EU/3/18/2017: Orphan designation for the treatment of amyotrophic lateral sclerosis
Ambroxol hydrochloride
Table of contents
Overview
On 25 May 2018, orphan designation (EU/3/18/2017) was granted by the European Commission to Spedding Research Solutions SAS, France, for ambroxol hydrochloride for the treatment of amyotrophic lateral sclerosis.
Key facts
Active substance |
Ambroxol hydrochloride
|
Intended use |
Treatment of amyotrophic lateral sclerosis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/18/2017
|
Date of designation |
25/05/2018
|
Sponsor |
Spedding Research Solutions SAS
6 rue Ampère 78110 Le Vésinet France Tel. +33637059188 E-mail: michael@speddingresearchsolutions.fr |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
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: