Topotecan SUN: Withdrawal of the marketing authorisation application

topotecan

Overview

On 3 January 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 Topotecan SUN for the treatment metastatic cancer of the ovary, small cell lung cancer and cervical cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Topotecan SUN (PDF/66.59 KB)


    First published: 23/02/2011
    Last updated: 23/02/2011
    EMA/121971/2011

  • Key facts

    Name
    Topotecan SUN
    Product number
    EMEA/H/C/002091
    International non-proprietary name (INN) or common name
    • topotecan
    Active substance
    • topotecan
    Date of withdrawal
    03/01/2011
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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