Esbriet
pirfenidone
Table of contents
Overview
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.
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List item
Esbriet : EPAR - Summary for the public (PDF/121.88 KB)
First published: 11/03/2011
Last updated: 14/04/2023
EMA/CHMP/174479/2011 -
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List item
Esbriet : EPAR - Risk Management Plan (PDF/906.93 KB) (new)
First published: 17/05/2023
Authorisation details
Product details | |
---|---|
Name |
Esbriet
|
Agency product number |
EMEA/H/C/002154
|
Active substance |
Pirfenidone
|
International non-proprietary name (INN) or common name |
pirfenidone
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04AX05
|
Publication details | |
---|---|
Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
33
|
Date of issue of marketing authorisation valid throughout the European Union |
27/02/2011
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
24/03/2023 Esbriet - EMEA/H/C/002154 - II/0074
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.