Balimek: Withdrawal of the marketing authorisation application

binimetinib

Overview

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
    EMA/41972/2018

  • Key facts

    Name
    Balimek
    Product number
    EMEA/H/C/004052
    International non-proprietary name (INN) or common name
    • binimetinib
    Active substance
    • binimetinib
    Date of withdrawal
    04/01/2018
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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