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: Afinitor
Active Ingredient: Everolimus 5mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland
Product: Afinitor
Active Ingredient: Everolimus 10mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma AG, Basel, Switzerland
Novartis Pharma Stein AG, Stein, Switzerland
Product: Co-Diovan
Active Ingredients: Hydrochlorothiazide 12.5mg
Valsartan 320mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Co-Diovan
Active Ingredients: Hydrochlorothiazide 25mg
Valsartan 320mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Docetaxel Ebewe
Active Ingredient: Docetaxel, anhydrous 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmaco (NZ) Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Product: Lemsip Max All-In-One Cold & Flu
Active Ingredients: Guaifenesin 100mg
Paracetamol 500mg
Phenylephrine hydrochloride 6.1mg equivalent to 5mg phenylephrine
Dosage Form: Capsule
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom
Product: Vimpat
Active Ingredient: Lacosamide 50mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturers: Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Schwarz Pharma Produktions-GmbH, Zwickau, Germany
Product: Vimpat
Active Ingredient: Lacosamide 100mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturers: Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Schwarz Pharma Produktions-GmbH, Zwickau, Germany
Product: Vimpat
Active Ingredient: Lacosamide 150mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturers: Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Schwarz Pharma Produktions-GmbH, Zwickau, Germany
Product: Vimpat
Active Ingredient: Lacosamide 200mg
Dosage Form: Tablet
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturers: Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Schwarz Pharma Produktions-GmbH, Zwickau, Germany
Product: Vimpat
Active Ingredient: Lacosamide 15mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Product: Vimpat
Active Ingredient: Lacosamide 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Pharmabroker Sales Limited
Manufacturer: EBEWE Pharma GmbH Nfg KG, Unterach am Attersee, Austria
Dated this 17th day of September 2009.
STUART POWELL, 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).