Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

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: Amlodipine
Active Ingredient: Amlodipine besilate 13.888mg equivalent to 10mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Airflow Products Limited
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary
Product: Amlodipine
Active Ingredient: Amlodipine besilate 6.944mg equivalent to amlodipine 5mg
Dosage Form: Tablet
New Zealand Sponsor: Airflow Products Limited
Manufacturer: Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary
Product: Cathejell
Active Ingredients: Chlorhexidine hydrochloride 0.05%w/wLidocaine 2%w/w
Dosage Form: Topical gel
New Zealand Sponsor: USL Medical Consumer Products
Manufacturer: Montavit GmbH, Absam, Tirol, Austria
Product: Emnorm
Active Ingredient: Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Emnorm
Active Ingredient: Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Letrozole Sandoz
Active Ingredient: Letrozole 2.5mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Metformin
Active Ingredients: Metformin hydrochloride 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Metformin
Active Ingredient: Metformin hydrochloride 850mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Ipca Pharma (NZ) Pty Limited
Manufacturer: Ipca Laboratories Limited, Athal, Silvassa, Dadra and Nagar Haveli (U T), India
Product: Paroven Forte
Active Ingredient: Hydroxyethylrutosides 500mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturer: Novartis Farmaceutica SA, Barbera del Valles, Barcelona, Spain
Product: Polaramine Colour Free Repetabs
Active Ingredient: Dexchlorpheniramine maleate 6mg
Dosage Form: Tablet
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Laboratories NV, Heist-op-den-Berg, Belgium
Product: Restylane Lipp
Active Ingredient: Sodium hyaluronate 20mg/mL
Dosage Form: Gel for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Q-Med AB, Uppsala, Sweden
Product: Restylane Perlane
Active Ingredient: Sodium hyaluronate 20mg/mL
Dosage Form: Gel for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Q-Med AB, Uppsala, Sweden
Product: Restylane SubQ
Active Ingredient: Sodium hyaluronate 20mg/mL
Dosage Form: Gel for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Q-Med AB, Uppsala, Sweden
Product: Restylane Touch
Active Ingredient: Sodium hyaluronate 20mg/mL
Dosage Form: Gel for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Q-Med AB, Uppsala, Sweden
Product: Restylane Vital
Active Ingredient: Sodium hyaluronate 20mg/mL
Dosage Form: Gel for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Q-Med AB, Uppsala, Sweden
Product: Restylane
Active Ingredient: Sodium hyaluronate 20mg/mL
Dosage Form: Gel for injection
New Zealand Sponsor: Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics
Manufacturer: Q-Med AB, Uppsala, Sweden
Product: Stalevo
Active Ingredients: Carbidopa monohydrate 54.1mg equivalent to 50mg carbidopaEntacapone 200mg Levodopa 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Pharma, Espoo, Finland
Product: Vicks Cough Syrup Honey Flavour Chesty Cough
Active Ingredient: Guaifenesin 13.33mg/mL
Dosage Form: Film coated tablet
New Zealand Sponsor: Procter & Gamble Distributing New Zealand
Manufacturer: Procter & Gamble GmbH, Gross Gerau, Germany
Dated this 31st day of October 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).