Notice Type
Notice Title

Provisional Consent to the Distribution of a New Medicine

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:
Product: Modavigil
Active Ingredient(s): Modafinil 100mg
Dosage Form: Tablet
New Zealand Sponsor: CSL (New Zealand) Limited
Manufacturer(s): Laboratoires Macors, de la Plaine des Isles, Auxerre, France
Laboratoires Opodex Industrie, Villeneuve la Garenne, (Hauts-de-Seine), France
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 10th 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).