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: Dexamethasone-hameln
Active Ingredient: Dexamethasone sodium phosphate 4.37mg equivalent to Dexamethasone phosphate 4mg
Dosage Form: Solution for injection
New Zealand Sponsor: Max Health Limited
Manufacturer: Hameln Pharmaceuticals GmbH, Hameln, Germany
Product: iQuit
Active Ingredient: Nicotine polacrilex 11.44mg equivalent to Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Watson Laboratories Inc, New York, United States of America
Product: iQuit
Active Ingredient: Nicotine polacrilex 22.89mg equivalent to Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Watson Laboratories Inc, New York, United States of America
Product: Lumigan PF
Active Ingredient: Bimatoprost 0.3mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturers: Allergan Pharmaceuticals Ireland, County Mayo, Ireland
Allergan Sales LLC, Texas, United States of America
Product: Picato
Active Ingredient: Ingenol mebutate 0.015%w/w
Dosage Form: Topical gel
New Zealand Sponsor: LEO Pharma Limited
Manufacturers: LEO Laboratories Limited, Dublin, Ireland
DPT Laboratories Limited, Texas, United States of America
Product: Picato
Active Ingredient: Ingenol mebutate 0.05%w/w
Dosage Form: Topical gel
New Zealand Sponsor: LEO Pharma Limited
Manufacturers: LEO Laboratories Limited, Dublin, Ireland
DPT Laboratories Limited, Texas, United States of America
Dated this 16th day of October 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).