✨ Medicines Distribution Consent




19 DECEMBER 2013 NEW ZEALAND GAZETTE, No. 172 4703

Schedule

Product: Codral Multi Action Cold & Flu
Active Ingredients: Chlorphenamine maleate 2mg
Codeine phosphate hemihydrate 9.5mg
Paracetamol 500mg
Phenylephrine hydrochloride 5mg
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Probiotec Pharma Pty Limited, Melbourne, Australia

Product: Protamine Sulphate
Active Ingredient: Protamine sulfate 1%
Dosage Form: Solution for injection
New Zealand Sponsor: Artex Limited
Manufacturers: Agila Specialties Polska Sp. z o.o, Warsaw, Poland
CP Pharmaceuticals Limited, Wrexham, United Kingdom

Product: Voltaren Emulgel
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany

Product: Voltaren Osteo
Active Ingredient: Diclofenac diethylamine 1.16% equivalent to Diclofenac 1%
Dosage Form: Topical gel
New Zealand Sponsor: Novartis Consumer Health Australasia Pty Limited (New Zealand)
Manufacturers: Novartis Consumer Health SA, Nyon, Switzerland
Novartis Pharma Produktions GmbH, Wehr, Germany

Dated this 16th day of December 2013.

SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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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: Arrow - Efavirenz
Active Ingredient: Efavirenz 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Emcure Pharmaceuticals Limited, Pune, India

Product: Aubagio
Active Ingredient: Teriflunomide 14mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Sanofi Winthrop Industrie, Compiegne, France

Product: Bimopt
Active Ingredient: Bimatoprost 0.3mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Micro Labs Limited, Bangalore, India

Product: Clinpro 5000 (Bubblegum)
Active Ingredient: Sodium fluoride 1.12%
Dosage Form: Toothpaste
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: Sheffield Pharmaceuticals, Connecticut, United States of America



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 172





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
16 December 2013
Medicines Act 1981, New Medicines, Distribution, Minister of Health
  • SARAH READER, Acting Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Distribution, Minister of Health