Sinerem: Withdrawal of the marketing authorisation application


On 13 December 2007, Guerbet officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sinerem, intended for diagnostic use for the characterisation of lymph nodes visualised by MRI (magnetic resonance imaging) in the evaluation of primary tumour spread in pelvic cancers.

  • List item

    Questions and answers on the withdrawal of the marketing application for Sinerem (PDF/39.17 KB)

    First published: 24/01/2008
    Last updated: 24/01/2008

  • Key facts

    Product number
    Date of withdrawal
    Company making the application
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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