Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed medicine which was referred to the Minister of Health under the provisions of section 24(5) and is set out in the Schedule hereto:
Schedule
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg
Dosage Form: Tablet Film coated
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form: Tablet Film coated
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg
Dosage Form: Tablet Film coated
New Zealand Sponsor: Roche Products (New Zealand) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America
Dated this 3rd day of June 2008.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).