Navigation path

Pharmaceuticals - Community Register


Community 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: ARIAD Pharma 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 Centralised Orphan - Designation EMEA/OD/121/09 (2010)789 of 02/02/2010
29/08/2014 Centralised Orphan - Change of address
17/09/2014 Centralised Orphan - Change of address