EU/3/15/1459: Orphan designation for the treatment of amyotrophic lateral sclerosis
Enoxacin
Table of contents
Overview
On 19 March 2015, orphan designation (EU/3/15/1459) was granted by the European Commission to Impasara Ltd, United Kingdom, for enoxacin for the treatment of amyotrophic lateral sclerosis.
The sponsorship was transferred to Dr. Regenold GmbH, Germany, in October 2015.
In July 2017, Dr. Regenold GmbH Development Regulatory Market Access changed name to Dr. Regenold GmbH.
The sponsor's name was updated in September 2021.
Key facts
Active substance |
Enoxacin
|
Intended use |
Treatment of amyotrophic lateral sclerosis
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/15/1459
|
Date of designation |
19/03/2015
|
Sponsor |
Regenold GmbH |
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:
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: