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: Estradot
Active Ingredient: Oestradiol hemihydrate 1.56mg equivalent to 100Ág per 24 hours
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estradot
Active Ingredient: Oestradiol hemihydrate 0.585mg equivalent 37.5Ág per 24 hours
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estradot
Active Ingredient: Oestradiol hemihydrate 0.78mg equivalent to 50Ág per 24 hours
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Estradot
Active Ingredient: Oestradiol hemihydrate 1.17mg equivalent to 75Ág per 24 hours
Dosage Form: Transdermal patch, systemic effect
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Noven Pharmaceuticals Inc, Miami, Florida, United States of America
Product: Travatan 0.0015 % Eye Drops
Active Ingredient: Travoprost 15Ág/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alcon Couvreur SA, Puurs, Belgium
Product: Travatan 0.004% Eye Drops
Active Ingredient: Travoprost 40Ág/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alcon Couvreur SA, Puurs, Belgium
Product: Xeloda
Active Ingredient: Capecitabine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited (trading as Roche Consumer Health), Welwyn Garden City, Hertfordshire, United Kingdom
Product: Xeloda
Active Ingredient: Capecitabine 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): Hoffmann-La Roche Inc, Nutley, New Jersey, United States of America
Roche Products Limited (trading as Roche Consumer Health), Welwyn Garden City, Hertfordshire, United Kingdom
Dated this 4th day of February 2002.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).