β¨ 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 —
NZ Gazette 2001, No 149
Gazette.govt.nz —
NZ Gazette 2001, No 149
β¨ LLM interpretation of page content
π₯ Renewal of Provisional Consent to Distribution of Viracept
π₯ Health & Social Welfare24 October 2001
Medicines, Provisional Consent, Viracept, Nelfinavir mesylate
- G. R. Boyd, Chief Advisor, Safety and Regulation
π₯ Consent to Distribution of New Medicines
π₯ Health & Social WelfareMedicines, Consent, Cipflox, Uprima SL, Zyvox