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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/3/13/1217   
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 primary sclerosing cholangitis
Sponsor: Shire Pharmaceutical Ireland limited
5 Riverwalk, Citywest Business Campus, Dublin 24 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
20/12/2013 Orphan designation EMA/OD/127/13 (2013)9705 of 18/12/2013
14/06/2016 Change of name and/or address of sponsor
07/09/2016 Transfer of orphan designation EMA/OD/127/13/T/01 (2016)5743 of 05/09/2016