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).

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

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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