Elmisol: Withdrawal of the marketing authorisation application

levamisole

Overview

On 29 May 2017, ACE Pharmaceuticals BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Elmisol, for the treatment of nephrotic syndrome.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Elmisol (levamisole) (PDF/74.96 KB)


    First published: 23/06/2017
    Last updated: 23/06/2017
    EMA/CHMP/380586/2017

  • Key facts

    Name
    Elmisol
    Product number
    EMEA/H/C/004330
    International non-proprietary name (INN) or common name
    • levamisole
    Active substance
    • levamisole hyhydrochloride
    Date of withdrawal
    29/05/2017
    Company making the application
    ACE Pharmaceuticals BV
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating