Pharmaceuticals - Community Register


Community register of orphan medicinal products


Product information


EU orphan designation number: EU/3/04/241   
Active ingredient: Pirfenidone
Indication: Treatment of idiopathic pulmonary fibrosis
Sponsor: Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Esbriet on 28/02/2011 with the number EU/1/11/667

   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
18/11/2004 Orphan designation EMEA/OD/052/04 (2004)4458 of 16/11/2004
22/05/2009 Transfer of orphan designation EMEA/OD/052/04/T/01 (2009)4099 of 19/05/2009
30/05/2011 Change of name and/or address of sponsor EMEA/OD/052/04
02/02/2012 Change of name and/or address of sponsor EMEA/OD/052/04
28/08/2013 Change of name and/or address of sponsor
02/03/2015 Transfer of orphan designation EMA/OD/052/04/T/02 (2015)1438 of 26/02/2015
28/03/2018 Transfer of orphan designation EMEA/OD/052/04/T/03 (2018)2006 of 26/03/2018