EU/3/20/2329: Orphan designation for the treatment of cholangiocarcinoma



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.

The sponsorship was transferred to Helsinn Birex Pharmaceuticals Limited, Ireland, in September 2021.

Key facts

Active substance
Intended use
Treatment of cholangiocarcinoma
Orphan designation status
EU designation number
Date of designation

Helsinn Birex Pharmaceuticals Limited
Damastown Road 
Dublin 15 
D15 X925 
Co. Dublin 
Tel. +353 1 822 5404

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

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:

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