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: Arrow - Iloprost
Active Ingredient: Iloprost 0.1mg/mL equivalent to Iloprost trometamol 0.134mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: IBN Savio Srl, Genoa, Italy
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
Baxter BioPharma Solutions LLC, Indiana, United States of America
Wyeth Pharmaceuticals Inc, New York, United States of America
Dated this 29th day of August 2014.
STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).