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: Aclasta
Active Ingredient: Zoledronic acid monohydrate 0.0533mg/mL equivalent to zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Botox®
Active Ingredient: Botulinum A toxin 100U
Dosage Form: Powder for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, County Mayo, Ireland
Dated this 9th day of August 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).