EU/3/18/2066: Orphan designation for the treatment of biliary tract cancer
Table of contents
On 24 August 2018, orphan designation (EU/3/18/2066) was granted by the European Commission to Incyte Biosciences Distribution B.V., the Netherlands, for pemigatinib for the treatment of biliary tract cancer.
Pemigatinib has been authorised in the EU as Pemazyre since 26 March 2021.
Treatment of biliary tract cancer
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Incyte Biosciences Distribution B.V.
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Pemazyre 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 .
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: