Zenhale: Withdrawal of the marketing authorisation application

Overview

On 5 November 2010, Schering-Plough Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zenhale, for the maintenance treatment of asthma.

  • List item

    Questions and answers on withdrawal of the marketing authorisation application for Zenhale (PDF/55.52 KB)


    First published: 25/11/2010
    Last updated: 25/11/2010

  • Key facts

    Name
    Zenhale
    Product number
    EMEA/H/C/001217
    Active substance
    • formoterol fumarate
    • Mometasone furoate
    Date of withdrawal
    05/11/2010
    Company making the application
    Schering-Plough Europe
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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