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: Lucentis
Active Ingredient: Ranibizumab 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Xolair
Active Ingredient: Omalizumab 150mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Genentech Inc, California, United States of America
Product: Xolair
Active Ingredient: Omalizumab 75mg
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Genentech Inc, California, United States of America
Dated this 8th 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).