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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 which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Pandemrix
Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Note: This consent is given subject to the following conditions:

  1. 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.
  2. In an officially 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.

Note: This consent is valid to 31 July 2018.

Dated this 6th day of January 2017.

DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).