Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Esbriet   
Auth. number : EU/1/11/667
Active substance : Pirfenidone
Orphan market exclusivity for "Treatment of idiopathic pulmonary fibrosis" (based on designation EU/3/04/241) started on 02/03/2011
   10 years of market exclusivity
   This orphan market exclusivity will expire on 02/03/2021
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: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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 - Notification 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 PSUSA - Maintain EMEA/H/C/2154/PSUV/17 (2013)9660 of 17/12/2013
01/07/2014 Centralised - 2-Monthly update EMEA/H/C/2154/II/16 (2014)4495 of 27/06/2014
23/10/2014 Centralised - Variation EMEA/H/C/2154/II/21
Updated with Decision(2015)955 of 12/02/2015
03/12/2014 Centralised - Notification EMEA/H/C/2154/N/25
Updated with Decision(2015)955 of 12/02/2015
18/12/2014 Centralised - Variation EMEA/H/C/2154/IB/24/G
Updated with Decision(2015)955 of 12/02/2015
16/02/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2154/T/27 (2015)955 of 12/02/2015
07/05/2015 Centralised - Variation EMEA/H/C/2154/IAin/28
Updated with Decision(2015)6264 of 08/09/2015
10/09/2015 Centralised - Renewal EMEA/H/C/2154/R/29 (2015)6264 of 08/09/2015
04/05/2016 Centralised - Notification EMEA/H/C/2154/N/36
Updated with Decision(2017)2852 of 24/04/2017
01/08/2016 Centralised - Variation EMEA/H/C/2154/IA/38/G
Updated with Decision(2017)2852 of 24/04/2017
26/04/2017 Centralised - Variation EMEA/H/C/002154/X/0035/G (2017)2852 of 24/04/2017
26/06/2017 Centralised - Variation EMEA/H/C/002154/IB/46/G