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: Brufen (pharmacy only)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Brufen (prescription medicine)
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Cleviprex
Active Ingredient: Clevidipine 0.5mg/mL
Dosage Form: Emulsion for injection
New Zealand Sponsor: CARSL Consulting
Manufacturer: Hospira Inc, North Carolina, United States of America
Product: Doribax
Active Ingredient: Doripenem 500mg
Dosage Form: Powder for infusion
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Shionogi & Co Limited, Iwate, Japan
Product: Olanzine
Active Ingredient: Olanzapine 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Olanzine
Active Ingredient: Olanzapine 7.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Olanzine
Active Ingredient: Olanzapine 5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Olanzine
Active Ingredient: Olanzapine 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Alphapharm Pty Limited, Brisbane, Queensland, Australia
Product: Oxaliplatin Ebewe
Active Ingredient: Oxaliplatin 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Oncotec Pharma Produktion GmbH, Dessau Rosslau, Germany
Product: Oxaliplatin Ebewe
Active Ingredient: Oxaliplatin 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: Oncotec Pharma Produktion GmbH, Dessau Rosslau, Germany
Product: Reduxade
Active Ingredient: Sibutramine hydrochloride monohydrate 10mg
Dosage Form: Capsule
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Reduxade
Active Ingredient: Sibutramine hydrochloride monohydrate 15mg
Dosage Form: Capsule
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Abbott GmbH & Co. KG, Ludwigshafen, Germany
Product: Sculptra
Active Ingredient: Poly(lactic acid) 150mg
Dosage Form: Powder for injection
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Dermik Laboratories a business of Sanofi-Aventis U.S. LLC, Bridgewater, New Jersey, United States of America
Gruppo Lepetit SRL, Anagni, Italy
Product: Temodal
Active Ingredient: Temozolomide 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Baxter Oncology GmbH, Halle-Kunsebeck, Germany
Dated this 24th day of July 2009.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).