Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/01/059   
Active ingredient: Dexrazoxane
Indication: Treatment of anthracycline extravasations
Sponsor: Clinigen Healthcare Limited
Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Savene on 28/07/2006 with the number EU/1/06/350

   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
21/09/2001 Orphan designation EMEA/OD/021/01 (2001)2716 of 19/09/2001
27/08/2010 Transfer of orphan designation EMEA/OD/021/01/T/01 (2010)5971 of 25/08/2010
26/09/2013 Transfer of orphan designation EMEA/OD/021/01/T/02 (2013)6302 of 24/09/2013
31/07/2014 Transfer of orphan designation EMA/OD/021/01/T/03 (2014)5532 of 29/07/2014