On 15 October 2014, orphan designation (EU/3/14/1339) was granted by the European Commission to GW Pharma Ltd, United Kingdom, for cannabidiol for the treatment of Dravet syndrome.
Cannabidiol treatment of Dravet syndrome and treatment of Lennox-Gastaut has been authorised in the EU as Epidyolex since 19 September 2019.
Treatment of Dravet syndrome
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|November 2017||The sponsorship was transferred to GW Research Ltd, United Kingdom.|
|April 2019||The sponsorship was transferred to GW Pharma (International) B.V., the Netherlands.|
|June 2023||The sponsorship was transferred from GW Pharma (International) B.V., The Netherlands to Jazz Pharmaceuticals Ireland Limited, Ireland.|
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: