Doxorubicin SUN: Withdrawal of the marketing authorisation application

doxorubicin

Overview

On 20 Jul 2011, 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 Doxorubicin SUN, intended for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma.

  • List item

    Withdrawal of the marketing authorisation application for Doxorubicin SUN (PDF/55.43 KB)


    First published: 13/09/2011
    Last updated: 13/09/2011
    EMA/CHMP/647763/2011

  • Key facts

    Name
    Doxorubicin SUN
    Product number
    EMEA/H/C/002049
    International non-proprietary name (INN) or common name
    • doxorubicin
    Active substance
    • doxorubicin hydrochloride
    Date of withdrawal
    20/07/2011
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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