Idhifa: Withdrawal of the marketing authorisation application

enasidenib

Overview

Celgene Europe B.V. withdrew its application for a marketing authorisation of Idhifa for the treatment of adults with acute myeloid leukaemia (AML), a cancer of white blood cells.

The company withdrew the application on 6 December 2019.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Idhifa (enasidenib) (PDF/117.94 KB)


    First published: 31/01/2020
    EMA/47029/2020

  • Key facts

    Name
    Idhifa
    Product number
    EMEA/H/C/004324
    International non-proprietary name (INN) or common name
    • enasidenib
    Active substance
    • Enasidenib mesilate
    Date of withdrawal
    06/12/2019
    Company making the application
    Celgene Europe BV
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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