EU/3/14/1329

About

On 22 August 2014, orphan designation (EU/3/14/1329) was granted by the European Commission to Diamond BioPharm Ltd, United Kingdom, for variant of recombinant human fibroblast growth factor 19 for the treatment of primary biliary cirrhosis.

The sponsorship was transferred to Diamond ROC EOOD, Bulgaria, in March 2019. 

The sponsorship was transferred to Diamond Pharma Services Ireland Limited in February 2020.

Key facts

Active substance
Variant of recombinant human fibroblast growth factor 19
Disease / condition
Treatment of primary biliary cirrhosis
Date of first decision
22/08/2014
Outcome
Positive
EU designation number
EU/3/14/1329

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

Diamond Pharma Services Ireland Limited 
Coliemore House
Coliemore Road
Dalkey
Co. Dublin
Ireland 
Tel. 02039119410
E-mail: mgraham@diamondpharmaservices.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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