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: Afinitor
Active Ingredient: Everolimus 2.5mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma AG, Basel, Switzerland
Novartis Pharma AG, Stein, Switzerland
Product: Apo-Montelukast
Active Ingredient: Montelukast sodium 4.16mg equivalent to montelukast 4mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Apo-Montelukast
Active Ingredient: Montelukast sodium 5.2mg equivalent to montelukast 5mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Research Private Limited, Bangalore, India
Product: Artelac NighttimeGel
Active Ingredient: Carbomer 2mg/g
Dosage Form: Ophthalmic gel
New Zealand Sponsor: Bausch & Lomb (NZ) Limited
Manufacturer: Dr Gerhard Mann Chem-Pharm Fabrik GmbH, Berlin, Germany
Product: Eviplera
Active Ingredients: Emtricitabine 200mg
Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine free base 25mg
Tenofovir disoproxil fumarate 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Gilead Sciences (NZ)
Manufacturer: Patheon Inc, Ontario, Canada
Dated this 27th day of June 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).