Docetaxel Mylan: Withdrawal of the marketing authorisation application

docetaxel

Overview

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
    EMA/166011/2010

  • Key facts

    Name
    Docetaxel Mylan
    Product number
    EMEA/H/C/001193
    International non-proprietary name (INN) or common name
    • docetaxel
    Active substance
    • docetaxel
    Date of withdrawal
    08/03/2010
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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