Opsiria: Withdrawal of the marketing authorisation application

sirolimus

Overview

On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Opsiria (sirolimus) (PDF/92.98 KB)


    First published: 27/05/2016
    Last updated: 27/05/2016
    EMA/358774/2016

  • Key facts

    Name
    Opsiria
    Product number
    EMEA/H/C/003978
    International non-proprietary name (INN) or common name
    • sirolimus
    Active substance
    • Sirolimus
    Date of withdrawal
    20/05/2016
    Company making the application
    Santen Oy
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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