Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are 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
Product: Multihance
Active Ingredient: Gadobenate dimeglumine 0.529g/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Regional Health Limited
Manufacturers: Bracco SpA., Milano, Italy
Patheon Italia SpA, Ferentino Frosinone, Italy
Dated this 1st day of May 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).