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: Afinitor
Active Ingredient: Everolimus 5mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland
Product: Afinitor
Active Ingredient: Everolimus 10mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland
Dated this 24th day of April 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).