EU/3/15/1520: Orphan designation for the treatment of perinatal asphyxia

Cannabidiol

Overview

On 28 July 2015, orphan designation (EU/3/15/1520) was granted by the European Commission to GW Pharma Ltd, United Kingdom, for cannabidiol for the treatment of perinatal asphyxia.

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

Key facts

Active substance
Cannabidiol
Intended use
Treatment of perinatal asphyxia
Orphan designation status
Positive
EU designation number
EU/3/15/1520
Date of designation
28/07/2015
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