Begedina: Withdrawal of the marketing authorisation application


On 4 July 2016, Adienne S.r.l. S.U. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Begedina, for the treatment of graft-versus-host disease.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Begedina (begelomab) (PDF/73.84 KB)

    First published: 22/07/2016
    Last updated: 17/01/2017

  • Key facts

    Product number
    Active substance
    • begelomab
    Date of withdrawal
    Company making the application
    Adienne S.r.l. S.U.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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