Withdrawal of the marketing authorisation application
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.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Spanidin (PDF/221.56 KB)Adopted
First published: 05/09/2008
Last updated: 05/09/2008
Euro Nippon Kayaku GmbH withdraws its marketing authorisation application for Spanidin (gusperimus) (PDF/18.76 KB)
First published: 19/06/2008
Last updated: 19/06/2008
Withdrawal letter : Spanidin (PDF/78.35 KB)
First published: 17/06/2008
Last updated: 17/06/2008
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
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').