EU/3/14/1399: Orphan designation for the treatment of amyotrophic lateral sclerosis
edaravone
Table of contents
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. |
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
Date | Update |
---|---|
December 2022 | The sponsor's address was updated. |
March 2023 | The sponsorship was transferred from Treeway B.V.,The Netherlands to Ferrer Internacional S.A. |
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: