Zemfirza: Withdrawal of the marketing authorisation application

cediranib

Overview

On 19 September 2016, AstraZeneca AB officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zemfirza, for the treatment of ovarian cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Zemfirza (cediranib) (PDF/76.5 KB)


    First published: 14/10/2016
    Last updated: 14/10/2016
    EMA/656265/2016

  • Key facts

    Name
    Zemfirza
    Product number
    EMEA/H/C/004003
    International non-proprietary name (INN) or common name
    • cediranib
    Active substance
    • cediranib maleate
    Date of withdrawal
    19/09/2016
    Company making the application
    AstraZeneca AB
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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