

[47] Schedule 1, items dealing with Prochlorperazine, Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5

omit from the column headed “Form”:

Suppositories 3 mg, equivalent to 5 mg prochlorperazine maleate, 5

and substitute:

Suppositories containing prochlorperazine equivalent to 5 mg prochlorperazine maleate, 5

[48] Schedule 1, omit item dealing with "Pro-Phree"

[49] Schedule 1, after item dealing with Propylthiouracil

insert in the columns in the order indicated:

Protein hydrolysate formula with medium chain triglycerides	Oral powder 400 g (Alfaré)	Oral	Alfaré	Nestle Australia Ltd	77 000 011 316
Protein hydrolysate formula with medium chain triglycerides	Oral powder 450 g (Pepti-Junior)	Oral	Pepti-Junior	Nutricia Australia Pty Limited	99 076 246 752

[50] Schedule 1, after item dealing with Ramipril, Capsule 10 mg, Tritace 10 mg

insert in the columns in the order indicated:

Ramipril

Capsule 10 mg

Oral

Tryzan 10

Alphapharm Pty Ltd

93 002 359 739

[51] Schedule 1, omit items dealing with "RCF" and "S-26 LF"

[52] Schedule 1, omit item dealing with Simvastatin, Tablet 5 mg, Lipex 5

[53] Schedule 1, omit item dealing with Sodium Alginate with Calcium Carbonate and Sodium Bicarbonate

[54] Schedule 1, item dealing with Sodium Lactate Compound

omit from the column headed “Form”:

I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as

and substitute:

I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L

[55] Schedule 1, after items dealing with Sotalol

insert in the columns in the order indicated:

Soy protein and fat formula with vitamins and minerals — carbohydrate free

Oral liquid 384 mL (RCF)

Oral

RCF

Abbott Australasia Pty Ltd

95 000 180 389

[56] Schedule 1, item dealing with Testosterone, Injection_containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in

omit from the column headed “Form”:

Injection_containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in

and substitute:

Injection containing testosterone esters (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaprate, 100 mg testosterone decanoate) in 1 mL

[57] Schedule 1, item dealing with Ticarcillin with Clavulanic Acid

omit from the column headed “Form”:

Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with required solvent)

and substitute:

Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) (with any determined brand of sodium chloride injection as the required solvent)

[58] Schedule 1, omit item dealing with Triglycerides Oil - Medium Chain

[59] Schedule 1, after items dealing with Trifluoperazine

insert in the columns in the order indicated:

Triglycerides — medium chain, formula	Oral powder 400 g (Monogen)	Oral	Monogen	Nutricia Australia Pty Limited	99 076 246 752
Triglycerides — medium chain, formula	Oral powder 420 g (Caprilon)	Oral	Caprilon	Nutricia Australia Pty Limited	99 076 246 752
Triglycerides, medium chain	Oil 500 mL (MCT Oil)	Oral	MCT Oil	Nutricia Australia Pty Limited	99 076 246 752
Triglycerides, medium chain and long chain with glucose polymer	Oral powder 400 g (Duocal)	Oral	Duocal	Nutricia Australia Pty Limited	99 076 246 752

[60] Schedule 1, omit items dealing with "TYR Express" and "TYR Gel"

[61] Schedule 1, after items dealing with Warfarin

insert in the columns in the order indicated:

Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose

Oral powder 400 g (Kindergen)

Oral

Kindergen

Nutricia Australia Pty Limited

99 076 246 752

[62] Schedule 1, omit items dealing with "XLYS, LOW TRY Analog", "XLYS, LOW TRY Maxamaid", "XMET Analog", "XMET Maxamaid", "XMET Maxamum", "XMTVI Analog", "XMTVI Asadon", "XMTVI Maxamaid", "XMTVI Maxamum", "XP Analog", "XP Analog LCP", "XP Maxamaid", "XP Maxamum", "XPhen, Tyr Analog", "XPhen, Tyr Maxamaid", "XPhen, Tyr Maxamum" and "XPTM Tyrosidon"