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: BioTest
Active Ingredients: Goat anti-alpha-hCG polyclonal antibody 2µg
Goat anti-mouse polyclonal antibody 3µg
Murine monoclonal antibody to beta HCG 3µg
Dosage Form: Pregnancy test kit (Mid-Stream)
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Atlas Medical, King Abdullah the II Industrial Estate, Sahab Free Zone Area, Amman, Jordan
Product: BioTest
Active Ingredients: Goat anti-alpha-hCG polyclonal antibody 2µg
Goat anti-mouse polyclonal antibody 3µg
Murine monoclonal antibody to beta HCG 3µg
Dosage Form: Pregnancy test kit (Cassette)
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Atlas Medical, King Abdullah the II Industrial Estate, Sahab Free Zone Area, Amman, Jordan
Product: Fexofenadine
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Andhra Pradesh, India
Product: Fexofenadine
Active Ingredient: Fexofenadine hydrochloride 180mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Andhra Pradesh, India
Product: Risperon
Active Ingredient: Risperidone 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited (part of Mylan)
Manufacturer: Dar Al Dawa Development & Investment Co. of Prince Hashim, Nau’r Jordan, Jordan
Product: Sebivo
Active Ingredient: Telbivudine 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Zostavax
Active Ingredient: Varicella vaccine 19,400PFU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturers: Hollister-Stier, Spokane, Washington, United States of America
Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Zyprexa Adhera
Active Ingredient: Olanzapine embonate monohydrate 483mg equivalent to 210mg olanzapine
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Product: Zyprexa Adhera
Active Ingredient: Olanzapine embonate monohydrate 690mg equivalent to 300mg olanzapine
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Product: Zyprexa Adhera
Active Ingredient: Olanzapine embonate monohydrate 931mg equivalent to 405mg olanzapine
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Eli Lilly and Co, Lilly Technology Centre, Indianapolis, Indiana, United States of America
Dated this 4th day of September 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).