Ramelteon: Withdrawal of the marketing authorisation application


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

  • Key facts

    Product number
    Date of withdrawal
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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