Docetaxel Zentiva (previously Docetaxel Winthrop): Withdrawal of the application to change the marketing authorisation
On 14 November 2008, Sanofi-Aventis Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Taxotere/Docetaxel Winthrop, to add the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Docetaxel Zentiva (previously Docetaxel Winthrop)
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Docetaxel Winthrop (PDF/990.92 KB)Adopted
First published: 25/11/2008
Last updated: 25/11/2008
Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for Taxotere and Docetaxel Winthrop (docetaxel) (PDF/31.09 KB)
First published: 17/11/2008
Last updated: 17/11/2008
Withdrawal letter : Docetaxel Winthrop (PDF/24.35 KB)
First published: 14/11/2008
Last updated: 14/11/2008
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Taxotere/Docetaxel Winthrop (PDF/39.65 KB)
First published: 20/11/2008
Last updated: 20/11/2008
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').