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-Bicalutamide
Active Ingredient: Bicalutamide 50mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Ontario, Canada
Product: Copaxone
Active Ingredient: Glatiramer acetate 20mg
Dosage Form: Solution for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Teva Pharmaceutical Industries Limited, Kfar Saba, Israel
Baxter Pharmaceutical Solutions LLC, Indiana, United States of America
Product: Desmopressin-PH&T
Active Ingredient: Desmopressin acetate trihydrate 0.2mg equivalent to desmopressin 0.178mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Kern Pharma SL, Barcelona, Spain
Product: Desmopressin-PH&T
Active Ingredient: Desmopressin acetate trihydrate 0.1mg equivalent to desmopressin 0.0890mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Kern Pharma SL, Barcelona, Spain
Product: Effient
Active Ingredient: Prasugrel hydrochloride 5.49mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly Corporate Centre, Indiana, United States of America
Product: Effient
Active Ingredient: Prasugrel hydrochloride 10.98mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly Corporate Centre, Indiana, United States of America
Product: Lemsip Max Sinus
Active Ingredients: Caffeine 25mg
Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg
Dosage Form: Capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturers: Reckitt Benckiser Healthcare (UK) Limited, North Humberside, United Kingdom
Perrigo UK Limited, Devon, United Kingdom
Product: Nevanac
Active Ingredient: Nepafenac 1mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Ltd
Manufacturer: Alcon Laboratories Inc, Texas, United States of America
Product: Olanzapine
Active Ingredient: Olanzapine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Olanzapine
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Olanzapine
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Dr Reddy’s New Zealand Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Andhra Pradesh, India
Product: Oratane
Active Ingredient: Isotretinoin 5mg
Dosage Form: Soft gelatin capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Swiss Caps AG, Kirchberg, Switzerland
Product: Revatio
Active Ingredient: Sildenafil citrate 28.09mg equivalent to sildenafil 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer PGM, Poce Sur Cisse, France
Dated this 31st day of July 2009.
STEWART JESSAMINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).