On 21 March 2014, orphan designation (EU/3/13/1228) was granted by the European Commission to Intercept Italia S.R.L., Italy, for obeticholic acid for the treatment of primary sclerosing cholangitis.
The sponsorship was transferred to Intercept Pharma Ltd, United Kingdom, in June 2016 and to Intercept Pharma International Limited, Ireland, in December 2020.
|Disease / condition||
Treatment of primary sclerosing cholangitis
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
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.