Pharmaceuticals - Community Register

  

Community register of orphan medicinal products


GRANTED  

Product information

Dexrazoxane

EU orphan designation number: EU/3/01/059   
Active ingredient: Dexrazoxane
Indication: Treatment of anthracycline extravasations
Sponsor: Norgine B.V.
Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland
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 Centralised Orphan - Designation EMEA/OD/021/01 (2001)2716 of 19/09/2001
27/08/2010 Centralised Orphan - Transfer of orphan designation EMEA/OD/021/01/T/01 (2010)5971 of 25/08/2010
26/09/2013 Centralised Orphan - Transfer of orphan designation EMEA/OD/021/01/T/02 (2013)6302 of 24/09/2013