EU/3/14/1339: Orphan designation for the treatment of Dravet syndrome

Cannabidiol

Overview

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.

Key facts

Active substance
Cannabidiol
Intended use
Treatment of Dravet syndrome
Orphan designation status
Positive
EU designation number
EU/3/14/1339
Date of designation
15/10/2014
Sponsor

Jazz Pharmaceuticals Ireland Ltd
Fifth Floor, Waterloo Exchange
Waterloo Road
Dublin 4
Ireland D04 E5W7
Tel: +35316347800
E-mail: corporateaffairsmediainfo@jazzpharma.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Epidyolex at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Update history

DateUpdate
November 2017The sponsorship was transferred to GW Research Ltd, United Kingdom.
April 2019The sponsorship was transferred to GW Pharma (International) B.V., the Netherlands.
June 2023The sponsorship was transferred from GW Pharma (International) B.V., The Netherlands to Jazz Pharmaceuticals Ireland Limited, Ireland.

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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