Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information


EU orphan designation number: EU/3/09/707   
Active ingredient: Macitentan
Indication: Treatment of idiopathic pulmonary fibrosis
Sponsor: Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België

   Public summary of scientific opinion    

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/02/2010 Orphan designation EMEA/OD/104/09 (2010)653 of 28/01/2010
2/07/2014 Change of name and/or address of sponsor
1/10/2018 Transfer of orphan designation EMA/OD/104/09/T/01 (2018)6428 of 27/09/2018