Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto.
Schedule
Product: Plavix
Active Ingredient(s): Clopidogrel hydrogen sulfate 97.875mg equivalent to 75 mg free base
Dosage Form: Film coated tablet
New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited
Manufacturer(s): Sanofi Winthrop Industrie, Ambares, France
Sanofi Winthrop Limited, Production Division, Fawdon, Newcastle-upon-Tyne, United Kingdom
Dated this 8th day of August 2001.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).