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.
Esbriet : EPAR - Summary for the public (PDF/78.52 KB)
First published: 11/03/2011
Last updated: 05/05/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Idiopathic Pulmonary Fibrosis
|Anatomical therapeutic chemical (ATC) code||
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.
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
17/04/2018 Esbriet - EMEA/H/C/002154 - IAIN/0053/G
- 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
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Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis.