EU/3/14/1339

About

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.

The sponsorship was transferred to GW Research Ltd, United Kingdom, in November 2017.

The sponsorship was transferred to GW Pharma (International) B.V., the Netherlands, in April 2019.

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
Disease / condition
Treatment of Dravet syndrome
Date of first decision
15/10/2014
Outcome
Positive
EU designation number
EU/3/14/1339

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 iconorphan medicine assessment report .

Sponsor's contact details

GW Pharma (International) B.V. 
Databankweg 26
Amersfoort
Utrecht
3821 AL
Netherlands
Tel: +31 (0) 33 798 1015
E-mail: gwreg@gwpharm.com

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;

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