Pharmaceuticals - Community Register


Community list of not active orphan medicinal products


Product information


EU orphan designation number: EU/3/01/019
Active ingredient: bosentan
Indication: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
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
16/02/2001 Orphan designation EMEA/OD/036/00 (2001)367 of 14/02/2001
23/07/2001 Transfer of orphan designation EMEA/OD/036/00/T/01 (2001)1699 of 20/07/2001
17/05/2012 Removal of orphan designation from Community Register