Prometax: Withdrawal of the application to change the marketing authorisation



On 21 November 2013, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a change to the marketing authorisations for the medicinal products Exelon and Prometax. The change concerned an extension of indication to allow the 13.3 mg/24h transdermal patch to be used to treat patients with severe Alzheimer's dementia.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax (rivastigmine) (PDF/82.32 KB)

    First published: 20/12/2013
    Last updated: 20/12/2013

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • rivastigmine
    Active substance
    • rivastigmine
    Date of withdrawal
    Company making the application
    Novartis Europharm Limited
    Withdrawal type

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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