Docetaxel SUN: Withdrawal of the marketing authorisation application

docetaxel

Overview

On 6 June 2016, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Sun, for the treatment of various types of cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Docetaxel Sun (docetaxel) (PDF/73.51 KB)


    First published: 24/06/2016
    Last updated: 24/06/2016
    EMA/396891/2016

  • Key facts

    Name
    Docetaxel SUN
    Product number
    EMEA/H/C/004086
    International non-proprietary name (INN) or common name
    • docetaxel
    Active substance
    • anhydrous docetaxel
    Date of withdrawal
    06/06/2016
    Company making the application
    Sun Pharmaceutical Industries Europe B.V.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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