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: Botox
Active Ingredient: Botulinum A toxin 50U
Dosage Form: Powder for injection
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturer: Allergan Pharmaceuticals Ireland, County Mayo, Ireland
Product: Resotrans
Active Ingredient: Prucalopride succinate 1.321mg equivalent to prucalopride 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen-Cilag SpA, Latina, Italy
Product: Resotrans
Active Ingredient: Prucalopride succinate 2.642mg equivalent to prucalopride 2mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen-Cilag SpA, Latina, Italy
Dated this 19th day of April 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).