EU/3/14/1399: Orphan designation for the treatment of amyotrophic lateral sclerosis

edaravone

Overview

On 16 December 2014, orphan designation (EU/3/14/1399) was granted by the European Commission to Treeway B.V., the Netherlands, for edaravone for the treatment of amyotrophic lateral sclerosis.

Key facts

Active substance
edaravone
Intended use
Treatment of amyotrophic lateral sclerosis
Orphan designation status
Positive
EU designation number
EU/3/14/1399
Date of designation
16/12/2014
Sponsor

Ferrer Internacional S.A.
Gran Via De Carles III 94
08028 Barcelona
Spain
Email: csastre@ferrer.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
December 2022The sponsor's address was updated.
March 2023The sponsorship was transferred from Treeway B.V.,The Netherlands to Ferrer Internacional S.A.

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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