Medicines Approval Notices




NEW ZEALAND GAZETTE

27 JUNE

1907

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:
Cozaar
Active Ingredient:
Losartan potassium 12.5mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom

Product:
Cozaar
Active Ingredient:
Losartan potassium 50mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer:
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom

Product:
Fluarix
Active Ingredients:
Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1 – like strain 30µg/mL
Influenza virus haemagglutin B/Sichuan/379/99 – like strain 30µg/mL
Influenza virus haemagglutin type A/Moscow/10/99 H3N2 – like strain 30µg/mL
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Glaxo Wellcome New Zealand Limited
Manufacturers:
GlaxoSmithKline Biologicals, Rixensart, Belgium
Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany

Product:
Lipostat (original formulation)
Active Ingredient:
Pravastatin sodium 10mg
Dosage Form:
Tablet
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia

Product:
Lipostat (original formulation)
Active Ingredient:
Pravastatin sodium 20mg
Dosage Form:
Tablet
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia

Product:
Lipostat (original formulation)
Active Ingredient:
Pravastatin sodium 5mg
Dosage Form:
Tablet
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia

Product:
Lipostat
Active Ingredient:
Pravastatin sodium 40mg
Dosage Form:
Tablet
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturer:
Bristol-Myers Squibb Australia Pty Limited, Noble Park, Victoria, Australia

Product:
Plavix
Active Ingredient:
Clopidogrel hydrogen sulfate 97.875mg equivalent to 75 mg free base
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Sanofi-Synthelabo (NZ) Limited
Manufacturers:
Sanofi Winthrop Industrie, Ambares, France
Sanofi Winthrop Limited, Fawdon, Newcastle-upon-Tyne, United Kingdom

Product:
Recormon 10000 for Reco-Pen
Active Ingredient:
Epoetin beta 10,000IU
Dosage Form:
Powder for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany

Product:
Recormon 20000 for Reco-Pen
Active Ingredient:
Epoetin beta 20,000IU
Dosage Form:
Powder for injection
New Zealand Sponsor:
Roche Products (New Zealand) Limited
Manufacturer:
Vetter Pharma-Fertigung GmbH & Co Kg, Ravensburg, Germany



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 73


Gazette.govt.nz PDF NZ Gazette 2002, No 73





✨ LLM interpretation of page content

🏥 Consent to the Distribution of Changed Medicines (continued from previous page)

🏥 Health & Social Welfare
27 June 2002
Medicines Act, Changed Medicines, Cozaar, Fluarix, Lipostat, Plavix, Recormon, Merck Sharp & Dohme, Glaxo Wellcome, Bristol-Myers Squibb, Sanofi-Synthelabo, Roche Products
  • Minister of Health