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Community register of orphan medicinal products


GRANTED  

Product information

Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate

EU orphan designation number: EU/3/15/1597   
Active ingredient: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate
Indication: Treatment of acute myeloid leukaemia
Sponsor: Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, 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
16/12/2015 Orphan designation EMA/OD/165/15 (2015)9519 of 14/12/2015