Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Prevenar 13
Active Ingredients: 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
Dosage Form: Suspension for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Wyeth Pharmaceuticals Inc, New York, United States of America
Baxter BioPharma Solutions LLC, Indiana, United States of America
Product: Zevalin
Active Ingredient: Ibritumomab tiuxetan 1.6mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Dated this 5th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).