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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/3/10/794   
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 primary 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
11/10/2010 Orphan designation EMA/OD/069/10 (2010)6939 of 01/10/2010
08/02/2011 Transfer of orphan designation EMA/OD/069/10/T/01 (2011)781 of 04/02/2011
06/11/2012 Change of name and/or address of sponsor EMA/OD/069/10