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Register of orphan medicinal products


GRANTED  

Product information

N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt

EU orphan designation number: EU/3/11/887   
Active ingredient: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt
Indication: Treatment of post-essential thrombocythaemia myelofibrosis
Sponsor: DLRC Pharma Services Ltd
Chesterfield House, Clonmannon, Ashford, Co. Wicklow, A67 WR29, Ireland

   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
9/08/2011 Orphan designation EMA/OD/020/11 (2011)5812 of 5/08/2011
29/02/2012 Transfer of orphan designation EMA/OD/020/11/T/01 (2012)1371 of 27/02/2012
21/05/2013 Transfer of orphan designation EMA/OD/020/11/T/02 (2013)2933 of 15/05/2013
12/06/2018 Transfer of orphan designation EMA/OD/020/11/T/03 (2018)3801 of 8/06/2018
26/02/2019 Transfer of orphan designation EMA/OD/0000003764 (2019)1622 of 21/02/2019