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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Cialis
Active Ingredient: Tadalafil 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe Inc, Carolina, Puerto Rico
Product: Cialis
Active Ingredient: Tadalafil 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe Inc, Carolina, Puerto Rico
Product: Cialis
Active Ingredient: Tadalafil 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly del Caribe Inc, Carolina, Puerto Rico
Lilly SA, Madrid, Spain
Product: Cialis
Active Ingredient: Tadalafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturers: Lilly del Caribe Inc, Carolina, Puerto Rico
Lilly SA, Madrid, Spain
Product: Omegaven
Active Ingredients: Egg lecithin 1.2%w/v
Fish oil 10%w/v
Glycerol 2.5%w/v
Dosage Form: Emulsion for infusion
New Zealand Sponsor: Fresenius Kabi New Zealand Limited
Manufacturers: Fresenius Kabi Austria GmbH, Graz, Austria
Fresenius Kabi Deutschland GmbH, Friedberg, Germany
Dated this 9th day of January 2013.
DR STEWART JESSAMINE, 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).