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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/3/10/810   
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-essential thrombocythaemia myelofibrosis
Sponsor: Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland

   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
2/12/2010 Orphan designation EMA/OD/084/10 (2010)8595 of 26/11/2010
8/02/2011 Transfer of orphan designation EMA/OD/084/10/T/01 (2011)782 of 4/02/2011
6/11/2012 Change of name and/or address of sponsor EMA/OD/084/10
3/05/2017 Transfer of orphan designation EMA/OD/084/10/T/02 (2017)2966 of 28/04/2017
12/06/2018 Transfer of orphan designation EMA/OD/084/10/T/03 (2018)3808 of 8/06/2018