Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new 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: Cancidas
Active Ingredient: Caspofungin acetate 60.6mg equivalent to 50mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, West Point, Pennsylvania, United States of America
OSO BioPharmaceuticals Manufacturing, LLC, Albuquerque, New Mexico, United States of America
Product: Cancidas
Active Ingredient: Caspofungin acetate 83.9mg equivalent to 70mg caspofungin anhydrous free base
Dosage Form: Powder for infusion
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck & Co Inc, West Point, Pennsylvania, United States of America
OSO BioPharmaceuticals Manufacturing, LLC, Albuquerque, New Mexico, United States of America
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 57.56mg equivalent quetiapine free base 50mg
Dosage Form: Modified release 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 XR
Active Ingredient: Quetiapine fumarate 230.26mg equivalent to quetiapine free base 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Macclesfield, Cheshire, United Kingdom
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 345.38mg equivalent to quetiapine free base 300mg
Dosage Form: Modified release 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 XR
Active Ingredient: Quetiapine fumarate 460.5mg equivalent to quetiapine free base 400mg
Dosage Form: Modified release 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 4th day of December 2009.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).