✨ Medicines Consent Notices




2036 NEW ZEALAND GAZETTE No. 84

Product:
Singulair
Active Ingredient(s):
Montelukast sodium 10.4mg equivalent to 10mg montelukast free acid
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s):
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Zocor
Active Ingredient(s):
Simvastatin 10mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s):
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:
Zocor
Active Ingredient(s):
Simvastatin 20mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s):
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:
Zocor
Active Ingredient(s):
Simvastatin 40mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s):
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:
Zocor
Active Ingredient(s):
Simvastatin 5mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s):
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:
Zocor
Active Ingredient(s):
Simvastatin 80mg
Dosage Form:
Film coated tablet
New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited
Manufacturer(s):
Merck Sharp & Dohme UK Limited, Cramlington, Northumberland, United Kingdom

Dated this 19th day of July 2000.

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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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Exelon
Active Ingredient(s):
Rivastigmine hydrogen tartrate 3.2mg/mL equivalent to 2mg/mL rivastigmine base
Dosage Form:
Oral solution
New Zealand Sponsor:
Novartis New Zealand Limited
Manufacturer(s):
Novartis Pharma SA, Orleans Cedex 2, France

Note: This consent is valid for 2 years from the date of publication of this notice.

Dated this 19th day of July 2000.

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

go5367



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2000, No 84


Gazette.govt.nz PDF NZ Gazette 2000, No 84





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
19 July 2000
Medicines, Distribution Consent, Montelukast sodium, Simvastatin
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
19 July 2000
Medicines, Provisional Consent, Rivastigmine hydrogen tartrate, Exelon
  • G. R. Boyd, Chief Advisor, Safety and Regulation