Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/03/139
Active ingredient: bosentan
Indication: Treatment of systemic sclerosis
Sponsor: Actelion Registration Ltd
90 Fetter Lane, London EC4A 7JP, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Tracleer on 15/05/2002 with the number EU/1/02/220

   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
19/03/2003 Orphan designation EMEA/OD/069/02 (2003)860 of 17/03/2003
04/04/2014 Removal of orphan designation from Community Register