Faldaprevir Boehringer Ingelheim:

Withdrawal of the marketing authorisation application

faldaprevir

Overview

On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Faldaprevir Boehringer Ingelheim (faldaprevir) (PDF/89.5 KB)


    First published: 27/06/2014
    Last updated: 27/06/2014
    EMA/354906/2014

  • Key facts

    Name
    Faldaprevir Boehringer Ingelheim
    Product number
    EMEA/H/C/003720
    International non-proprietary name (INN) or common name
    • faldaprevir
    Active substance
    • faldaprevir
    Date of withdrawal
    10/06/2014
    Company making the application
    Boehringer Ingelheim International GmbH
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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