EU/3/16/1621: Orphan designation for the treatment of glioma
Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant
Table of contents
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
|
Intended 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. |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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: