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: Glivec
Active Ingredient: Imatinib mesilate 59.75mg equivalent to Imatinib base 50mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to Imatinib base 100mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 119.5mg equivalent to Imatinib base 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Glivec
Active Ingredient: Imatinib mesilate 478mg equivalent to Imatinib base 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Prevenar 13
Active Ingredients: Pneumococcal polysaccharide serotype 6A 2.2µg
Pneumococcal Polysaccharide type 1 2.2µg
Pneumococcal Polysaccharide type 14 2.2µg
Pneumococcal Polysaccharide type 18C 2.2µg
Pneumococcal Polysaccharide type 19A 2.2µg
Pneumococcal Polysaccharide type 19F 2.2µg
Pneumococcal Polysaccharide type 23F 2.2µg
Pneumococcal Polysaccharide type 3 2.2µg
Pneumococcal Polysaccharide type 4 2.2µg
Pneumococcal Polysaccharide type 5 2.2µg
Pneumococcal Polysaccharide type 6B 4.4µg
Pneumococcal Polysaccharide type 7F 2.2µg
Pneumococcal Polysaccharide type 9V 2.2µg
Dosage Form: Suspension for injection
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturers: Wyeth Pharmaceuticals Inc, New York, United States of America
Baxter BioPharma Solutions LLC, Indiana, United States of America
Dated this 23rd day of May 2012.
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).