Cokiera: Withdrawal of the marketing authorisation application

dasabuvir / ombitasvir / paritaprevir / ritonavir

Overview

On 3 August 2016, AbbVie Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cokiera, for the treatment of chronic hepatitis C.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Cokiera (dasabuvir / ombitasvir / paritaprevir / ritonavir) (PDF/74.2 KB)


    First published: 16/09/2016
    Last updated: 16/09/2016
    EMA/541043/2016

  • Key facts

    Name
    Cokiera
    Product number
    EMEA/H/C/004235
    International non-proprietary name (INN) or common name
    • dasabuvir / ombitasvir / paritaprevir / ritonavir
    Active substance
    • dasabuvir sodium, ombitasvir, paritaprevir, ritonavir
    Date of withdrawal
    03/08/2016
    Company making the application
    AbbVie Ltd.
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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