Esbriet

RSS

pirfenidone

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 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)
  • Idiopathic Pulmonary Fibrosis
  • Lung Diseases
  • Respiratory Tract Diseases
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
79639 Grenzach-Wyhlen
Germany

Product information

24/03/2023 Esbriet - EMEA/H/C/002154 - II/0074

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Product information documents contain:

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.

Assessment history

Changes since initial authorisation of medicine

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