Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Rapamune
Active Ingredient: Sirolimus 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Wyeth Pharmaceuticals Inc, New York, United States of America
Patheon Inc, Ontario, Canada
Note: This consent is valid for two years from the date of publication of this notice.
Product: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Wyeth Pharmaceutical Company, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, New York, United States of America
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 5th day of December 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).