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
Active Ingredient: Ibuprofen 600mg
Dosage Form: LXDC formulation Film coated tablet
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturer: Laboratoires Knoll France SA, Valenciennes Cedex, France
Product: Co-Diovan
Active Ingredients: Hydrochlorothiazide 12.5mg
Valsartan 160mg
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 160mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Comtan
Active Ingredient: Entacapone 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Orion Corporation Farmos, Espoo, Finland
Product: Cosudex
Active Ingredient: Bicalutamide 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca GmbH, Plankstadt, Germany
Product: Dimetapp DM Cold & Cough Colour Free Paediatric Drops
Active Ingredients: Brompheniramine maleate 0.4mg/mL
Dextromethorphan hydrobromide 2mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Oral drops
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limted
Manufacturer: Interphil Laboratories Inc, Pittland, Cabuyao, Laguna, Philippines
Product: Dimetapp DM Cold & Cough Colour Free
Active Ingredients: Brompheniramine maleate 0.4mg/mL
Dextromethorphan hydrobromide 2mg/mL
Phenylephrine hydrochloride 1mg/mL
Dosage Form: Elixir
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer: Interphil Laboratories Inc, Pittland, Cabuyao, Laguna, Philippines
Product: Fluox
Active Ingredient: Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20mg
Dosage Form: Dispersible tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alphapharm Pty Limited, Carole Park, Brisbane, Queensland, Australia
Product: Hemohes
Active Ingredient: Poly-O-(2-hydroxyethyl)-starch 10%w/v
Dosage Form: Solution for injection
New Zealand Sponsor: Biomed Limited
Manufacturer: Biomed Limited, Pt Chevalier, Auckland
Product: Symbicort 400/12 Turbuhaler
Active Ingredients: Budesonide 400Ág equivalent to 320Ág delivered dose
Formoterol fumarate 12Ág equivalent to 9Ág eformoterol fumarate per delivered dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Dated this 10th day of July 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).