This is a summary of the European public assessment report (EPAR) for Esbriet. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Esbriet.
Esbriet : EPAR - Summary for the public (PDF/78.52 KB)
First published: 11/03/2011
Last updated: 05/05/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Idiopathic Pulmonary Fibrosis
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
16/11/2020 Esbriet - EMEA/H/C/002154 - II/0066/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis.