Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution 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: Synflorix
Active Ingredients: Pneumococcal Polysaccharide type 1 1µg
Pneumococcal Polysaccharide type 14 1µg
Pneumococcal Polysaccharide type 18C 3µg
Pneumococcal Polysaccharide type 19F 3µg
Pneumococcal Polysaccharide type 23F 1µg
Pneumococcal Polysaccharide type 4 3µg
Pneumococcal Polysaccharide type 5 1µg
Pneumococcal Polysaccharide type 6B 1µg
Pneumococcal Polysaccharide type 7F 1µg
Pneumococcal Polysaccharide type 9V 1µg
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals SA, Wavre, Belgium
Dated this 7th day of April 2011.
MARK JACOBS, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).