Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:
Schedule
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Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
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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
GlaxoSmithKline Biologicals SA, Wavre, Belgium
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Note: This consent is given subject to the following conditions:
- 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.
- 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 renewed consent is valid for two years from 31 July 2018.
Dated this 29th day of June 2018.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).