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: Sinemet
Active Ingredients: Carbidopa monohydrate 27mg equivalent to Carbidopa 25mg
Levodopa 100mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Sinemet
Active Ingredients: Carbidopa monohydrate 27mg equivalent to Carbidopa 25mg
Levodopa 250mg
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Sinemet CR
Active Ingredients: Carbidopa monohydrate 54mg equivalent to Carbidopa 50mg
Levodopa 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Dated this 19th day of July 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).