Consent to Distribution of Medicines




NEW ZEALAND GAZETTE

No. 161

Product:
First Response Plus

Active Ingredient:
Antibody to HCG hormone 4.2 Murine monoclonal antibody to HCG 3.2µg

Dosage Form:
Pregnancy test kit

New Zealand Sponsor:
Wilson Consumer Products

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

Product:
Zelmac

Active Ingredient:
Tegaserod maleate 8.31mg equivalent to 6mg tegaserod

Dosage Form:
Tablet

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer:
Novartis Pharma Stein AG, Stein, Switzerland

Dated this 24th day of October 2002.

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 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:
Lipex

Active Ingredient:
Simvastatin 10mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturers:
Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Lipex

Active Ingredient:
Simvastatin 20mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturers:
Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Lipex

Active Ingredient:
Simvastatin 40mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturers:
Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Lipex

Active Ingredient:
Simvastatin 5mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturers:
Merck & Co Inc, West Point, Pennsylvania, United States of America
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Lipex

Active Ingredient:
Simvastatin 80mg

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:
Losec

Active Ingredient:
Omeprazole 10mg

Dosage Form:
Capsule

New Zealand Sponsor:
AstraZeneca Limited

Manufacturers:
AstraZeneca AB, Södertälje, Sweden
AstraZeneca UK Limited, Headway, Great Oakley, Corby, Northamptonshire, United Kingdom



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 161


Gazette.govt.nz PDF NZ Gazette 2002, No 161





✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines

🏥 Health & Social Welfare
24 October 2002
Medicines, Distribution, First Response Plus, Zelmac, Pregnancy Test Kit, Tablet
  • G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of Changed Medicines

🏥 Health & Social Welfare
Medicines, Distribution, Lipex, Losec, Simvastatin, Omeprazole, Film Coated Tablet, Capsule