Ramelteon: Withdrawal of the marketing authorisation application

Overview

On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.

  • List item

    Questions and answers on the withdrawal of the marketing application for Ramelteon (PDF/47.95 KB)


    First published: 07/10/2008
    Last updated: 07/10/2008
    EMEA/CHMP/502946/2008

  • Key facts

    Name
    Ramelteon
    Product number
    EMEA/H/C/000838
    Date of withdrawal
    19/09/2008
    Company making the application
    Takeda Global Research Development Centre (Europe) Ltd.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating
    Average
    2 ratings