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: Arrow - Fluoxetine
Active Ingredient: Fluoxetine hydrochloride 22.5mg equivalent to Fluoxetine 20mg
Dosage Form: Capsule
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Ltd, Tamil Nadu, India
Product: Bicalutamide
Active Ingredient: Bicalutamide 50mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Elonva
Active Ingredient: Corifollitropin alfa 0.2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Elonva
Active Ingredient: Corifollitropin alfa 0.3mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany
Product: Menactra
Active Ingredient: Meningococcal polysaccharide 4µg of each of Groups A, C, Y & W-135, each separately conjugated to diphtheria toxoid, 48µg total
Dosage Form: Solution for injection
New Zealand Sponsor: Sanofi-Aventis New Zealand Limited
Manufacturer: Sanofi Pasteur Inc, Pennsylvania, United States of America
Product: Viramune
Active Ingredient: Nevirapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Ohio, United States of America
Product: Viramune
Active Ingredient: Nevirapine hemihydrate 10.35mg/mL equivalent to Nevirapine 10mg/mL
Dosage Form: Oral suspension
New Zealand Sponsor: Boehringer Ingelheim (NZ) Limited
Manufacturer: Boehringer Ingelheim Roxane Inc, Ohio, United States of America
Dated this 1st day of March 2012.
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).