EU/3/19/2134: Orphan designation for the treatment of infantile neuroaxonal dystrophy

9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester

Table of contents

Overview

On 26 February 2019, orphan designation (EU/3/19/2134) was granted by the European Commission to FGK Representative Service GmbH, Germany for 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester (also known as RT001) for the treatment of infantile neuroaxonal dystrophy.

Key facts

Active substance
9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester
Intended use
Treatment of infantile neuroaxonal dystrophy
Orphan designation status
Positive
EU designation number
EU/3/19/2134
Date of designation
26/02/2019
Sponsor

FGK Representative Service GmbH
Heimeranstrasse 35
80339 Munich
Germany
Bavaria
Tel.+49 8989 311928
E-mail: clinical.studies@fgk-rs.com

Documents related to this orphan designation evaluation

Patients' organisations

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

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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