EU/3/04/240: Orphan designation for the treatment of Lennox-Gastaut syndrome


Table of contents


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in January 2019 at the end of the 12-year period of market exclusivity.

On 20 October 2004, orphan designation (EU/3/04/240) was granted by the European Commission to Eisai Limited, United Kingdom, for rufinamide for the treatment of Lennox-Gastaut syndrome.

Rufinamide has been authorised in the EU as Inovelon since 16 January 2007.

The sponsorship was transferred to Eisai GmbH - Germany, in June 2018.

Key facts

Active substance
Intended use
Treatment of Lennox-Gastaut syndrome
Orphan designation status
EU designation number
Date of designation
Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main

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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