Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the 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: Dotarem (bottle)
Active Ingredient: Gadoteric acid 279.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Obex Medical Limited
Manufacturers: Guerbet, Aulnay Sous Bois, France
Catalent Belgium SA, Brussels, Belgium
Product: Dotarem (syringe)
Active Ingredient: Gadoteric acid 279.32mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Obex Medical Limited
Manufacturers: Guerbet, Aulnay Sous Bois, France
Rovi Contract Manufacturing SL, Madrid, Spain
Catalent Belgium SA, Brussels, Belgium
Product: Menomune ACYW-135 vaccine
Active Ingredients: Neisseria meningitidis, Group A 50µg
Neisseria meningitidis, Group C 50µg
Neisseria meningitidis, Group W135 50µg
Neisseria meningitidis, Group Y 50µg
Dosage Form: Powder for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Inc, Pennsylvania, United States of America
Dated this 15th day of September 2011.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).