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Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

6alpha-ethyl-chenodeoxycholic acid

EU orphan designation number: EU/3/10/753   
Active ingredient: 6alpha-ethyl-chenodeoxycholic acid
Indication: Treatment of primary biliary cirrhosis
Sponsor: Intercept Pharma Ltd
2 Pancras Square, London N1C 4AG, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name OCALIVA on 12/12/2016 with the number EU/1/16/1139

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
30/07/2010 Orphan designation EMA/OD/073/09 (2010)5337 of 27/07/2010
07/05/2014 Corrigendum (2014)3069 of 05/05/2014
21/06/2016 Transfer of orphan designation EMA/OD/073/09/T/01 (2016)3840 of 16/06/2016