✨ Medicine Distribution Consents




27 NOVEMBER 2008      NEW ZEALAND GAZETTE, No. 182      4755

Product: Arava
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France

Product: Humira Pen
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Aesica Pharmaceuticals Limited, Queenborough, Kent, United Kingdom
Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Germany

Product: Humira
Active Ingredient: Adalimumab 50mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Vetter Pharma-Fertigung GmbH & Co Kg, Langenargen, Germany
Vetter Pharma-Fertigung GmbH & Co Kg, Germany
Wasserburger Arzneimittelwerk GmbH, Wasserburg, Germany

Product: Leflunomide Winthrop
Active Ingredient: Leflunomide 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France

Product: Leflunomide Winthrop
Active Ingredient: Leflunomide 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France

Product: Leflunomide Winthrop
Active Ingredient: Leflunomide 20mg
Dosage Form: Film coated tablet
New Zealand Sponsor: sanofi-aventis new zealand limited
Manufacturer: Aventis Intercontinental, Compeigne, France

Dated this 21st day of November 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(4a) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Prothrombinex-VF
Active Ingredients: Factor II 500IU
Factor IX 500IU
Factor X 500IU
Dosage Form: Powder for injection
Diluent
New Zealand Sponsor: CSL Biotherapies (NZ) Limited
Manufacturer: CSL Limited, Bioplasma Division, Broadmeadows, Victoria, Australia

Note: This renewed consent is valid for two years from 3 December 2008.

Dated this 21st day of November 2008.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2008, No 182





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
21 November 2008
Medicines, Distribution Consent, Arava, Leflunomide, sanofi-aventis, Aventis Intercontinental, Humira, Adalimumab, Abbott Laboratories
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Renewal of Provisional Consent to Distribution of Medicine

πŸ₯ Health & Social Welfare
21 November 2008
Medicines, Provisional Consent, Prothrombinex-VF, Factor II, Factor IX, Factor X, CSL Biotherapies
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate