EU/3/20/2372: Orphan designation for the treatment of glioma
Dabrafenib mesylate
Table of contents
Overview
On 9 December 2020, orphan designation EU/3/20/2372 was granted by the European Commission to Novartis Europharm Limited, Ireland, for dabrafenib mesylate for the treatment of glioma.
Key facts
Active substance |
Dabrafenib mesylate
|
Intended use |
Treatment of glioma
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/20/2372
|
Date of designation |
09/12/2020
|
Sponsor |
Novartis Europharm Limited |
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: