Vibativ: Withdrawal of the marketing authorisation application

telavancin

Overview

On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.

  • List item

    Questions and answers on the withdrawal of the marketing application for Vibativ (PDF/42.73 KB)


    First published: 28/11/2008
    Last updated: 28/11/2008
    EMEA/586612/2008

  • Key facts

    Name
    Vibativ
    Product number
    EMEA/H/C/000864
    International non-proprietary name (INN) or common name
    • telavancin
    Active substance
    • telavancin
    Date of withdrawal
    20/10/2008
    Company making the application
    Astellas Pharma Europe B. V.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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