✨ Health Notices




NEW ZEALAND GAZETTE, No. 124

23 SEPTEMBER 2004

Health

Medicines Act 1981

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:
Gonal-f Multidose for injection

Active Ingredient:
Follitropin alpha 1,050IU equiv to 76.44Β΅g retrievable dose

Dosage Form:
Powder for injection

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Industria Farmaceutica Serono SpA, Via de Blasio, Zone Industriale di Modugno, Bari, Italy

Product:
Gonal-f Multidose for Injection

Active Ingredient:
Follitropin alpha 450IU equiv to 32.76Β΅g retrievable dose

Dosage Form:
Powder for injection

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Industria Farmaceutica Serono SpA, Zone Industriale di Modugno, Bari, Italy

Product:
Sonata

Active Ingredient:
Zaleplon 10mg

Dosage Form:
Capsule

New Zealand Sponsor:
Wyeth (NZ) Limited

Manufacturer:
Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico

Product:
Sonata

Active Ingredient:
Zaleplon 5mg

Dosage Form:
Capsule

New Zealand Sponsor:
Wyeth (NZ) Limited

Manufacturer:
Wyeth Pharmaceuticals Company, Barrios Pozo Hondos & Jobos, Guayama, Puerto Rico

Product:
Xolair

Active Ingredient:
Omalizumab 150mg

Dosage Form:
Powder for injection

New Zealand Sponsor:
Novartis New Zealand Limited

Manufacturer:
Genentech Inc, South San Francisco, California, United States of America

Dated this 17th day of September 2004.

GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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:
Botox

Active Ingredient:
Botulinum A toxin 100U

Dosage Form:
Powder for injection

New Zealand Sponsor:
Allergan New Zealand Limited

Manufacturers:
Allergan Berkeley, Berkeley, California, United States of America
Allergan Pharmaceuticals Ireland, Westport, County Mayo, Eire
Charles River Laboratories Biolabs Europe, Carrentrila, Ballina, County Mayo, Eire
Northview Pacific Labs, Berkeley, California, United States of America

Dated this 17th day of September 2004.

GRAEME GILLESPIE, Acting Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2004, No 124


Gazette.govt.nz PDF NZ Gazette 2004, No 124





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
17 September 2004
Medicines Act 1981, New Medicines, Distribution Consent, Gonal-f, Sonata, Xolair
  • Graeme Gillespie, Acting Deputy Director-General, Public Health

πŸ₯ Consent to the Distribution of a Changed Medicine

πŸ₯ Health & Social Welfare
17 September 2004
Medicines Act 1981, Changed Medicine, Distribution Consent, Botox
  • Graeme Gillespie, Acting Deputy Director-General, Public Health