Download F2007L03613 F2007L03613

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.
1
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
[3]
Oral
Oral liquid
containing alginic
acid as sodium
alginate 1 g,
calcium carbonate
320 mg and sodium
bicarbonate 534 mg
in 20 mL, 500 mL
Gaviscon P
Reckitt Benckiser 17 003 274 655
(Australia) Pty
Limited
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
Oral powder 400 g
lysine and low in
(XLYS, LOW TRY
tryptophan
Analog)
Oral
XLYS, LOW
TRY Analog
2
Nutricia Australia
Pty Limited
99 076 246 752
Amino acid formula
with vitamins and
minerals without
lysine and low in
tryptophan
Amino acid formula
with vitamins and
minerals without
methionine
Amino acid formula
with vitamins and
minerals without
methionine
Amino acid formula
with vitamins and
minerals without
methionine
Amino acid formula
with vitamins and
minerals without
methionine
Amino acid formula
with vitamins and
minerals without
methionine
Amino acid formula
with vitamins and
minerals without
methionine,
threonine and valine
and low in
isoleucine
Amino acid formula
with vitamins and
minerals without
methionine,
threonine and valine
and low in
isoleucine
Amino acid formula
with vitamins and
minerals without
methionine,
threonine and valine
and low in
isoleucine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Oral powder 500 g
(XLYS, LOW TRY
Maxamaid)
Oral
XLYS, LOW
Nutricia Australia
TRY Maxamaid Pty Limited
99 076 246 752
Oral powder 400 g
(XMET Analog)
Oral
XMET Analog
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(XMET Maxamaid) Oral
XMET
Maxamaid
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(XMET Maxamum) Oral
XMET
Maxamum
Nutricia Australia
Pty Limited
99 076 246 752
Sachets containing
oral powder 20 g,
30 (HCU gel)
Oral
HCU gel
Vitaflo Australia
Pty Ltd
82 097 161 254
Sachets containing
oral powder 25 g,
30 (HCU express)
Oral
HCU express
Vitaflo Australia
Pty Ltd
82 097 161 254
Oral powder 400 g
(XMTVI Analog) Oral
Nutricia Australia
XMTVI Analog Pty Limited
99 076 246 752
Oral powder 500 g
(XMTVI
Maxamaid)
Oral
XMTVI
Maxamaid
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(XMTVI
Maxamum)
Oral
XMTVI
Maxamum
Nutricia Australia
Pty Limited
99 076 246 752
Oral liquid 125 mL,
30 (Lophlex LQ)
Oral
Lophlex LQ
Nutricia Australia
Pty Limited
99 076 246 752
Oral liquid 130 mL,
30 (PKU Cooler 15) Oral
Vitaflo Australia
PKU Cooler 15 Pty Ltd
82 097 161 254
Oral liquid 174 mL,
30 (PKU Cooler 20) Oral
Vitaflo Australia
PKU Cooler 20 Pty Ltd
82 097 161 254
3
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine
Amino acid formula
with vitamins and
minerals without
phenylalanine and
tyrosine
Amino acid formula
with vitamins and
minerals without
phenylalanine and
tyrosine
Oral liquid 250 mL
(Easiphen)
Oral
Easiphen
Nutricia Australia
Pty Limited
99 076 246 752
Oral liquid 87 mL,
30 (PKU Cooler 10) Oral
Vitaflo Australia
PKU Cooler 10 Pty Ltd
82 097 161 254
Phenex-2
Abbott
Australasia Pty
Ltd
95 000 180 389
Oral powder 400 g
(Phenex-2)
Oral
Phenex-2
Abbott
Australasia Pty
Ltd
95 000 180 389
Oral powder 400 g
(XP Analog)
Oral
XP Analog
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(XP Maxamaid)
Oral
XP Maxamaid
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(XP Maxamum)
Oral
XP Maxamum
Nutricia Australia
Pty Limited
99 076 246 752
Sachets containing
oral powder 20 g,
30 (PKU-gel)
Oral
PKU-gel
Vitaflo Australia
Pty Ltd
82 097 161 254
Sachets containing
oral powder 25 g,
