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: Actigall
Active Ingredient: Ursodeoxycholic acid 300mg
Dosage Form: Capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Watson Laboratories Inc, New York, United States of America
Watson Pharma Private Limited, Goa, India
Product: AFT-Leflunomide
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, St Laurent, Canada
Product: AFT-Leflunomide
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, St Laurent, Canada
Product: Carboplatin
Active Ingredient: Carboplatin 10mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Salcette, India
Product: Dimetapp PE Nasal Decongestant
Active Ingredient: Phenylephrine hydrochloride 10mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Catalent Australia Pty Limited, Braeside, Australia
Product: Fluoxetine - AFT
Active Ingredient: Fluoxetine hydrochloride 4mg/mL equivalent to fluoxetine 20mg per 5mL
Dosage Form: Oral solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pinewood Laboratories Limited, Clonmel, Ireland
Product: Obecalpton
Active Ingredients: Codeine phosphate hemihydrate 8mg equivalent to 5.92mg codeine
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
Product: Ovestin Ovula
Active Ingredient: Oestriol 0.5mg
Dosage Form: Pessary
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Unither Industries, Gannat, France
Product: Panadol Sinus PE Night & Day
Day tablet
Active Ingredients: Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
Night tablet
Active Ingredients: Chlorphenamine maleate 2mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Australia Pty Limited, Ermington, Australia
Product: Pharmacist’s Own Pain Relief
Active Ingredients: Codeine phosphate hemihydrate 10mg
Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited trading as API Consumer Brands
Manufacturer: PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand
Product: SOMAC Heartburn Relief
Active Ingredient: Pantoprazole sodium sesquihydrate 22.57mg equivalent to pantoprazole 20mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Research Associates Limited
Manufacturers: Nycomed GmbH, Oranienburg, Germany
Advance Pharma GmbH, Berlin, Germany
Product: Sulphacetamide Sodium Eye Drops
Active Ingredient: Sulfacetamide sodium monohydrate 100mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Alcon New Zealand Limited
Manufacturer: Alcon Manufacturing Limited, Forth Worth, United States of America
Product: Taxotere
Active Ingredient: Docetaxel, anhydrous 20mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Pharma, Essex, United Kingdom
Product: Taxotere
Active Ingredient: Docetaxel, anhydrous 40mg/mL
Dosage Form: Solution for Concentrate for infusion
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturers: Sanofi Chimie, Vitry-Sur-Seine, France
Aventis Pharma, Essex, United Kingdom
Pierre Fabre Medicament Production, Idron, France
Product: Telfast
Active Ingredient: Fexofenadine hydrochloride 60mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: sanofi-aventis us llc, Kansas City, United States of America
Product: Telfast
Active Ingredient: Fexofenadine hydrochloride 120mg
Dosage Form: Tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: sanofi-aventis us llc, Kansas City, United States of America
Dated this 30th day of September 2010.
JANICE WILSON, Deputy Director-General, Population Health Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).