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:
Active Ingredients:
Dosage Form:
New Zealand Sponsor:
Manufacturers:
|
Prevenar 13
Pneumococcal polysaccharide serotype 6A 2.2mcg
Pneumococcal polysaccharide type 1 2.2mcg
Pneumococcal polysaccharide type 14 2.2mcg
Pneumococcal polysaccharide type 18C 2.2mcg
Pneumococcal polysaccharide type 19A 2.2mcg
Pneumococcal polysaccharide type 19F 2.2mcg
Pneumococcal polysaccharide type 23F 2.2mcg
Pneumococcal polysaccharide type 3 2.2mcg
Pneumococcal polysaccharide type 4 2.2mcg
Pneumococcal polysaccharide type 5 2.2mcg
Pneumococcal polysaccharide type 6B 4.4mcg
Pneumococcal polysaccharide type 7F 2.2mcg
Pneumococcal polysaccharide type 9V 2.2mcg
Suspension for injection
Pfizer New Zealand Limited
Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, New York, United States of America
Baxter BioPharma Solutions LLC, Indiana, United States of America
|
Dated this 17th day of September 2015.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).
Gazette.govt.nz