Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Esbriet   
Auth. number : EU/1/11/667
INN : Pirfenidone
Orphan status based on designation EU/3/04/241 added on 02/03/2011
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AX - Other immunosuppressive agents
Chemical substance: L04AX05 - Pirfenidone
(See WHO ATC Index)
Indication: Esbriet is indicated in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF).
Marketing Authorisation Holder: InterMune UK Limited
Grove House, 2nd Floor, 248A Marylebone Road, London NW1 6JZ, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2154 (2011)1468 of 28/02/2011
02/03/2011 Centralised - Authorisation EMEA/H/C/2154 (2011)1469 of 28/02/2011
20/04/2011 Centralised - Variation EMEA/H/C/2154/IA/1
Updated with Decision(2011)5386 of 20/07/2011
26/07/2011 Centralised - Variation (2011)5386 of 20/07/2011
05/08/2011 Centralised - Variation EMEA/H/C/2154/IA/3
Updated with Decision(2012)1497 of 02/03/2012
05/12/2011 Centralised - Variation EMEA/H/C/2154/N/5
Updated with Decision(2012)1497 of 02/03/2012
19/01/2012 Centralised - Variation EMEA/H/C/2154/IA/6/G
Updated with Decision(2012)1497 of 02/03/2012
06/03/2012 Centralised - Variation (2012)1497 of 02/03/2012
18/06/2012 Centralised - Variation EMEA/H/C/2154/IA/7/G
Updated with Decision(2012)7917 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7917 of 29/10/2012
25/04/2013 Centralised - Variation EMEA/H/C/2154/II/8
Updated with Decision(2013)9660 of 17/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/2154/IB/11/G
Updated with Decision(2013)9660 of 17/12/2013
21/08/2013 Centralised - Variation EMEA/H/C/2154/IAin/12/G
Updated with Decision(2013)9660 of 17/12/2013
19/12/2013 Centralised - Maintain EMEA/H/C/2154/PSUV/17 (2013)9660 of 17/12/2013
01/07/2014 Centralised - Variation EMEA/H/C/2154/II/16 (2014)4495 of 27/06/2014