EU/3/14/1288: Orphan designation for the treatment of primary sclerosing cholangitis

Norursodeoxycholic acid


On 4 July 2014, orphan designation (EU/3/14/1288) was granted by the European Commission to Dr Falk Pharma GmbH, Germany, for norursodeoxycholic acid for the treatment of primary sclerosing cholangitis.

Key facts

Active substance
Norursodeoxycholic acid
Intended use
Treatment of primary sclerosing cholangitis
Orphan designation status
EU designation number
Date of designation
Dr Falk Pharma GmbH
Leinenweberstrasse 5
D-79108 Freiburg i.Br.
Tel. +49 7611 5140
Fax +49 7611 514391

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:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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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