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: Adcirca
Active Ingredient: Tadalafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe Inc, Carolina, Puerto Rico
Product: Calcium Effervescent
Active Ingredient: Calcium carbonate 1250mg equivalent to Elemental calcium 500mg
Dosage Form: Effervescent tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Cardioplegia Base
Active Ingredients: Citric acid monohydrate 0.07973g/L
Monobasic sodium phosphate dihydrate 0.06119g/L
Potassium chloride 2.181g/L
Sodium chloride 1.788g/L
Sodium citrate dihydrate 0.6412g/L
Trometamol 5.9g/L
Dosage Form: Solution
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Product: Cardioplegia Enriched
Active Ingredients: Aspartic acid 8.481g/L
Citric acid monohydrate 0.8188g/L
Glutamic acid 9.375g/L
Monobasic sodium phosphate dihydrate 0.6285g/L
Potassium chloride 2.5g/L
Sodium citrate dihydrate 6.585g/L
Sodium hydroxide 5.133g/L
Trometamol 9.097g/L
Dosage Form: Solution
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Product: Cardioplegia Enriched Paediatric
Active Ingredients: Aspartic acid 10.43g/L
Citric acid monohydrate 0.22476g/L
Glutamic acid 11.53g/L
Monobasic sodium phosphate dihydrate 0.1725g/L
Potassium chloride 2.15211g/L
Sodium citrate dihydrate 1.80768g/L
Sodium hydroxide 6.31g/L
Trometamol 11.2369g/L
Dosage Form: Solution
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Auckland, New Zealand
Product: Fendex ER
Active Ingredient: Felodipine 2.5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Fendex ER
Active Ingredient: Felodipine 5mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Fendex ER
Active Ingredient: Felodipine 10mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Mylan Pharmaceuticals Inc, West Virginia, United States of America
Product: Intelence
Active Ingredient: Etravirine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen-Cilag SpA, Latina, Italy
Product: Systane Ultra UD Lubricant Eye Drops
Active Ingredients: Macrogol 400 0.4%w/v
Propylene glycol 0.3%w/v
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Laboratories Alcon S.A., Kaysersberg, France
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to Erlotinib 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to Erlotinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to Erlotinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Roche SpA, Milan, Italy
Kremers Urban Pharmaceuticals Inc, Indiana, United States of America
Product: Vermox Choc Chews
Active Ingredient: Mebendazole 100mg
Dosage Form: Chewable tablet
New Zealand Sponsor: Biotech Pharmaceuticals (NZ) Pty Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia
Dated this 15th day of December 2011.
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).