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: Arrow - Pantop
Active Ingredient: Pantoprazole sodium sesquihydrate 22.556mg equivalent to Pantoprazole base 20mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Goa, India
Product: Fresofol 1% MCT/LCT
Active Ingredient: Propofol 10mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturer: Fresenius Kabi Austria GmbH, Graz, Austria
Product: Pantoprazole Actavis 20
Active Ingredient: Pantoprazole sodium sesquihydrate 22.58mg equivalent to Pantoprazole 20mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Actavis hf., Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Product: Pantoprazole Actavis 40
Active Ingredient: Pantoprazole sodium sesquihydrate 45.16mg equivalent to pantoprazole 40mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturers: Actavis hf., Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta
Dated this 23rd day of May 2013.
DR JOHN CRAWSHAW, Acting 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).