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Community register of orphan medicinal products


GRANTED  

Product information

(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid

EU orphan designation number: EU/3/12/1041   
Active ingredient: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid
Indication: Treatment of primary biliary cirrhosis
Sponsor: Albireo AB
Arvid Wallgrens Backe 20, 413 46 Gothenburg, Sverige

   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
13/08/2012 Orphan designation EMA/OD/024/12 (2012)5804 of 09/08/2012