Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Modavigil
Active Ingredient: Modafinil 100mg
Dosage Form: Tablet
New Zealand Sponsor: CSL New Zealand Limited
Manufacturers: Laboratoires Macors, Auxerre, France
Laboratoires Opodex Industrie, Villeneuve la Garenne, (Hauts-de-Seine), France
Note: This consent is valid for two years from 16 August 2003.
Dated this 9th day of May 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).