30 (PKU-Express)
Oral
PKU-Express
Vitaflo Australia
Pty Ltd
82 097 161 254
Sachets containing
oral powder 27.8 g,
30 (Lophlex)
Oral
Lophlex
Nutricia Australia
Pty Limited
99 076 246 752
Sachets containing
oral powder 29 g,
30 (Minaphlex)
Minaphlex
Nutricia Australia
Pty Limited
99 076 246 752
Sachets containing
oral powder 50 g,
30 (XP Maxamum) Oral
XP Maxamum
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 400 g
(XPhen, Tyr
Analog)
Oral
XPhen, Tyr
Analog
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(XPhen, Tyr
Maxamaid)
Oral
XPhen, Tyr
Maxamaid
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 325 g
(Phenex-2)
Oral
Oral
4
Amino acid formula
with vitamins and
minerals without
phenylalanine and
tyrosine
Amino acid formula
with vitamins and
minerals without
phenylalanine and
tyrosine
Amino acid formula
with vitamins and
minerals without
phenylalanine and
tyrosine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Oral powder 500 g
(XPhen, Tyr
Maxamum)
Oral
XPhen, Tyr
Maxamum
Nutricia Australia
Pty Limited
99 076 246 752
Sachets containing
oral powder 20 g,
30 (TYR gel)
Oral
TYR gel
Vitaflo Australia
Pty Ltd
82 097 161 254
Sachets containing
oral powder 25 g,
30 (TYR Express)
Oral
TYR Express
Vitaflo Australia
Pty Ltd
82 097 161 254
MSUD Express Vitaflo Australia
Cooler
Pty Ltd
82 097 161 254
Oral liquid 130 mL,
30 (MSUD Express
Cooler)
Oral
Ketonex-2
Abbott
Australasia Pty
Ltd
95 000 180 389
Oral powder 350 g
(Ketonex-1)
Oral
Ketonex-1
Abbott
Australasia Pty
Ltd
95 000 180 389
Oral powder 400 g
(MSUD Analog)
Oral
Nutricia Australia
MSUD Analog Pty Limited
99 076 246 752
Oral powder 500 g
(MSUD AID III)
Oral
Nutricia Australia
MSUD AID III Pty Limited
99 076 246 752
Oral powder 500 g
(MSUD Maxamaid) Oral
MSUD
Maxamaid
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 500 g
(MSUD Maxamum) Oral
MSUD
Maxamum
Nutricia Australia
Pty Limited
99 076 246 752
Sachets containing
oral powder 20 g,
30 (MSUD-gel)
MSUD-gel
Vitaflo Australia
Pty Ltd
82 097 161 254
Vitaflo Australia
MSUD Express Pty Ltd
82 097 161 254
Oral powder 325 g
(Ketonex-2)
Oral
Oral
Sachets containing
oral powder 25 g,
30 (MSUD Express) Oral
5
Amino acid formula
with vitamins and
minerals without
valine, leucine and
isoleucine
Amino acid formula
with vitamins,
minerals and long
chain
polyunsaturated
fatty acids without
phenylalanine
Amino acid formula
without methionine,
threonine and valine
and low in
isoleucine
Amino acid formula
without
phenylalanine
Amino acid formula
without
phenylalanine
Amino acid formula
without
phenylalanine
Sachets containing
oral powder 29 g,
30 (Mapleflex)
Oral
Mapleflex
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 400 g
(XP Analog LCP) Oral
Nutricia Australia
XP Analog LCP Pty Limited
99 076 246 752
Oral powder 200 g
(XMTVI Asadon) Oral
Nutricia Australia
XMTVI Asadon Pty Limited
99 076 246 752
Bars 42 g, 20
(Phlexy-10)
Oral
Phlexy-10
Nutricia Australia
Pty Limited
99 076 246 752
Capsules 500 mg,
200 (Phlexy-10)
Oral
Phlexy-10
Nutricia Australia
Pty Limited
99 076 246 752
PK AID II
Nutricia Australia
Pty Limited
99 076 246 752
Oral powder 250 g
(PK AID II)
Oral
Sachets containing
Amino acid formula oral powder 20 g,
without
30 (Phlexy-10
phenylalanine
Drink Mix)
Oral
Amino acid formula
without
Tablets 1 g, 75
phenylalanine
(Phlexy-10)
Oral
Amino acid formula
without
phenylalanine,
tyrosine and
Oral powder 500 g
methionine
(XPTM Tyrosidon) Oral
Amino acid
synthetic formula
supplemented with
long chain
