Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Kabiven Peripheral
Glucose Component:
Active Ingredient: Glucose monohydrate 12.1% equivalent to 11% glucose anhydrous
Dosage Form: Solution for injection
Vamin 18 Novum Component:
Active Ingredients: Alanine 1.6% Arginine 1.13% Aspartic acid 0.34% Calcium chloride dihydrate 0.074% Glutamic acid 0.56% Glycine 0.79% Histidine 0.68% Isoleucine 0.56% Leucine 0.79% Lysine hydrochloride 0.9% Magnesium sulphate 0.16% Methionine 0.56% Phenylalanine 0.79% Potassium chloride 0.597% Proline 0.68% Serine 0.45% Sodium acetate trihydrate 0.49% Sodium glycerophosphate 0.54% Threonine 0.56% Tryptophan 0.19% Tyrosine 0.023% Valine 0.73%
Dosage Form: Solution for injection
Intralipid Component:
Active Ingredient: Soya oil 20%
Dosage Form: Emulsion for injection
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Product: Kabiven
Glucose Component:
Active Ingredient: Glucose monohydrate 20.9% equivalent to 19% glucose anhydrous
Dosage Form: Solution for injection
Vamin 18 Novum Component:
Active Ingredients: Alanine 1.6% Arginine 1.13%Aspartic acid 0.34% Calcium chloride dihydrate 0.074% Glutamic acid 0.56% Glycine 0.79% Histidine 0.68% Isoleucine 0.56% Leucine 0.79% Lysine hydrochloride 0.9% Magnesium sulphate 0.16% Methionine 0.56% Phenylalanine 0.79% Potassium chloride 0.597% Proline 0.68% Serine 0.45% Sodium acetate trihydrate 0.49% Sodium glycerophosphate 0.54% Threonine 0.56% Tryptophan 0.19% Tyrosine 0.023% Valine 0.73%
Dosage Form: Solution for injection
Intralipid Component:
Active Ingredient: Soya oil 20%
Dosage Form: Emulsion for injection
New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited
Manufacturer: Fresenius Kabi AB, Uppsala, Sweden
Product: Pegasys
Active Ingredient: Peginterferon alfa-2a 270Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Pegasys
Active Ingredients: Peginterferon alfa-2a 360Ág/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Seroquel
Active Ingredient: Quetiapine fumarate 115.13mg equivalent to 100mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of AmericaAstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Seroquel
Active Ingredient: Quetiapine fumarate 172.69mg equivalent to 150mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of AmericaAstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Seroquel
Active Ingredient: Quetiapine fumarate 230.26mg equivalent to 200mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of AmericaAstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Seroquel
Active Ingredient: Quetiapine fumarate 28.78mg equivalent to 25mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of AmericaAstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Seroquel
Active Ingredient: Quetiapine fumarate 345.39mg equivalent to 300mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of AmericaAstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Product: Valcyte
Active Ingredient: Valganciclovir hydrochloride 496.3mg equivalent to 450mg valganciclovir
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer: Patheon Inc, Mississauga, Ontario, Canada
Dated this 1st day of August 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).