✨ Medicine Consents




27 NOVEMBER

NEW ZEALAND GAZETTE

4475

Product: FEIBA TIM 4 IMMUNO
Active Ingredient: Factor VIII inhibitor bypassing fraction 1,000U
Dosage Form: Powder for injection
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter A G, Vienna, Austria

Product: Paracetamol (Handy Pack)
Active Ingredient: Paracetamol 500mg
Dosage Form: Tablet
New Zealand Sponsor: PSM Healthcare Limited
Manufacturer: PSM Healthcare Limited, Wiri, Auckland

Product: Tri-Profen Cold and Flu
Active Ingredients: Ibuprofen 200mg
Pseudoephedrine hydrochloride 30mg
Dosage Form: Tablet
New Zealand Sponsor: 3M New Zealand Limited
Manufacturer: 3M Pharmaceuticals Pty Limited, Thornleigh, New South Wales, Australia

Dated this 24th day of November 2003.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Replagal
Active Ingredient: Agalsidase alfa 1mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Health Consulting Group Limited
Manufacturer: Chesapeake Biological Laboratories Inc, Baltimore, Maryland, United States of America

Note: This consent is valid for two years from 18 October 2003.

Dated this 24th day of November 2003.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of 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 changed 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: Pulmozyme
Active Ingredient: Dornase alfa 1mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: Automatic Liquid Packaging Inc, Woodstock, Illinois, United States of America
Genentech Inc, South San Francisco, California, United States of America

Product: Synagis
Active Ingredient: Palivizumab 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Abbott Laboratories SpA, Campoverde di Aprilia, Latina, Italy
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany

Product: Synagis
Active Ingredient: Palivizumab 50mg
Dosage Form: Powder for injection
New Zealand Sponsor: Abbott Laboratories (NZ) Limited
Manufacturers: Abbott Laboratories SpA, Campoverde di Aprilia, Latina, Italy
Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2003, No 161


Gazette.govt.nz PDF NZ Gazette 2003, No 161





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
24 November 2003
Medicines Act 1981, New medicines, Distribution, FEIBA TIM 4 IMMUNO, Paracetamol, Tri-Profen Cold and Flu
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
24 November 2003
Medicines Act 1981, Provisional consent, Replagal, Agalsidase alfa
  • DON MATHESON, Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
24 November 2003
Medicines Act 1981, Changed medicines, Pulmozyme, Synagis, Dornase alfa, Palivizumab
  • DON MATHESON, Deputy Director-General, Public Health