polyunsaturated
Oral powder 400 g
fatty acids
(Neocate LCP)
Oral
Amino acids —
synthetic, formula
Oral powder 400 g
(EleCare)
Oral
Amino acids —
synthetic, formula
Amino acids —
synthetic, formula
Amino acids —
synthetic, formula
Oral powder 400 g
(Neocate Advance
Tropical Flavour) Oral
Oral powder 400 g
(Neocate Advance) Oral
Oral powder 400 g
(Neocate)
Oral
Phlexy-10 Drink Nutricia Australia
Mix
Pty Limited
99 076 246 752
Phlexy-10
Nutricia Australia
Pty Limited
99 076 246 752
XPTM
Tyrosidon
Nutricia Australia
Pty Limited
99 076 246 752
Neocate LCP
EleCare
Neocate
Advance
Tropical
Flavour
Neocate
Advance
Neocate
6
Nutricia Australia
Pty Limited
99 076 246 752
Abbott
Australasia Pty
Ltd
95 000 180 389
Nutricia Australia
Pty Limited
99 076 246 752
Nutricia Australia
Pty Limited
99 076 246 752
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
[7]
Tablet 100 mg
Oral
Amisulpride
Sandoz
sanofi-aventis
31 008 558 807
Australia Pty Ltd
Schedule 1, after item dealing with Amisulpride, Tablet 200 mg,
Amisulpride 200 Winthrop
insert in the columns in the order indicated:
Amisulpride
[8]
Tablet 200 mg
Oral
Amisulpride
Sandoz
sanofi-aventis
31 008 558 807
Australia Pty Ltd
Schedule 1, after item dealing with Amisulpride, Tablet 400 mg,
Amisulpride 400 Winthrop
insert in the columns in the order indicated:
Amisulpride
[9]
Tablet 400 mg
Oral
Amisulpride
Sandoz
sanofi-aventis
31 008 558 807
Australia Pty Ltd
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
Carbohydrate, fat,
vitamins, minerals
and trace elements
[12]
Oral powder 400 g Oral
(Energivit)
Energivit
Nutricia Australia 99 076 246 752
Pty Limited
Oral powder 400 g Oral
(Pro-Phree)
Pro-Phree
Abbott
Australasia Pty
Ltd
95 000 180 389
Schedule 1, omit item dealing with "Carbohydrate Free Mixture"
7
[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)
8
[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
[21]
Injection 0.5 mL
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"
9
[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
Oral powder 200 g Oral
acids formula with (Dialamine)
minerals and
vitamin C
[27]
Dialamine
Nutricia Australia 99 076 246 752
Pty Limited
Schedule 1, after item dealing with Fluconazole, Capsule 100 mg,
Fluconazole Hexal
insert in the columns in the order indicated:
Fluconazole
[28]
Capsule 100 mg
Oral
Fluconazole
Winthrop
Sandoz Pty Ltd
60 075 449 553
Schedule 1, after item dealing with Fluconazole, Capsule 200 mg,
Fluconazole Hexal
insert in the columns in the order indicated:
Fluconazole
[29]
Capsule 200 mg
Oral
Fluconazole
Winthrop
Sandoz Pty Ltd
60 075 449 553
Schedule 1, after item dealing with Folic Acid, Tablet 500 micrograms
insert in the columns in the order indicated:
Folinic acid
Injection containing Injection
calcium folinate
equivalent to
100 mg folinic
acid in 10 mL
Calcium
InterPharma Pty
Folinate Ebewe Ltd
Folinic acid
Injection containing Injection
calcium folinate
equivalent to
100 mg folinic
acid in 10 mL
Leucovorin
Calcium
10
19 099 877 899
Pfizer Pty Limited 50 008 422 348
Folinic acid
Injection containing Injection
calcium folinate
equivalent to
300 mg folinic
acid in 30 mL
Leucovorin
Calcium
Mayne Pharma
Pty Ltd
58 097 064 330
Folinic acid
Injection containing Injection
calcium folinate
equivalent to
50 mg folinic acid
in 5 mL
Calcium
InterPharma Pty
Folinate Ebewe Ltd
19 099 877 899
Folinic acid
Injection containing Injection
calcium folinate
equivalent to
50 mg folinic acid
in 5 mL
Leucovorin
Calcium
