EU/3/16/1802: Orphan designation for the treatment of acute myeloid leukaemia
Ivosidenib
Table of contents
Overview
On 12 December 2016, orphan designation (EU/3/16/1802) was granted by the European Commission to QRC Consultants Ltd, United Kingdom, for ivosidenib for the treatment of acute myeloid leukaemia.
The sponsorship was transferred:
- to Quality Regulatory Clinical Ireland Limited, Ireland, in June 2018;
- to FGK Representative Service GmbH, Germany in December 2018;
- to Agios Netherlands B.V., Netherlands, in November 2019 and
- to Les Laboratoires Servier, France, in June 2021.
Key facts
Active substance |
Ivosidenib
|
Intended use |
Treatment of acute myeloid leukaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/16/1802
|
Date of designation |
12/12/2016
|
Sponsor |
Les Laboratoires Servier |
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: