✨ Medicines Distribution Consent




14 NOVEMBER 2013 NEW ZEALAND GAZETTE, No. 150 4149

Product: Arrow - Aripiprazole
Active Ingredient: Aripiprazole 30mg
Dosage Form: Tablet
New Zealand Sponsor: Actavis New Zealand Limited
Manufacturer: Unichem Laboratories Limited, Ghaziabad, India

Product: Benztrop
Active Ingredient: Benzatropine mesilate 2mg
Dosage Form: Tablet
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Pharmascience Inc, Quebec, Canada

Product: Capecitabine Winthrop
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Remedica Limited, Limassol, Cyprus

Product: Capecitabine Winthrop
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Remedica Limited, Limassol, Cyprus

Product: NicoQuit (Mint)
Active Ingredient: Nicotine polacrilex 14.9mg equivalent to Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark

Product: NicoQuit (Mint)
Active Ingredient: Nicotine polacrilex 29.9mg equivalent to Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark

Product: NicoQuit (Fruit)
Active Ingredient: Nicotine polacrilex 14.9mg equivalent to Nicotine 2mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle, Denmark

Product: NicoQuit (Fruit)
Active Ingredient: Nicotine polacrilex 29.9mg equivalent to Nicotine 4mg
Dosage Form: Chewing gum
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Fertin Pharma A/S, Vejle Denmark

Dated this 7th day of November 2013.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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 which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product: Galvus
Active Ingredient: Vildagliptin 50mg
Dosage Form: Tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Farmaceutica SA, Barcelona, Spain
Novartis Pharma Stein AG, Stein, Switzerland



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 150





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
7 November 2013
Medicines, Consent, Distribution, Arrow - Aripiprazole, Benztrop, Capecitabine Winthrop, NicoQuit, Galvus
  • DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health