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 07/05/2018

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
Anatomical therapeutic chemical (ATC) code
L04AX05
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
28/02/2011
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

17/04/2018 Esbriet - EMEA/H/C/002154 - IAIN/0053/G

Contents

  • 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.

Pharmacotherapeutic group

Immunosuppressive agents

Therapeutic indication

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

Assessment history

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