β¨ 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 —
NZ Gazette 2001, No 90
Gazette.govt.nz —
NZ Gazette 2001, No 90
β¨ LLM interpretation of page content
π₯
Consent to the Distribution of a Changed Medicine
(continued from previous page)
π₯ Health & Social Welfare8 August 2001
Medicines, Plavix, Clopidogrel, Sanofi-Synthelabo, Medicines Act 1981
- G. R. Boyd, Chief Advisor, Safety and Regulation
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare8 August 2001
Medicines, Apo-Enalapril, Enalapril, First Response Pregnancy Test, Omezol, Omeprazole, Medicines Act 1981
- G. R. Boyd, Chief Advisor, Safety and Regulation