Radicava: Withdrawal of the marketing authorisation application

edaravone

Overview

On 24 May 2019, Mitsubishi Tanabe Pharma GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of amyotrophic lateral sclerosis (ALS).

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Radicava (edaravone) (PDF/76.89 KB)


    First published: 29/05/2019
    EMA/293450/2019

  • Key facts

    Name
    Radicava
    Product number
    EMEA/H/C/004938
    International non-proprietary name (INN) or common name
    • edaravone
    Active substance
    • edaravone
    Date of withdrawal
    24/05/2019
    Company making the application
    Mitsubishi Tanabe Pharma 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 (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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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