Luveniq :

Withdrawal of the marketing authorisation application

voclosporin

Overview

On 13 October 2011, Lux Biosciences GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Luveniq, for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Luveniq (PDF/64.82 KB)


    First published: 24/10/2011
    Last updated: 24/10/2011
    EMA/CHMP/835463/2011

  • Key facts

    Name
    Luveniq
    Product number
    EMEA/H/C/002069
    International non-proprietary name (INN) or common name
    • voclosporin
    Active substance
    • Voclosporin
    Date of withdrawal
    13/10/2011
    Company making the application
    Lux Biosciences GmbH
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').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
    1 rating