Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 22 November 2007.
Product: Rapamune
Active Ingredient: Sirolimus 2mg
Dosage Form: Coated tablet
New Zealand Sponsor: Wyeth (NZ) Limited
Manufacturers: Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, Rouses Point, New York, United States of America
Note: This consent is valid for two years from 12 January 2008.
Dated this 23rd day of November 2007.
JULIE PATTERSON, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).