EU/3/20/2261: Orphan designation for the treatment of chronic myeloid leukaemia
Asciminib
Table of contents
Overview
On 24 March 2020, orphan designation EU/3/20/2261 was granted by the European Commission to Novartis Europharm Limited, Ireland, for asciminib for the treatment of chronic myeloid leukaemia.
The medicinal product has been authorised in the EU as Scemblix since 25 August 2022.
Key facts
Active substance |
Asciminib
|
Intended use |
Treatment of chronic myeloid leukaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/20/2261
|
Date of designation |
24/03/2020
|
Sponsor |
Novartis Europharm Limited |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Scemblix at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the
orphan medicine assessment report
.
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: