Table of contents
Esbriet is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF). IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath. ‘Idiopathic’ means that the cause of the disease is unknown.
Esbriet contains the active substance pirfenidone.
Esbriet : EPAR - Summary for the public (PDF/121.88 KB)
First published: 11/03/2011
Last updated: 14/04/2023
Esbriet : EPAR - Risk Management Plan (PDF/906.93 KB) (new)
First published: 17/05/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
24/03/2023 Esbriet - EMEA/H/C/002154 - II/0074
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.