Vekacia: Withdrawal of the marketing authorisation application

ciclosporin

Overview

On 14 November 2008, Novagali Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vekacia, for the treatment of vernal keratoconjunctivitis. Vekacia was designated as an orphan medicinal product on 6 April 2006.

  • List item

    Questions and answers on the withdrawal of the marketing application for Vekacia (PDF/39.72 KB)


    First published: 02/12/2008
    Last updated: 02/12/2008
    EMEA/611497/2008

  • Key facts

    Name
    Vekacia
    Product number
    EMEA/H/C/000904
    International non-proprietary name (INN) or common name
    • ciclosporin
    Active substance
    • ciclosporin
    Date of withdrawal
    14/11/2008
    Company making the application
    Novagali Pharma S.A.
    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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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