New Medicines Consent




18 JULY

NEW ZEALAND GAZETTE

2147

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) Limited
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 400µg equivalent to 320µg delivered dose
Formoterol fumarate 12µg equivalent to 9µg 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).

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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:
3M Avagard 8615 Pre-Surgical Skin Preparation with Povidone Iodine
Active Ingredient:
Iodine 1%w/w
Dosage Form:
Topical solution
New Zealand Sponsor:
3M New Zealand Ltd
Manufacturer:
3M Pharmaceuticals (Australia) Pty Ltd, Thornleigh, New South Wales, Australia



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 81


Gazette.govt.nz PDF NZ Gazette 2002, No 81





✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines (continued from previous page)

🏥 Health & Social Welfare
10 July 2002
Medicines Act 1981, New Medicines, Co-Diovan, Comtan, Cosudex, Dimetapp DM, Fluox, Hemohes, Symbicort, Novartis, AstraZeneca, Whitehall Consumer Healthcare, Pacific Pharmaceuticals, Biomed
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of New Medicines

🏥 Health & Social Welfare
Medicines Act 1981, New Medicines, 3M Avagard, Povidone Iodine, 3M New Zealand Ltd, 3M Pharmaceuticals (Australia)