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: Nitro-Dur 10
Active Ingredient: Glyceryl trinitrate 80mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain
Product: Nitro-Dur 15
Active Ingredient: Glyceryl trinitrate 120mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain
Product: Nitro-Dur 2.5
Active Ingredient: Glyceryl trinitrate 20mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain
Product: Nitro-Dur 5
Active Ingredient: Glyceryl trinitrate 40mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain
Product: Nitro-Dur 7.5
Active Ingredient: Glyceryl trinitrate 60mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Merck Sharp & Dohme Corp, Florida, United States of America
Schering-Plough SA, Madrid, Spain
Dated this 9th day of October 2013.
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).