Docetaxel Mylan: Withdrawal of the marketing authorisation application



On 8 March 2010, Mylan S.A.S. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Docetaxel Mylan (docetaxel) (PDF/51.32 KB)

    First published: 26/03/2010
    Last updated: 26/03/2010

  • Key facts

    Docetaxel Mylan
    Product number
    International non-proprietary name (INN) or common name
    • docetaxel
    Active substance
    • docetaxel
    Date of withdrawal
    Company making the application
    Mylan S.A.S.
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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