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Community register of orphan medicinal products


GRANTED  

Product information

N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt

EU orphan designation number: EU/3/09/622   
Active ingredient: N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt
Indication: Treatment of acute myeloid leukaemia
Sponsor: Daiichi Sankyo Europe GmbH
Zielstattstrasse 48, 81379 München, Deutschland

   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
25/03/2009 Orphan designation EMEA/OD/105/08 (2009)2203 of 23/03/2009
02/07/2015 Transfer of orphan designation EMA/OD/105/08/T/01 (2015)4527 of 26/06/2015
10/08/2016 Transfer of orphan designation EMA/OD/105/08/T/02 (2016)5272 of 08/08/2016