Notice Type
Departmental
Notice Title

Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:
Schedule
Product: Pandemic Influenza Vaccine H5N1 Baxter
Active Ingredient: Influenza vaccine whole virion, vero cell derived, inactivated, H5N1 7.5µg
Dosage Form: Suspension for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter AG, Vienna, Austria
Note: This consent is given subject to the following condition:
- The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.
Note: This renewed consent is valid for two years from 5 August 2012.
Dated this 19th day of July 2012.
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).