Spanidin:

Withdrawal of the marketing authorisation application

gusperimus

Overview

On 17 June 2008, Euro Nippon Kayaku GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Spanidin, for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis. Spanidin was designated as an orphan medicine on 29 March 2001.

  • List item

    Questions and answers on the withdrawal of the marketing application for Spanidin (PDF/42.38 KB)


    First published: 03/07/2008
    Last updated: 03/07/2008
    EMEA/309003/2008

  • Key facts

    Name
    Spanidin
    Product number
    EMEA/H/C/000809
    International non-proprietary name (INN) or common name
    • gusperimus
    Active substance
    • gusperimus
    Date of withdrawal
    17/06/2008
    Company making the application
    Euro Nippon Kayaku 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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