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: Apo-Ibuprofen
Active Ingredient(s): Ibuprofen 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer(s): Apotex Inc, Weston, Ontario, Canada
Product: Cipflox
Active Ingredient(s): Ciprofloxacin hydrochloride 277.5mg equivalent to 250mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Pharmaceuticals, Etobicoke, Ontario, Canada
Product: Cipflox
Active Ingredient(s): Ciprofloxacin hydrochloride 555mg equivalent to 500mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Pharmaceuticals, Etobicoke, Ontario, Canada
Product: Cipflox
Active Ingredient(s): Ciprofloxacin hydrochloride 832.5mg equivalent to 750mg ciprofloxacin
Dosage Form: Film coated tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Pharmaceuticals, Etobicoke, Ontario, Canada
Product: Nicorette Inhaler
Active Ingredient(s): Nicotine 15mg
Dosage Form: Volatile liquid for inhalation
New Zealand Sponsor: Pharmacia Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia AB, Consumer Healthcare, Helsingborg, Sweden
Product: Robitussin Honey Cough Syrup
Active Ingredient(s): Dextromethorphan hydrobromide 2mg/mL
Dosage Form: Syrup
New Zealand Sponsor: Whitehall Consumer Healthcare (NZ) Limited
Manufacturer(s): Whitehall-Robins, Richmond, Virginia, United States of America
Product: Tequin
Active Ingredient(s): Gatifloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Abbott Laboratories Inc., North Chicago, Illinois, United States of America
Product: Tequin
Active Ingredient(s): Gatifloxacin 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Caribbean Inc., Mayaguez, Puerto Rico
Product: Tequin
Active Ingredient(s): Gatifloxacin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Puerto Rico Inc., Squibb Manufacturing Inc., Humacao, Puerto Rico
Product: Tequin
Active Ingredient(s): Gatifloxacin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Limited
Manufacturer(s): Bristol-Myers Squibb Puerto Rico Inc., Squibb Manufacturing Inc., Humacao, Puerto Rico
Dated this 11th day of July 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).