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Community register of orphan medicinal products


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Product information

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate

EU orphan designation number: EU/3/10/811   
Active ingredient: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate
Indication: Treatment of post-polycythaemia vera myelofibrosis
Sponsor: Sanofi-Aventis groupe
54 rue La Boétie, 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
02/12/2010 Orphan designation EMA/OD/092/10 (2010)8596 of 26/11/2010
08/02/2011 Transfer of orphan designation EMA/OD/092/10/T/01 (2011)783 of 04/02/2011
06/11/2012 Change of name and/or address of sponsor EMA/OD/092/10