Raxone:

Withdrawal of the marketing authorisation application

idebenone

Overview

On 21 March 2013, Santhera Pharmaceuticals (Deutschland) GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Raxone, for the treatment of Leber's hereditary optic neuropathy (LHON).

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Raxone (PDF/76.88 KB)


    First published: 26/04/2013
    Last updated: 26/04/2013
    EMA/242206/2013

  • Key facts

    Name
    Raxone
    Product number
    EMEA/H/C/002425
    International non-proprietary name (INN) or common name
    • idebenone
    Active substance
    • idebenone
    Date of withdrawal
    21/03/2013
    Company making the application
    Santhera Pharmaceuticals (Deutschland) GmbH
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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