✨ Medicines Consent Notices




NEW ZEALAND GAZETTE

No. 149

Renewal of 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 medicines set out in the Schedule hereto:

Schedule

Product:
Viracept

Active Ingredient(s):
Nelfinavir mesylate 58.5mg/g equivalent 50 mg/g nelfinavir free base

Dosage Form:
Powder for oral suspension

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturer(s):
F Hoffmann-La Roche AG, Basel, Switzerland

Note: This consent is valid for 2 years from the 12th February 2002.

Product:
Viracept

Active Ingredient(s):
Nelfinavir mesylate 292.25mg equivalent 250 mg nelfinavir free base

Dosage Form:
Tablet

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturer(s):
F Hoffmann-La Roche AG, Basel, Switzerland
Mova Pharmaceutical Corporation, Villa Blanca Industrial Park, Caguas, Puerto Rico
Productos Roche S.A., Leganes (Madrid), Spain

Note: This consent is valid for 2 years from the 12th February 2002.

Dated this 24th 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 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:
Cipflox

Active Ingredient(s):
Ciprofloxacin hydrochloride 111mg equivalent to 100mg ciprofloxacin

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Pacific Pharmaceuticals Limited

Manufacturer(s):
Genpharm Inc., Etobicoke, Ontario, Canada

Product:
Uprima SL

Active Ingredient(s):
Apomorphine hydrochloride (hemihydrate) 2mg

Dosage Form:
Sublingual tablet

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer(s):
Abbott Laboratories Inc, Abbott Park, Illinois, United States of America
Abbott Laboratories Limited, Queenborough, Kent, United Kingdom
Oread Pharmaceutical Manufacturing, Palo Alto, California, United States of America

Product:
Uprima SL

Active Ingredient(s):
Apomorphine hydrochloride (hemihydrate) 3mg

Dosage Form:
Sublingual tablet

New Zealand Sponsor:
Abbott Laboratories (NZ) Limited

Manufacturer(s):
Abbott Laboratories Inc, Abbott Park, Illinois, United States of America
Abbott Laboratories Limited, Queenborough, Kent, United Kingdom
Oread Pharmaceutical Manufacturing, Palo Alto, California, United States of America

Product:
Zyvox

Active Ingredient(s):
Linezolid 20mg/mL

Dosage Form:
Granules for oral suspension

New Zealand Sponsor:
Pharmacia Limited Company trading as Pharmacia

Manufacturer(s):
Pharmacia Inc, Barcelonetta, Puerto Rico

Product:
Zyvox

Active Ingredient(s):
Linezolid 2mg/mL

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Pharmacia Limited Company trading as Pharmacia

Manufacturer(s):
Fresenius Kabi Norge AS, Berg I Ostfold, Halden, Norway

Product:
Zyvox

Active Ingredient(s):
Linezolid 400mg

Dosage Form:
Film coated tablet



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2001, No 149


Gazette.govt.nz PDF NZ Gazette 2001, No 149





✨ LLM interpretation of page content

πŸ₯ Renewal of Provisional Consent to Distribution of Viracept

πŸ₯ Health & Social Welfare
24 October 2001
Medicines, Provisional Consent, Viracept, Nelfinavir mesylate
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Consent, Cipflox, Uprima SL, Zyvox