EU/3/15/1510: Orphan designation for the treatment of amyotrophic lateral sclerosis

edaravone

Overview

On 19 June 2015, orphan designation (EU/3/15/1510) was granted by the European Commission to Mitsubishi Tanabe Pharma Europe Ltd, United Kingdom, for edaravone for the treatment of amyotrophic lateral sclerosis.

The sponsorship was transferred to Mitsubishi Tanabe Pharma GmbH, Germany, in March 2019.

Key facts

Active substance
edaravone
Medicine name
-
Intended use
Treatment of amyotrophic lateral sclerosis
Orphan designation status
Positive
EU designation number
EU/3/15/1510
Date of designation
19/06/2015
Sponsor

Mitsubishi Tanabe Pharma GmbH
Schiessstrasse 47
Heerdt
North Rhine-Westphalia
40549 Duesseldorf
Germany
Tel: +49 (0)211 52054 40
E-mail: regulatory@mt-pharma-eu.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Update history

DateUpdate
July 2023The sponsor’s address was updated in July 2023.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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