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: Hycamtin
Active Ingredient: Topotecan hydrochloride 1.24mg equivalent to 1.1mg topotecan free base
Dosage Form: Powder for infusion
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Corporation, Building 16A, 801 River Road, Conshohocken, Pennsylvania, United States of America
Product: Hycamtin
Active Ingredient: Topotecan hydrochloride 4.49mg/dose equivalent to 4mg topotecan
Dosage Form: Powder for infusion
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: SmithKline Beecham Corporation, Anti-infective man. operations, 801 River Road, Conshohocken, Pennsylvania, United States of America
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 1.2mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Building HAC, Hagedornsvej 1, Gentofte, Denmark
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 2.4mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Building HAC, Hagedornsvej 1, Gentofte, Denmark
Product: NovoSeven
Active Ingredient: Factor VIIa, recombinant human 4.8mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Novo Nordisk Pharmaceuticals Limited
Manufacturer: Novo Nordisk A/S, Building HAC, Hagedornsvej 1, Gentofte, Denmark
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, 587 Old Baltimore Pike, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, United Kingdom
Product: Seroquel
Active Ingredient: Quetiapine fumarate 172.69mg equivalent 150mg quetiapine
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, 587 Old Baltimore Pike, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Silk Road Business Park, 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, 587 Old Baltimore Pike, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Silk Road Business Park, 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, 587 Old Baltimore Pike, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Silk Road Business Park, 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, 587 Old Baltimore Pike, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, United Kingdom
Dated this 7th day of December 2006.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).