EU/3/20/2329: Orphan designation for the treatment of cholangiocarcinoma
Table of contents
On 21 August 2020, orphan designation EU/3/20/2329 was granted by the European Commission to YES Pharmaceutical Development Services GmbH, Germany, for infigratinib for the treatment of cholangiocarcinoma.
Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2022 on request of the Sponsor.
Treatment of cholangiocarcinoma
|Orphan designation status||
|EU designation number||
|Date of designation||
Helsinn Birex Pharmaceuticals Limited
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
|November 2022||Product withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.|
|September 2021||The sponsorship was transferred to Helsinn Birex Pharmaceuticals Limited, Ireland.|
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: