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: InterMune UK Limited
Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom
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 Centralised Orphan - Designation EMEA/OD/052/04 (2004)4458 of 16/11/2004
22/05/2009 Centralised Orphan - Transfer of orphan designation EMEA/OD/052/04/T/01 (2009)4099 of 19/05/2009
30/05/2011 Orphan - Change name of sponsor EMEA/OD/052/04
02/02/2012 Centralised Orphan - Change of address EMEA/OD/052/04
28/08/2013 Centralised Orphan - Change of address