EU/3/18/1994: Orphan designation for the treatment of biliary tract cancer
Table of contents
On 21 March 2018, orphan designation (EU/3/18/1994) was granted by the European Commission to QRC Consultants Ltd, United Kingdom, for ivosidenib for the treatment of biliary tract cancer.
The sponsorship was transferred:
- to Quality Regulatory Clinical Ireland Limited, Ireland, in August 2018;
- to Agios Netherlands B.V., Netherlands in December 2020 and
- to Les Laboratoires Servier, France, in June 2021.
Treatment of biliary tract cancer
|Orphan designation status||
|EU designation number||
|Date of designation||
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.
Documents related to this orphan designation evaluation
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: