EU/3/16/1621

About

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
Disease / condition
Treatment of glioma
Date of first decision
17/02/2016
Outcome
Positive
EU designation number
EU/3/16/1621

Review of designation

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

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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