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: Kalydeco
Active Ingredient: Ivacaftor 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novotech (New Zealand) Limited
Manufacturer: Patheon Pharmaceuticals Inc, Ohio, United States of America
Product: LMX4
Active Ingredient: Lidocaine 4%w/w
Dosage Form: Topical cream
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Ferndale Laboratories Inc, Michigan, United States of America
Product: MeniCare Soft
Active Ingredient: Polihexanide 0.0001%w/w
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France
Product: Meni-LAB
Active Ingredient: Sodium hypochlorite 0.524%w/v equivalent to active chlorine 0.5%
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France
Product: Orion RX Imiquimod Cream 5%
Active Ingredient: Imiquimod 50mg/g
Dosage Form: Topical cream
New Zealand Sponsor: Orion Laboratories (NZ) Limited
Manufacturer: Perrigo Israel Pharmaceuticals Limited, Yeruham, Israel
Dated this 28th day of November 2013.
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).