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.
Treatment of Lennox-Gastaut syndrome
|Orphan designation status||
|EU designation number||
|Date of designation||
Documents related to this orphan designation evaluation
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: