Ursodeoxycholic acid


On 22 May 2017, orphan designation (EU/3/17/1878) was granted by the European Commission to IntraBio Ltd, United Kingdom, for ursodeoxycholic acid for the treatment of Niemann-Pick disease.

The sponsorship was transferred to IntraBio Ireland Ltd, Ireland, in April 2019.

Key facts

Active substance
Ursodeoxycholic acid
Intented use
Treatment of Niemann-Pick disease
Date of designation
Orphan designation status
EU designation number

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

IntraBio Ireland Ltd
10 Earlsfort Terrace
Dublin 2
Co. Dublin D02 T380
Tel: +353 1 231 4600

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.

How useful was this page?

Add your rating
1 rating