EU/3/13/1194: Orphan designation for the treatment of Duchenne muscular dystrophy



Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in December 2017 on request of the sponsor.

On 7 October 2013, orphan designation (EU/3/13/1194) was granted by the European Commission to Nicox, France, for naproxcinod for the treatment of Duchenne muscular dystrophy.

Key facts

Active substance
Intended use
Treatment of Duchenne muscular dystrophy
Orphan designation status
EU designation number
Date of designation
Nicox S.A.
Drakkar 2- Bat D
2405 route des Dolines
CS 10313 Sophia Antipolis
06560 Valbonne
Tel. +33 6972 45300
Fax +33 6972 45309

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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:

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