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: Babi Pregnancy Test
Active Ingredients: Anti-alpha HCG monoclonal antibody 0.76µg - 0.91µg
Anti-beta HCG monoclonal antibody 0.6µg
Goat anti-mouse polyclonal antibody 1.14µg - 1.52µg
Dosage Form: Pregnancy test kit
New Zealand Sponsor: Blue Cross New Zealand Limited
Manufacturer: Blue Cross Bio-Medical (Beijing) Co Limited, Beijing, China
Product: Oxycodone Orion
Active Ingredient: Oxycodone hydrochloride 10mg
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Orion Corporation, Espoo, Finland
Product: Saphris
Active Ingredient: Asenapine maleate 7.03mg equivalent to asenapine 5mg
Dosage Form: Wafer
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Wiltshire, United Kingdom
Product: Saphris
Active Ingredient: Asenapine maleate 14.06mg equivalent asenapine 10mg
Dosage Form: Wafer
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Catalent UK Swindon Zydis Limited, Wiltshire, United Kingdom
Dated this 22nd day of March 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).