Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicines which were referred to the Minister of Health under the provisions of section 24 (5) of the Act and are set out in the Schedule hereto:
Schedule
Product: Oxis Turbuhaler
Active Ingredient: Formoterol fumarate 12Ág/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Oxis Turbuhaler
Active Ingredient: Formoterol fumarate 6Ág/dose
Dosage Form: Powder for inhalation
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca AB, Sodertalje, Sweden
Product: Tequin
Active Ingredient: Gatifloxacin 2mg/mL
Dosage Form: Solution for infusion
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Abbott Laboratories Inc, North Chicago, Illinois, United States of America
Product: Tequin
Active Ingredient: Gatifloxacin 10mg/mL
Dosage Form: Concentrate for injection
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Caribbean Inc, Mayaguez, Puerto Rico
Product: Tequin
Active Ingredient: Gatifloxacin 200mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Puerto Rico Inc., Humacao, Puerto Rico
Product: Tequin
Active Ingredient: Gatifloxacin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Puerto Rico Inc., Humacao, Puerto Rico
Product: Tequin
Active Ingredient: Gatifloxacin 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Bristol-Myers Squibb (NZ) Company
Manufacturer: Bristol-Myers Squibb Puerto Rico Inc., Humacao, Puerto Rico
Dated this 16th day of January 2003.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).