EU/3/01/071: Orphan designation for the treatment of severe myoclonic epilepsy in infancy


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2017 at the end of the period of market exclusivity.

On 5 December 2001 orphan designation (EU/3/01/071) was granted by the European Commission to Biocodex, France, for stiripentol for the treatment of severe myoclonic epilepsy in infancy.

Stiripentol has been authorised in the EU as Diacomit since 4 January 2007.

Key facts

Active substance
Medicine name
Intended use
Treatment of severe myoclonic epilepsy in infancy
Orphan designation status
EU designation number
Date of designation
7 avenue Gallieni
94257 Gentilly
Telephone: +33 1 41 24 30 00
Telefax : +33 1 41 24 30 01

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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