Balimek: Withdrawal of the marketing authorisation application



On 4 January 2018, Pierre Fabre Médicament officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Balimek, for the treatment of melanoma.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Balimek (binimetinib) (PDF/73.87 KB)

    First published: 26/01/2018
    Last updated: 27/03/2018

  • Key facts

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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