orBec: Withdrawal of the marketing authorisation application

beclomethasone dipropionate

Overview

On 22 May 2008, DOR BIOPHARMA UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for orBec, for the treatment of gastrointestinal graft-versus-host disease. orBec was designated as an orphan medicinal product on 13 March 2002.

  • List item

    Questions and answers on the withdrawal of the marketing application for orBec (PDF/34.98 KB)


    First published: 05/06/2008
    Last updated: 05/06/2008
    EMEA/266786/2008

  • Key facts

    Name
    orBec
    Product number
    EMEA/H/C/000803
    International non-proprietary name (INN) or common name
    • beclomethasone dipropionate
    Date of withdrawal
    22/05/2008
    Company making the application
    DOR BIOPHARMA UK Ltd
    Withdrawal type
    Initial authorisation

    All documents

    Related content

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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