✨ Medicines Act Notices




NEW ZEALAND GAZETTE, No. 145

1 OCTOBER 2009


Medicines Act 1981

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: Thalidomide Pharmion
Active Ingredient: Thalidomide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Penn Pharmaceutical Services Limited, Tredegar, Gwent, United Kingdom

Note: This consent is given subject to the following conditions and is valid to 18 December 2011:

  • Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.
  • Douglas Pharmaceuticals Limited will manage the risk management programme relating to the distribution and use of Thalidomide.

Dated this 25th day of September 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, 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 a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Ibuprofen
Active Ingredient: Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Bangalore, India

Dated this 25th day of September 2009.

MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, 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 Changed 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: Aclasta
Active Ingredient: Zoledronic acid 0.05mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Product: Kogenate FS
Active Ingredient: Octocog alfa 2000IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, United States of America

Product: Kogenate FS
Active Ingredient: Octocog alfa 250IU
Dosage Form: Powder for injection
New Zealand Sponsor: Bayer New Zealand Limited
Manufacturer: Bayer Corporation, Berkeley, United States of America

Product: Kogenate FS
Active Ingredient: Octocog alfa 500IU
Dosage Form: Powder for injection



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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2009, No 145





✨ LLM interpretation of page content

πŸ₯ Renewal of Provisional Consent to the Distribution of Thalidomide Pharmion

πŸ₯ Health & Social Welfare
25 September 2009
Medicines Act, Provisional Consent, Thalidomide, Distribution
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of Ibuprofen

πŸ₯ Health & Social Welfare
25 September 2009
Medicines Act, Consent, Ibuprofen, Distribution
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
25 September 2009
Medicines Act, Consent, Changed Medicines, Distribution
  • MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health