Esbriet

RSS

pirfenidone

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

Overview

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.

This EPAR was last updated on 06/12/2022

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
32
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

05/08/2022 Esbriet - EMEA/H/C/002154 - IA/0078

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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

  • dimethyl fumarate
  • Immunosuppressants

Therapeutic indication

Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis.

Assessment history

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