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 set out in the Schedule hereto:
Schedule
Product: Ephedrine Hydrochloride Injection
Active Ingredient: Ephedrine hydrochloride 30mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Martindale Pharmaceuticals, Romford, United Kingdom
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
Product: Rapamune
Active Ingredient: Sirolimus 1mg
Dosage Form: Coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Wyeth Pharmaceutical Company, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, New York, United States of America
Product: Rapamune
Active Ingredient: Sirolimus 2mg
Dosage Form: Coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Wyeth Pharmaceutical Company, Guayama, Puerto Rico
Wyeth Pharmaceuticals Inc, New York, United States of America
Product: Rapamune
Active Ingredient: Sirolimus 0.5mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Wyeth Pharmaceutical Company, Guayama, Puerto Rico
Product: Winglore
Active Ingredient: Ipilimumab 53.5mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Winglore
Active Ingredient: Ipilimumab 213mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Yervoy
Active Ingredient: Ipilimumab 213mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Yervoy
Active Ingredient: Ipilimumab 53.5mg
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Dated this 14th day of March 2012.
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).