✨ Medicines Consent Notices




2322

NEW ZEALAND GAZETTE

No. 90

Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24 (5) of the Act and is set out in the Schedule hereto.

Schedule

Product: Plavix

Active Ingredient(s): Clopidogrel hydrogen sulfate 97.875mg equivalent to 75 mg free base

Dosage Form: Film coated tablet

New Zealand Sponsor: Sanofi-Synthelabo (NZ) Limited

Manufacturer(s): Sanofi Winthrop Industrie, Ambares, France
Sanofi Winthrop Limited, Production Division, Fawdon, Newcastle-upon-Tyne, United Kingdom

Dated this 8th day of August 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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: Apo-Enalapril

Active Ingredient(s): Enalapril maleate 10mg

Dosage Form: Tablet

New Zealand Sponsor: Apotex NZ Limited

Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India

Product: Apo-Enalapril

Active Ingredient(s): Enalapril maleate 2.5mg

Dosage Form: Tablet

New Zealand Sponsor: Apotex NZ Limited

Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India

Product: Apo-Enalapril

Active Ingredient(s): Enalapril maleate 20mg

Dosage Form: Tablet

New Zealand Sponsor: Apotex NZ Limited

Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India

Product: Apo-Enalapril

Active Ingredient(s): Enalapril maleate 5mg

Dosage Form: Tablet

New Zealand Sponsor: Apotex NZ Limited

Manufacturer(s): Ranbaxy Laboratories Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himachal, Pradesh, India

Product: First Response Pregnancy Test

Active Ingredient(s): Antibody to HCG hormone 4.2Β΅g
Murine monoclonal antibody to HCG 3.2Β΅g

Dosage Form: Pregnancy test kit

New Zealand Sponsor: Wilson Consumer Products

Manufacturer(s): Princeton Biomeditech Corporation, Monmouth Junction, New Jersey, United States of America

Product: Omezol

Active Ingredient(s): Omeprazole 10mg

Dosage Form: Capsule

New Zealand Sponsor: Pacific Pharmaceuticals Limited

Manufacturer(s): Laboratorios Dr. Esteve SA, Santa Marti, Martorelles, Barcelona, Spain

Product: Omezol

Active Ingredient(s): Omeprazole 20mg

Dosage Form: Capsule

New Zealand Sponsor: Pacific Pharmaceuticals Limited

Manufacturer(s): Laboratorios Dr. Esteve SA, Santa Marti, Martorelles, Barcelona, Spain



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 90


Gazette.govt.nz PDF NZ Gazette 2001, No 90





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a Changed Medicine (continued from previous page)

πŸ₯ Health & Social Welfare
8 August 2001
Medicines, Plavix, Clopidogrel, Sanofi-Synthelabo, Medicines Act 1981
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
8 August 2001
Medicines, Apo-Enalapril, Enalapril, First Response Pregnancy Test, Omezol, Omeprazole, Medicines Act 1981
  • G. R. Boyd, Chief Advisor, Safety and Regulation