Notice Type
Departmental
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:
Schedule
Product: Arava
Active Ingredient(s): Leflunomide 10mg
Dosage Form: Film coated tablet
NZ Sponsor: Aventis Pharma Limited
Manufacturer(s): Hoechst Marion Roussel, Usiphar Production Unit, Compeigne, France
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Arava
Active Ingredient(s): Leflunomide 100mg
Dosage Form: Film coated tablet
NZ Sponsor: Aventis Pharma Limited
Manufacturer(s): Hoechst Marion Roussel, Usiphar Production Unit, Compeigne, France
Note: This consent is valid for 2 years from the date of publication of this notice.
Product: Arava
Active Ingredient(s): Leflunomide 20mg
Dosage Form: Film coated tablet
NZ Sponsor: Aventis Pharma Limited
Manufacturer(s): Hoechst Marion Roussel, Usiphar Production Unit, Compeigne, France
Note: This consent is valid for 2 years from the date of publication of this notice.
Dated this 20th day of March 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.