Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/11/909   
Active ingredient: Macitentan
Indication: Treatment of pulmonary arterial hypertension
Sponsor: Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Opsumit on 27/12/2013 with the number EU/1/13/893

   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
29/09/2011 Orphan designation EMA/OD/023/11 (2011)7042 of 27/09/2011
6/11/2013 Other procedure
2/07/2014 Change of name and/or address of sponsor