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Pharmaceuticals - Union Register

  

Register of orphan medicinal products


GRANTED  

Product information

Ursodeoxycholic acid

EU orphan designation number: EU/3/17/1878   
Active ingredient: Ursodeoxycholic acid
Indication: Treatment of Niemann-Pick disease
Sponsor: IntraBio Ireland Ltd
10 Earlsfort Terrace, Dublin 2, Co. Dublin, D02 T380, Ireland

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/05/2017 Orphan designation EMA/OD/316/16 (2017)3611 of 22/05/2017
12/04/2019 Transfer of orphan designation EMA/OD/0000005394 (2019)2937 of 10/04/2019