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: Anastrozole
Active Ingredient: Anastrozole 1mg
Dosage Form: Film coated tablet
New Zealand Sponsor: REX Medical Limited
Manufacturer: Cipla Limited, Goa, India
Product: Diovan
Active Ingredient: Valsartan 320mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland
Product: Gammanorm
Active Ingredient: Normal immunoglobulin 165mg
Dosage Form: Solution for injection
New Zealand Sponsor: Octapharma New Zealand Limited
Manufacturer: Octapharma AB, Stockholm, Sweden
Product: Polaramine Colour-Free
Active Ingredient: Dexchlorpheniramine maleate 2mg
Dosage Form: Tablet
New Zealand Sponsor: Schering-Plough a division of Schering-Plough Animal Health Limited
Manufacturer: Schering-Plough Laboratories NV, Belgium
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 230.26mg equivalent to quetiapine free base 200mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Silk Macclesfield, Cheshire, United Kingdom
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 345.38mg equivalent to quetiapine free base 300mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Macclesfield, Cheshire, United Kingdom
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 460.5mg equivalent to quetiapine free base 400mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Macclesfield, Cheshire, United Kingdom
Product: Seroquel XR
Active Ingredient: Quetiapine fumarate 57.56mg equivalent to quetiapine free base 50mg
Dosage Form: Modified release tablet
New Zealand Sponsor: AstraZeneca Limited
Manufacturers: AstraZeneca Pharmaceuticals LP, Newark, Delaware, United States of America
AstraZeneca UK Ltd, Macclesfield, Cheshire, United Kingdom
Product: Sumatriptan
Active Ingredient: Sumatriptan succinate 140mg equivalent to 100mg sumatriptan
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Andhra Pradesh, India
Product: Sumatriptan
Active Ingredient: Sumatriptan succinate 70mg equivalent to 50mg sumatriptan
Dosage Form: Film coated tablet
New Zealand Sponsor: Affordable Healthcare Limited
Manufacturer: Dr Reddy’s Laboratories Limited, Generics, Andhra Pradesh, India
Dated this 16th day of June 2008.
ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).