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.

  • List item

    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

  • Key facts

    Docetaxel Zentiva (previously Docetaxel Winthrop)
    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • docetaxel
    Active substance
    • docetaxel
    Date of withdrawal
    Company making the application
    Zentiva k.s.
    Withdrawal type

    All documents

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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