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: ADACEL
Active Ingredients: Diphtheria toxoid, adsorbed 2IU
Pertactin 3µg
Pertussis filamentous haemagglutinin 5µg
Pertussis fimbriae 2+3 5µ
Pertussis toxoid, adsorbed 2.5µg
Tetanus toxoid 20IU
Dosage Form: Suspension for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Pasteur Limited, Toronto, Ontario, Canada
Product: BYETTA 10
Active Ingredient: Exenatide 250µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (New Zealand) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Wockhardt UK Limited, Wrexham Industrial Estate, Wrexham, United Kingdom
Product: BYETTA 5
Active Ingredient: Exenatide 250µg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Eli Lilly and Company (New Zealand) Limited
Manufacturers: Baxter Pharmaceutical Solutions LLC, Bloomington, Indiana, United States of America
Wockhardt UK Limited, Wrexham Industrial Estate, Wrexham, United Kingdom
Product: Emend
Active Ingredient: Aprepitant 40mg
Dosage Form: Capsule
New Zealand Sponsor: Merck Sharp & Dohme (New Zealand) Limited
Manufacturer: Merck & Co Inc, West Point, Pennsylvania, United States of America
Product: Hydroxocobalamin ABM
Active Ingredient: Hydroxocobalamin acetate 1mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: ABM Pharma Limited
Manufacturer: Rotexmedica GmbH, Trittau, Germany
Product: Nexavar
Active Ingredient: Sorafenib tosilate 274mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Healthcare AG, Bayerwerk, Germany
Product: Terazosin
Active Ingredient: Terazosin hydrochloride dihydrate 1.19mg equivalent to 1mg terazosin
Dosage Form: Tablet
New Zealand Sponsor: Accord Healthcare (New Zealand) Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: Terazosin
Active Ingredient: Terazosin hydrochloride dihydrate 2.38mg equivalent to 2mg terazosin
Dosage Form: Tablet
New Zealand Sponsor: Accord Healthcare (New Zealand) Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Product: Terazosin
Active Ingredient: Terazosin hydrochloride dihydrate 5.95mg equivalent to 5mg terazosin
Dosage Form: Tablet
New Zealand Sponsor: Accord Healthcare (New Zealand) Limited
Manufacturer: Intas Pharmaceuticals Limited, Matoda, Gujarat, India
Dated this 24th day of May 2007.
KAREN MITCHELL, Acting-Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).