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: Apo-Cilazapril/HCTZ
Active Ingredients: Cilazapril monohydrate 5.22mg equivalent to 5mg cilazapril
Hydrochlorothiazide 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Weston, Ontario, Canada
Product: Arrow - Meloxicam
Active Ingredient: Meloxicam 7.5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Mississauga, Ontario, Canada
Product: Arrow - Testosterone
Active Ingredient: Testosterone undecylate 40mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Procaps S.A., Raranquila, Colombia
Product: Arrow-Enalapril
Active Ingredient: Enalapril maleate 10mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow-Enalapril
Active Ingredient: Enalapril maleate 20mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Arrow-Enalapril
Active Ingredient: Enalapril maleate 5mg
Dosage Form: Tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Arrow Laboratories Limited, Croydon, Victoria, Australia
Product: Aspartate - Glutamate
Active Ingredients: Monosodium glutamate 10.67g
Sodium aspartate 9.87g
Dosage Form: Solution for infusion
New Zealand Sponsor: Biomed Limited, Point Chevalier, Auckland, New Zealand
Manufacturer: Biomed Limited, Point Chevalier, Auckland, New Zealand
Product: Herceptin
Active Ingredient: Trastuzumab 440mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, South San Francisco, California, United States of America
Product: Herceptin
Active Ingredient: Trastuzumab 150mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Product: Ondansetron-Claris
Active Ingredient: Ondansetron hydrochloride dihydrate 2.49mg/mL equivalent to 2mg Ondansetron
Dosage Form: Solution for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Claris Life Sciences Limited, Chacharwadi-Vasana, Ahmedabad, Gujarat, India
Product: Plavix
Active Ingredient: Clopidogrel bisulfate, 391.5mg equivalent to 300mg clopidogrel
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis New Zealand Limited
Manufacturer: Sanofi Winthrop Industrie, Ambares Et Lagrave, Carbon Blanc Cedex, France
Product: Ranbaxy-Losartan
Active Ingredient: Losartan potassium 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Ranbaxy-Losartan
Active Ingredient: Losartan potassium 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Ranbaxy-Losartan
Active Ingredient: Losartan potassium 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Product: Ranbaxy-Losartan
Active Ingredient: Losartan potassium 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Ranbaxy Laboratories Limited, Dewas, Madhya Pradesh, India
Dated this 27th day of August 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health 6 July 2001).