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:
Active Ingredient: Influenza virus Haemagglutinin A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75µg
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals, Dresden, Germany
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, GSK is to provide updated evidence of the surrogate markers used
to estimate efficacy of the pandemic vaccine formulation and is committed to provide a Risk Management Plan for, or including, New Zealand.
Also Note: This consent is valid for two years from the date of publication of this notice.
Dated this 18th day of January 2012.
DR PAT TUOHY, Acting 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).