EU/3/16/1621: Orphan designation for the treatment of glioma

Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant

Overview

On 17 February 2016, orphan designation (EU/3/16/1621) was granted by the European Commission to GW Research Ltd, United Kingdom, for delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant for the treatment of glioma.

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

Key facts

Active substance
Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant
Intented use
Treatment of glioma
Orphan designation status
Positive
EU designation number
EU/3/16/1621
Date of designation
17/02/2016
Sponsor

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

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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:

How useful was this page?

Add your rating