Retisert:

Withdrawal of the marketing authorisation application

fluocinolone acetonide

Overview

On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005.

  • List item

    Questions and answers on the withdrawal of the marketing application for Retisert (PDF/35.19 KB)


    First published: 03/09/2007
    Last updated: 03/09/2007
    EMEA/342023/2007

  • Key facts

    Name
    Retisert
    Product number
    EMEA/H/C/000787
    International non-proprietary name (INN) or common name
    • fluocinolone acetonide
    Active substance
    • Fluocinolone acetonide
    Date of withdrawal
    16/07/2007
    Company making the application
    Bausch Lomb Ireland
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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