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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 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 valid to 31 July 2016.

Dated this 20th day of March 2015.

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