Withdrawal of the marketing authorisation application



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.

Key facts

Product number
International non-proprietary name (INN) or common name
  • enasidenib
Active substance
  • Enasidenib mesilate
Date of withdrawal
Company making the application
Celgene Europe BV
Withdrawal type
Initial authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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