EU/3/04/189: Orphan designation for the treatment of Friedreich's ataxia


Table of contents


On 8 March 2004, orphan designation (EU/3/04/189) was granted by the European Commission to Promedipharm GmbH, Germany, for idebenone for the treatment of Friedreich's ataxia.

The sponsorship was transferred to Santhera Pharmaceuticals (Deutschland) AG in December 2005.

The name of the sponsor changed to Santhera Pharmaceuticals (Deutschland) GmbH in September 2010.

Key facts

Active substance
Intended use
Treatment of Friedreich's ataxia
Orphan designation status
EU designation number
Date of designation

Santhera Pharmaceuticals (Deutschland) GmbH
Marie-Curie Strasse 8
D-79539 Lörrach
Tel. +49 7621 1690200
Fax +49 7621 1690201

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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