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 medicines set out in the Schedule hereto:
Schedule
Product: Arava
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Hoechst Marion Roussel, Usiphar Production Unit, Compeigne, France
Note: This consent is valid for 2 years from 23 March 2002.
Product: Arava
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Hoechst Marion Roussel, Usiphar Production Unit, Compeigne, France
Note: This consent is valid for 2 years from 23 March 2002.
Product: Arava
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Aventis Pharma Limited
Manufacturer: Hoechst Marion Roussel, Usiphar Production Unit, Compeigne, France
Note: This consent is valid for 2 years from 23 March 2002.
Product: Gutron
Active Ingredient: Midodrine hydrochloride 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Nycomed Austria GmbH, Linz, Austria
Note: This consent is valid for 2 years from 30 April 2002.
Product: Gutron
Active Ingredient: Midodrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Nycomed Austria GmbH, Linz, Austria
Note: This consent is valid for 2 years from 30 April 2002.
Dated this 13th day of March 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).