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: Diamicron MR
Active Ingredient(s): Gliclazide 30mg
Dosage Form: Modified release tablet
New Zealand Sponsor: Servier Laboratories Limited
Manufacturer(s): Les Laboratoires Servier Industrie, Gidy, France
Servier (Ireland) Industries Limited, Arklow, County Wicklow, Ireland
Product: Edronax
Active Ingredient(s): Reboxetine mesylate 2.612mg equivalent to 2mg reboxetine free base
Dosage Form: Tablet
New Zealand Sponsor: Pharmacia & Upjohn Limited Company (trading as Pharmacia)
Manufacturer(s): Pharmacia & Upjohn SpA, Marino del Tronto, Ascoli Piceno, Italy
Product: Edronax
Active Ingredient(s): Reboxetine mesylate 5.224mg equivalent to 4mg reboxetine free base
Dosage Form: Tablet
New Zealand Sponsor: Pharmacia & Upjohn Limited Company trading as Pharmacia
Manufacturer(s): Pharmacia & Upjohn SpA, Marino del Tronto, Ascoli Piceno, Italy
Product: Ethyol
Active Ingredient(s): Amifostine 375mg
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Ben Venue Laboratories Inc, Bedford, Ohio, United States of America
MedImmune Pharma BV, Nijmegen, The Netherlands
Product: Hexalen
Active Ingredient(s): Altretamine 50mg
Dosage Form: Capsule
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Applied Analytical Industries Inc., Wilmington, North Carolina, United States of America
Heumann Pharma GmbH, Feucht, Germany
Product: Microgynon 20
Active Ingredient(s): Levonorgestrel 100µg
Ethinyloestradiol 20µg
Dosage Form: Tablet
New Zealand Sponsor: Schering (NZ) Limited
Manufacturer(s): Schering AG, Wedding Plant, Berlin, Germany
Schering GmbH und Co Produktions KG, Weimar, Germany
Product: Remicade
Active Ingredient(s): Infliximab 100mg
Dosage Form: Powder for injection
New Zealand Sponsor: Schering-Plough Pty Limited
Manufacturer(s): Parkedale Pharmaceuticals Inc, Rochester, Michigan, United States of America
Product: Tobi
Active Ingredient(s): Tobramycin 60mg/mL
Dosage Form: Solution for inhalation
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer(s): Automatic Liquid Packaging Inc, Woodstock, Illinois, United States of America
Product: Vesanoid
Active Ingredient(s): Tretinoin 10mg
Dosage Form: Liquid filled capsule
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturer(s): R P Scherer GmbH, Eberbach/Baden, Germany
Dated this 8th day of November 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).