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Community register of orphan medicinal products


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Product information

Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]

EU orphan designation number: EU/3/09/715   
Active ingredient: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]
Indication: Treatment of acute lymphoblastic leukaemia
Sponsor: Incyte Biosciences UK Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Iclusig on 01/07/2013 with the number EU/1/13/839

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
04/02/2010 Orphan designation EMEA/OD/122/09 (2010)788 of 02/02/2010
29/08/2014 Change of name and/or address of sponsor
17/09/2014 Change of name and/or address of sponsor
22/11/2016 Transfer of orphan designation EMA/OD/122/09/T/01 (2016)7590 of 18/11/2016
20/01/2017 Corrigendum (2016)7590 cor of 18/11/2016