✨ Medicines Distribution Consent




21 JUNE 2007

NEW ZEALAND GAZETTE, No. 69

1815

Product:
Fexofenadine – Rex
Active Ingredient:
Fexofenadine hydrochloride 120mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
REX Medical Limited
Manufacturer:
Cipla Limited, Manufacturing Division, District Raigad, (Maharashtra), India

Product:
Listerine Citrus Fresh Antiseptic Mouthwash
Active Ingredients:
Benzoic acid 0.115%w/v
Cineole 0.0922%w/v
Ethanol 22.271%v/v
Thymol 0.0639%w/v
Dosage Form:
Mouthwash
New Zealand Sponsor:
Johnson & Johnson (New Zealand) Limited
Manufacturer:
McNeil Manufacturing Pty Limited, Caringbah, NSW, Australia

Product:
Lucentis
Active Ingredient:
Ranibizumab 10mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Novartis New Zealand Limited Pharmaceutical Sector
Manufacturer:
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 14th day of June 2007.

BARRY BORMAN, Acting-Deputy Director-General, Public 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 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:
Helixate SF
Active Ingredient:
Octocog alfa 1,000IU
Dosage Form:
Powder for injection
Diluent
New Zealand Sponsor:
Bayer New Zealand Limited Pharmaceutical Division
Manufacturer:
Bayer Corporation, Biological Products, Berkeley, California, United States of America

Product:
Helixate SF
Active Ingredient:
Octocog alfa 250IU
Dosage Form:
Powder for injection
Diluent
New Zealand Sponsor:
Bayer New Zealand Limited Pharmaceutical Division
Manufacturer:
Bayer Corporation, Biological Products, Berkeley, California, United States of America

Product:
Helixate SF
Active Ingredient:
Octocog alfa 500IU
Dosage Form:
Powder for injection
Diluent
New Zealand Sponsor:
Bayer New Zealand Limited Pharmaceutical Division
Manufacturer:
Bayer Corporation, Biological Products, Berkeley, California, United States of America

Product:
Kogenate FS
Active Ingredient:
Octocog alfa 1,000IU
Dosage Form:
Powder for injection
Diluent
New Zealand Sponsor:
Bayer New Zealand Limited Pharmaceutical Division
Manufacturers:
Bayer Corporation, Biological Products, Berkeley, California, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product:
Kogenate FS
Active Ingredient:
Octocog alfa 250IU
Dosage Form:
Powder for injection
Diluent
New Zealand Sponsor:
Bayer New Zealand Limited Pharmaceutical Division
Manufacturers:
Bayer Corporation, Biological Products, Berkeley, California, United States of America
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2007, No 69


Gazette.govt.nz PDF NZ Gazette 2007, No 69





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
14 June 2007
Medicines, Distribution, Medicines Act 1981, Health
  • BARRY BORMAN, Acting-Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
Medicines, Distribution, Medicines Act 1981, Health