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Register of orphan medicinal products


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/3/09/716   
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 chronic myeloid leukaemia
Sponsor: Incyte Biosciences Distribution B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Iclusig on 1/07/2013 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
4/02/2010 Orphan designation EMEA/OD/121/09 (2010)789 of 2/02/2010
17/04/2013 Other procedure
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/121/09/T/01 (2016)7586 of 18/11/2016
21/05/2018 Transfer of orphan designation EMA/OD/121/09/T/02 (2018)3140 of 16/05/2018