EU/3/13/1228

About

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.

Key facts

Active substance
Obeticholic acid
Disease / condition
Treatment of primary sclerosing cholangitis
Date of first decision
16/03/2014
Outcome
Positive
EU designation number
EU/3/13/1228

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

Intercept Pharma International Limited
Ormond Building
31-36 Ormond Quay Street
Dublin 7
Ireland
Tel. +353 1 920 1253
E-mail: reginfo@interceptpharma.com

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.

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