Esbriet: Withdrawal of the application to change the marketing authorisation
pirfenidone
Table of contents
Overview
Roche Registration GmbH withdrew its application for the use of Esbriet in the treatment of patients with unclassifiable interstitial lung disease.
The company withdrew the application on 19 May 2021.
Key facts
Name |
Esbriet |
Product number |
EMEA/H/C/002154 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
27/02/2011 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
19/05/2021 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
-
List item
Withdrawal assessment report for Esbriet (II-69) (PDF/4.91 MB)
Adopted
First published: 25/06/2021
EMA/286537/2021 -
List item
Withdrawal letter: Esbriet (II-69) (PDF/11.73 KB)
First published: 25/06/2021 -
List item
Questions and answers on the withdrawal of application to change the marketing authorisation for Esbriet (pirfenidone) (II-69) (PDF/123 KB)
First published: 25/06/2021
EMA/354062/2021 -
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').