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Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/10/770
Active ingredient: 1-[2-(Benzo[1,2,5]thiadiazol-5-ylamino)-6-(2,6-dichloro-phenyl)-pyrido[2,3-d]pyrimidin-7-yl]-3-tert-butyl-urea
Indication: Treatment of acute myeloid leukaemia
Sponsor: Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France

   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
22/09/2010 Orphan designation EMA/OD/023/10 (2010)6637 of 20/09/2010
06/11/2012 Change of name and/or address of sponsor EMA/OD/023/10
24/10/2014 Removal of orphan designation from Community Register