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: Panvax vaccine
Active Ingredient: Influenza Virus Type A haemagglutinin 30µg
Dosage Form: Suspension for injection
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Parkville, Australia
Note: This consent is given subject to the following conditions:
- The vaccine may only be marketed, distributed or supplied in accordance with the directives contained in the New Zealand National Health Emergency Plan: New Zealand Influenza Pandemic Action Plan.
- In an official declared influenza pandemic situation, CSL is to provide updated evidence of the surrogate markers used
to estimate efficacy of the pandemic vaccine formulation and is committed to provide PSURs as outlined in the Risk Management Plan.
Also Note: This consent is valid for two years from the date of publication of this notice.
Dated this 10th day of January 2011.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).