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Community register of orphan medicinal products


GRANTED  

Product information

(4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride

EU orphan designation number: EU/3/13/1214   
Active ingredient: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride
Indication: Treatment of Alagille syndrome
Sponsor: Lumena Pharma UK Limited
C/O Arnold & Porter (UK) LLP Tower 42, 25 Old Broad Street, London, EC2N 1HQ, United Kingdom

   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
20/12/2013 Centralised Orphan - Designation EMA/OD/120/13 (2013)9702 of 18/12/2013