Begedina: Withdrawal of the marketing authorisation application

begelomab

Overview

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
    EMA/491291/2016

  • Key facts

    Name
    Begedina
    Product number
    EMEA/H/C/004144
    International non-proprietary name (INN) or common name
    • begelomab
    Active substance
    • begelomab
    Date of withdrawal
    04/07/2016
    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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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