Pharmaceuticals - Union Register


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: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
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
2/10/2018 Transfer of orphan designation EMA/OD/023/11/T/01 (2018)6429 of 27/09/2018