Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg
Dosage Form: Film coated tablet
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
Note: This consent is valid for two years from 23 March 2008.
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form: Film coated tablet
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
Note: This consent is valid for two years from 23 March 2008.
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg.
Dosage Form: Film coated tablet
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
Note: This consent is valid for two years from 23 March 2008.
Dated this 17th day of March 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).