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Pharmaceuticals - Community Register

  

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: Lumena Pharma UK Limited
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, 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 Orphan designation EMA/OD/127/13 (2013)9705 of 18/12/2013
14/06/2016 Change of name and/or address of sponsor