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Register of orphan medicinal products


Product information

(E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

EU orphan designation number: EU/3/05/328   
Active ingredient: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
Indication: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
Sponsor: Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland

   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
7/11/2005 Orphan designation EMEA/OD/056/05 (2005)4352 of 28/10/2005
23/10/2008 Transfer of orphan designation EMEA/OD/056/05/T/01 (2008)6244 of 21/10/2008
30/09/2010 Transfer of orphan designation EMEA/OD/056/05/T/02 (2010)6803 of 28/09/2010
30/05/2011 Change of name and/or address of sponsor EMEA/OD/056/05
1/10/2018 Transfer of orphan designation EMA/OD/056/05/T/03 (2018)6434 of 27/09/2018