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: Broncolin
Active Ingredient: Salbutamol sulfate 0.482mg/mL equivalent to Salbutamol 0.4mg/mL
Dosage Form: Syrup
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Tipperary, Ireland
Product: Prothrombinex-VF
Active Ingredients: Factor II 500IU
Factor IX 500IU
Factor X 500IU
Dosage Form: Powder for injection with diluent
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Melbourne, Australia
Dated this 16th 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).