Clopidogrel Teva Pharma: Withdrawal of the marketing authorisation application



On 22 April 2009, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel) (PDF/41.24 KB)

    First published: 24/06/2009
    Last updated: 24/06/2009

  • Key facts

    Clopidogrel Teva Pharma
    Product number
    International non-proprietary name (INN) or common name
    • clopidogrel
    Active substance
    • clopidogrel
    Date of withdrawal
    Company making the application
    Teva Pharma B.V.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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