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 set out in the Schedule hereto:
Schedule
Product: Acarbocin
Active Ingredient: Acarbose 50mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Famar Italia SpA, Milano, Italy
Product: Acarbocin
Active Ingredient: Acarbose 100mg
Dosage Form: Tablet
New Zealand Sponsor: Boucher & Muir (New Zealand) Limited t/a BNM Group
Manufacturer: Famar Italia SpA, Milano, Italy
Product: YAZ Flex
Active Ingredients: Drospirenone 3mg
Ethinylestradiol 20mcg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Weimar GmbH und Co KG, Weimar, Germany
Product: Zinforo
Active Ingredient: Ceftaroline fosamil 600mg equivalent to ceftaroline fosamil acetic acid solvate monohydrate 668.4mg
Dosage Form: Powder for injection
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: Facta Farmaceutica SpA, Teramo, Italy
Dated this 21st day of August 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).