Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of a New Medicine

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: Vepacel
Active Ingredient: Influenza vaccine whole virion, vero cell derived, inactivated 7.5mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturers: Baxter AG, Lange Allee 24, Vienna, Austria
Baxter AG, Lange Allee 51, 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 consent is valid for two years from the date of publication of this notice.
Dated this 18th day of July 2013.
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).