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Community register of orphan medicinal products


Product information

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

EU orphan designation number: EU/3/11/886   
Active ingredient: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt
Indication: Treatment of post-polycythaemia vera myelofibrosis
Sponsor: Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, 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
09/08/2011 Orphan designation EMA/OD/019/11 (2011)5811 of 05/08/2011
29/02/2012 Transfer of orphan designation EMA/OD/019/11/T/01 (2012)1383 of 27/02/2012
21/05/2013 Transfer of orphan designation EMA/OD/019/11/T/02 (2013)2932 of 15/05/2013
12/06/2018 Transfer of orphan designation EMA/OD/019/11/T/03 (2018)3799 of 08/06/2018