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
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia Inc, Barcelonetta, Puerto Rico
Product: Zyvox
Active Ingredient(s): Linezolid 600mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia Inc, Barcelonetta, Puerto Rico
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).