Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicines set out in the Schedule hereto:
Schedule
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Indiana, United States of America
Note: This renewed consent is valid for two years from 23 March 2010.
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Indiana, United States of America
Note: This renewed consent is valid for two years from 23 March 2010.
Product: Tarceva
Active Ingredient: Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturers: F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Indiana, United States of America
Note: This renewed consent is valid for two years from 23 March 2010.
Dated this 5th day of February 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).