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: Aclasta
Active Ingredient: Zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Kogenate FS
Active Ingredient: Octocog alfa 2000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, United States of America
Product: Kogenate FS
Active Ingredient: Octocog alfa 1000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, United States of America
Dated this 25th day of September 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).