Faldaprevir Boehringer Ingelheim: Withdrawal of the marketing authorisation application


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

  • Key facts

    Faldaprevir Boehringer Ingelheim
    Product number
    Active substance
    • faldaprevir
    Date of withdrawal
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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