Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information

Arsenic trioxide

EU orphan designation number: EU/3/00/008
Active ingredient: Arsenic trioxide
Indication: Treatment of acute promyelocytic leukaemia
Sponsor: Cephalon Europe
5 rue Charles Martigny, 94700 Maisons-Alfort CEDEX, France
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Trisenox on 05/03/2002 with the number EU/1/02/204

   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
13/11/2000 Orphan designation EMEA/OD/008/00 (2000)3024 of 18/10/2000
18/10/2001 Transfer of orphan designation EMEA/OD/008/00/T/01 (2001)3104 of 17/10/2001
13/04/2006 Transfer of orphan designation EMEA/OD/008/00/T/02 (2006)1636 of 11/04/2006
05/06/2007 Transfer of orphan designation EMEA/OD/008/00/T/03 (2007)2426 of 01/06/2007
07/03/2012 Removal of orphan designation from Community Register