✨ Medicines Distribution Notices




NEW ZEALAND GAZETTE, No. 64

10 JUNE 2010

Consent to the Distribution of Medicines

Product: Octanate
Active Ingredient: Factor VIII, human 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers:

  • Octapharma AB, Stockholm, Sweden
  • Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
  • Octapharma, Lingolsheim, France

Product: Octanate
Active Ingredient: Factor VIII, human 500IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers:

  • Octapharma AB, Stockholm, Sweden
  • Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
  • Octapharma, Lingolsheim, France

Product: Octanate
Active Ingredient: Factor VIII, human 1000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturers:

  • Octapharma AB, Stockholm, Sweden
  • Octapharma Pharmazeutika Produktions GmbH, Vienna, Austria
  • Octapharma, Lingolsheim, France

Dated this 3rd day of June 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Revocation of Consent to the Distribution of Medicines

Pursuant to section 35(1)(a) of the Medicines Act 1981, the Minister of Health hereby revokes consent to the distribution in New Zealand of the following medicines on 1 August 2010:

Product: Capadex
Active Ingredients:

  • Dextropropoxyphene hydrochloride 32.5mg
  • Paracetamol 325mg
    Dosage Form: Powder filled capsule
    New Zealand Sponsor: Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics

Product: Paradex
Active Ingredients:

  • Dextropropoxyphene napsilate monohydrate 50mg
  • Paracetamol 325mg
    Dosage Form: Tablet
    New Zealand Sponsor: PSM Healthcare Limited trading as SPI Consumer Brands

Dated this 3rd day of June 2010.

STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 20 December 2001 and the Director-General of Health on 18 January 2002).

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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: alli
Active Ingredient: Orlistat 60mg
Dosage Form: Capsule
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturer: GlaxoSmithKline Consumer Healthcare LP, Aiken, United States of America

Product: Azocin 500 mg
Active Ingredient: Azithromycin monohydrate 512mg equivalent to 500mg azithromycin
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Sandoz SrL, Targu Mures, Romania



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2010, No 64





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
3 June 2010
Medicines Act, Consent, Octanate, Factor VIII, Powder for injection
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Revocation of Consent to the Distribution of Medicines

πŸ₯ Health & Social Welfare
3 June 2010
Medicines Act, Revocation, Capadex, Paradex, Dextropropoxyphene, Paracetamol
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
3 June 2010
Medicines Act, Consent, alli, Orlistat, Azocin, Azithromycin
  • STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health