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: Copaxone
Active Ingredient: Glatiramer acetate 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Teva Pharmaceutical Industries Limited, (Ikapharm), Kfar Saba, Israel
Note: This consent is valid for two years from 13 October 2007.
Product: Copaxone
Active Ingredient: Glatiramer acetate 20mg
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Teva Pharmaceutical Industries Limited, (Ikapharm), Kfar Saba, Israel
Note: This consent is valid for two years from 24 May 2007.
Dated this 31st day of May 2007.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).