Memantine FGK: Withdrawal of the marketing authorisation application



On 10 January 2013, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Memantine FGK, for the treatment of patients with moderate to severe Alzheimer's disease.

  • List item

    Questions and answers on the withdrawal of the marketing-authorisation application for Memantine FGK (PDF/75.33 KB)

    First published: 18/01/2013
    Last updated: 10/04/2013

  • Key facts

    Memantine FGK
    Product number
    International non-proprietary name (INN) or common name
    • memantine
    Active substance
    • memantine
    Date of withdrawal
    Company making the application
    FGK Representative Service GmbH
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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