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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/3/13/1215   
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 biliary cirrhosis
Sponsor: Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, 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/121/13 (2013)9703 of 18/12/2013
14/06/2016 Change of name and/or address of sponsor
07/09/2016 Transfer of orphan designation EMA/OD/121/13/T/01 (2016)5742 of 05/09/2016
06/11/2017 Change of name and/or address of sponsor