Topotecan SUN: Withdrawal of the marketing authorisation application



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

  • Key facts

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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