Esbriet: Withdrawal of the application to change the marketing authorisation

pirfenidone

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.

  • 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

  • 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
    • pirfenidone
    Active substance
    • Pirfenidone
    Date of withdrawal
    19/05/2021
    Company making the application
    Roche Registration GmbH
    Withdrawal type
    Post-authorisation

    All documents

    Related content

    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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