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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/3/18/2103   
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 biliary atresia
Sponsor: Albireo AB
Arvid Wallgrens Backe 20, 413 46 Gothenburg, Sverige

  

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
18/12/2018 Orphan designation EMA/OD/165/18 (2018)9018 of 14/12/2018