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: Betaxolol
Active Ingredient: Betaxolol hydrochloride 0.56%w/v equivalent to betaxolol 0.5%
Dosage Form: Eye drops, solution
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, Goa, India
Product: Carvelol
Active Ingredient: Carvedilol 12.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Specifar SA, Aigaleo, Athens, Greece
Product: Carvelol
Active Ingredient: Carvedilol 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Specifar SA, Aigaleo, Athens, Greece
Product: Carvelol
Active Ingredient: Carvedilol 3.125mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Specifar SA, Aigaleo, Athens, Greece
Product: Carvelol
Active Ingredient: Carvedilol 6.25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Specifar SA, Aigaleo, Athens, Greece
Product: Fosamax Plus
Active Ingredients: Alendronate sodium trihydrate 91.37mg equivalent to 70mg alendronic acid
Colecalciferol 140µg equivalent to 5600 IU
Dosage Form: Tablet
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: MSD Frosst Iberica SA, Alcala de Henares, Madrid, Spain
Product: Invega
Active Ingredient: Paliperidone 12mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Invega
Active Ingredient: Paliperidone 3mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Invega
Active Ingredient: Paliperidone 6mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Invega
Active Ingredient: Paliperidone 9mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Alza Corporation, Vacaville, California, United States of America
Product: Lantus OptiSet
Active Ingredient: Insulin glargine 3.6378mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany
Dated this 27th day of May 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).