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: Anaccord
Active Ingredient: Anastrozole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Accord Healthcare NZ Limited
Manufacturer: Intas Pharmaceuticals Limited, Gujarat, India
Product: Arrow - Cilazapril 1
Active Ingredient: Cilazapril monohydrate 1.043mg equivalent to 1.0mg cilazpril
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Arrow - Cilazapril 2.5
Active Ingredient: Cilazapril monohydrate 2.608mg equivalent to 2.5mg cilazapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Arrow - Cilazapril 5
Active Ingredient: Cilazapril monohydrate 5.216mg equivalent to 5.0mg cilazapril
Dosage Form: Film coated tablet
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Cobalt Pharmaceuticals Inc., Ontario, Canada
Product: Clavicin
Active Ingredients: Amoxicillin trihydrate 575mg equivalent to amoxicillin 500mg
Potassium clavulanate 149mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Medreich Limited, Bangalore, India
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 172.69mg equivalent to 150mg quetiapine as free base
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturer: AstraZeneca UK Limited, Macclesfield, United Kingdom
Dated this 1st day of April 2010.
ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).