Pursuant to section 23(1) 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: Pandemic Influenza Vaccine H5N1 Baxter
Active Ingredient: Influenza vaccine whole virion, vero cell derived, inactivated 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 product may only be marketed or distributed in accordance with the directives contained in the current version of the National Health Emergency Plan.
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 30th day of July 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).