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: Asacol
Active Ingredient: Mesalazine 800mg
Dosage Form: Enteric coated tablet
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Wulfing Pharma GmbH Gronau/Leine, Germany
Product: Axetine
Active Ingredient: Cefuroxime sodium 1.652g equivalent to 1.5g cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Ayios, Athanasios, Lemesos, Cyprus
Product: Axetine
Active Ingredient: Cefuroxime sodium 275mg equivalent to 250mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Ayios, Athanasios, Lemesos, Cyprus
Product: Axetine
Active Ingredient: Cefuroxime sodium 826mg equivalent to 750mg cefuroxime
Dosage Form: Powder for injection
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Medochemie Limited, Ayios, Athanasios, Lemesos, Cyprus
Product: Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 1,164.8mg equivalent to 1g ceftazidime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Biochemie GmbH, Kundl, Austria
Product: Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 2,329.6mg equivalent to 2 g ceftazidime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Biochemie GmbH, Kundl, Austria
Product: Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 291.2mg equivalent to 250mg ceftazidime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Biochemie GmbH, Kundl, Austria
Product: Ceftazidime
Active Ingredient: Ceftazidime pentahydrate 582.4mg equivalent to 500mg ceftazidime
Dosage Form: Powder for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Biochemie GmbH, Kundl, Austria
Product: Lumigan
Active Ingredient: Bimatoprost 0.3mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: Allergan New Zealand Limited
Manufacturers: Allergan Inc. Waco, Texas, United States of America
Allergan Pharmaceuticals (Ireland) Limited, Westport, County Mayo, Ireland
Product: Panadol Rapid
Active Ingredient: Paracetamol 500mg
Dosage Form: Film coated tablet
New Zealand Sponsor: SmithKline Beecham (NZ) Limited
Manufacturer: GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan, Co. Waterford, Ireland
Product: Patanol Eye Drops
Active Ingredient: Olopatadine hydrochloride 0.111%w/v equivalent to 0.1%w/v olopatadine
Dosage Form: Eye drops, solution
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer: Alcon Couvreur SA, Puurs, Belgium
Product: Risperdal Consta
Active Ingredient: Risperidone 25mg
Dosage Form: Vial Powder for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Product: Risperdal Consta
Active Ingredient: Risperidone 37.5mg
Dosage Form: Vial Suspension for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Product: Risperdal Consta
Active Ingredient: Risperidone 50mg
Dosage Form: Vial Suspension for injection
New Zealand Sponsor: Janssen-Cilag Pty Limited
Manufacturer: Alkermes, Wilmington, Ohio, United States of America
Dated this 7th day of August 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).