✨ Medicines Distribution Consents




18 OCTOBER

NEW ZEALAND GAZETTE

3593

Consent to the Distribution of a New Related Product

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new related product set out in the Schedule hereto:

Schedule

Product:
Macleans Multi-Action + Whitening

Active Ingredient(s):
Sodium fluoride 0.22%w/w

Dosage Form:
Oral paste

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, N.S.W., Australia

Product:
Macleans Whitening Fresh

Active Ingredient(s):
Sodium fluoride 0.22%w/w

Dosage Form:
Oral paste

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, N.S.W., Australia

Product:
Macleans Whitening

Active Ingredient(s):
Sodium fluoride 0.22%w/w

Dosage Form:
Oral paste

New Zealand Sponsor:
SmithKline Beecham (NZ) Limited

Manufacturer(s):
GlaxoSmithKline Australia Pty Limited, Consumer Healthcare, Ermington, N.S.W., Australia

Dated this 10th day of October 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 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:
Dysport

Active Ingredient(s):
Clostridium botulinum type A toxin haemagglutinin complex 500U

Dosage Form:
Powder for injection

New Zealand Sponsor:
New Zealand Medical & Scientific Limited

Manufacturer(s):
Ispen Limited, Clwyd, United Kingdom

Product:
Vioxx

Active Ingredient(s):
Rofecoxib 2.5mg/mL

Dosage Form:
Oral suspension

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

Manufacturer(s):
Merck & Co Inc, Merck Manufacturing Division, West Point, Pennsylvania, United States of America

Product:
Vioxx

Active Ingredient(s):
Rofecoxib 5mg/mL

Dosage Form:
Oral suspension

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

Manufacturer(s):
Merck & Co Inc, Merck Manufacturing Division, West Point, Pennsylvania, United States of America

Product:
Vioxx

Active Ingredient(s):
Rofecoxib 12.5mg

Dosage Form:
Tablet

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

Manufacturer(s):
Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Product:
Vioxx

Active Ingredient(s):
Rofecoxib 25mg

Dosage Form:
Tablet

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

Manufacturer(s):
Merck Manufacturing Division of Merck and Co, Bo. Sabana Hoyos, Arecibo, Puerto Rico
Merck Sharp and Dohme Australia Pty Limited, South Granville, New South Wales, Australia

Dated this 10th day of October 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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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 142


Gazette.govt.nz PDF NZ Gazette 2001, No 142





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a New Related Product

πŸ₯ Health & Social Welfare
10 October 2001
Medicines Act 1981, New Related Product, Consent, Distribution, Macleans Multi-Action + Whitening, Macleans Whitening Fresh, Macleans Whitening, Sodium fluoride, Oral paste, SmithKline Beecham (NZ) Limited, GlaxoSmithKline Australia Pty Limited
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
10 October 2001
Medicines Act 1981, Changed Medicines, Consent, Distribution, Dysport, Clostridium botulinum type A toxin haemagglutinin complex, Powder for injection, New Zealand Medical & Scientific Limited, Ipsen Limited, Vioxx, Rofecoxib, Oral suspension, Tablet, Merck Sharp & Dohme (New Zealand) Limited, Merck & Co Inc, Merck Manufacturing Division
  • G. R. Boyd, Chief Advisor, Safety and Regulation