Sinerem: Withdrawal of the marketing authorisation application

superparamagnetic iron oxide nanoparticles stabilised with dextran and sodium citrate

Overview

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
    EMEA/599866/2007

  • Key facts

    Name
    Sinerem
    Product number
    EMEA/H/C/000801
    International non-proprietary name (INN) or common name
    • superparamagnetic iron oxide nanoparticles stabilised with dextran and sodium citrate
    Active substance
    • superparamagnetic iron oxide nanoparticles stabilised with dextran and sodium citrate
    Date of withdrawal
    13/12/2007
    Company making the application
    Guerbet
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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