Factive: Withdrawal of the marketing authorisation application

gemifloxacin

Overview

On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, community-acquired pneumonia and acute exacerbation of chronic bronchitis.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Factive (gemifloxacin) (PDF/38.19 KB)


    First published: 01/07/2009
    Last updated: 01/07/2009
    EMEA/409402/2009

  • Key facts

    Name
    Factive
    Product number
    EMEA/H/C/000995
    International non-proprietary name (INN) or common name
    • gemifloxacin
    Active substance
    • gemifloxacin
    Date of withdrawal
    17/06/2009
    Company making the application
    Menarini International Operations Luxembourg S.A.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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