Mayne Pharma
Pty Ltd
58 097 064 330
Folinic acid
Injection containing Injection
calcium folinate
equivalent to
50 mg folinic acid
in 5 mL
Leucovorin
Calcium
Pfizer Pty Limited 50 008 422 348
Folinic acid
Tablet containing
Oral
calcium folinate
equivalent to
15 mg folinic acid
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
11
[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
Tablet 300 mgHydrochlorothiazide 25 mg
Oral
Avapro HCT
300/25
Bristol-Myers
Squibb Australia
Pty Ltd
33 004 333 322
Irbesartan with
Tablet 300 mgHydrochlorothiazide 25 mg
Oral
Karvezide
300/25
sanofi-aventis
31 008 558 807
Australia Pty Ltd
[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
release), 15 tablets metoprolol succinate 47.5 mg
release) and 15 tablets metoprolol
and substitute:
Pack containing 15 tablets metoprolol succinate 23.75 mg
release), 15 tablets metoprolol succinate 47.5 mg
release) and 15 tablets metoprolol succinate 95 mg
release)
[39]
(controlled
(controlled
(controlled
(controlled
(controlled
Schedule 1, after items dealing with Miconazole
insert in the columns in the order indicated:
Milk powder —
lactose free
formula
Oral powder 900 g Oral
(Karicare De-Lact)
Karicare DeLact
Nutricia Australia 99 076 246 752
Pty Limited
Milk powder —
lactose free
formula
Oral powder 900 g Oral
(S-26 LF)
S-26 LF
Wyeth Australia
Pty Limited
Milk powder —
lactose modified
Oral powder 900 g Oral
(Digestelact)
Digestelact
Milk powder —
synthetic
Low calcium oral
powder 400 g
(Locasol)
Locasol
Sharpe
55 001 334 854
Laboratories Pty
Ltd
Nutricia Australia 99 076 246 752
Pty Limited
Oral
16 000 296 211
Milk protein and fat Oral powder 225 g Oral
formula with
(Carbohydrate
vitamins and
Free Mixture)
minerals —
carbohydrate free
Carbohydrate
Free Mixture
Mineral mixture
Metabolic
Nutricia Australia 99 076 246 752
Mineral Mixture Pty Limited
Oral powder 250 g Oral
(Metabolic
Mineral Mixture)
12
Nutricia Australia 99 076 246 752
Pty Limited
[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
13
sanofi-aventis
31 008 558 807
Australia Pty Ltd
[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 Oral powder 400 g Oral
formula with
(Alfaré)
medium chain
triglycerides
Alfaré
Nestle Australia
Ltd
Protein hydrolysate Oral powder 450 g Oral
formula with
(Pepti-Junior)
medium chain
triglycerides
Pepti-Junior
Nutricia Australia 99 076 246 752
Pty Limited
[50]
77 000 011 316
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
14
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
[56]
Oral liquid 384 mL Oral
(RCF)
RCF
Abbott
Australasia Pty
Ltd
95 000 180 389
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
15
[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 Oral
(Monogen)
Monogen
Nutricia Australia 99 076 246 752
Pty Limited
Triglycerides —
medium chain,
formula
Oral powder 420 g Oral
(Caprilon)
Caprilon
Nutricia Australia 99 076 246 752
Pty Limited
Triglycerides,
medium chain
Oil 500 mL (MCT
Oil)
MCT Oil
Nutricia Australia 99 076 246 752
Pty Limited
Duocal
Nutricia Australia 99 076 246 752
Pty Limited
Oral
Triglycerides,
Oral powder 400 g Oral
medium chain and (Duocal)
long chain with
glucose polymer
[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
Oral powder 400 g Oral
formula
(Kindergen)
supplemented with
amino acids,
vitamins and
minerals, and low
in protein,
phosphate,
potassium and
lactose
Kindergen
Nutricia Australia 99 076 246 752
Pty Limited
[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"
16