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Register of orphan medicinal products


GRANTED  

Product information

(5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-beta-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one

EU orphan designation number: EU/3/14/1270   
Active ingredient: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-beta-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one
Indication: Treatment of biliary tract cancer
Sponsor: Mundipharma Corporation (Ireland) Limited
Millbank House, 18 Arkle Road, Sandyford Industrial Estate, Dublin 18, Co. Dublin, D18 C6R3, 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
6/06/2014 Orphan designation EMA/OD/199/13 (2014)3857 of 4/06/2014
16/10/2017 Transfer of orphan designation EMA/OD/199/13/T/01 (2017)7022 of 13/10/2017
15/04/2019 Transfer of orphan designation EMA/OD/0000005740 (2019)2968 of 11/04/2019