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-Amisulpride
Active Ingredient: Amisulpride 50mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Product: Apo-Amisulpride
Active Ingredient: Amisulpride 100mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Product: Apo-Amisulpride
Active Ingredient: Amisulpride 200mg
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Product: Apo-Amisulpride
Active Ingredient: Amisulpride 400mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Rivopharm SA, Manno, Switzerland
Product: Cromo-Fresh
Active Ingredient: Sodium cromoglicate 20mg/mL
Dosage Form: Eye drops, solution
New Zealand Sponsor: AFT Pharmaceuticals Limited
Manufacturer: Ursapharm Arzneimittel GmbH, Saarbrucken, Germany
Product: m-Clopidogrel
Active Ingredient: Clopidogrel besilate 112.1mg equivalent to Clopidogrel 75mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Multichem NZ Limited
Manufacturers: Pharmathen SA, Attiki, Greece
Boehringer Ingelheim Ellas A E, Koropi, Greece
Pharmathen International S A, Rodopi, Greece
Product: Ristova
Active Ingredient: Rituximab 10mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: Roche Diagnostics GmbH, Mannheim, Germany
F Hoffmann-La Roche Limited, Basel, Switzerland
Genentech Inc, California, United States of America
Dated this 8th day of October 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).