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: Erbitux
Active Ingredient: Cetuximab 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany
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 America
AstraZeneca UK Limited, 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, Newark, Delaware, United States of America
AstraZeneca 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 America
AstraZeneca 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 America
AstraZeneca 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 America
AstraZeneca UK Limited, Macclesfield, Cheshire, United Kingdom
Dated this 1st day of February 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).