Lenalidomide Celgene Europe: Withdrawal of the marketing authorisation application
On 30 May 2008, Celgene Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lenalidomide Celgene Europe, for the treatment of anaemia due to myelodysplastic syndromes. Lenalidomide Celgene Europe was designated as an orphan medicinal product on 8 March 2004.
Lenalidomide Celgene Europe
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Lenalidomide Celgene Europe (PDF/412.8 KB)Adopted
First published: 01/08/2008
Last updated: 01/08/2008
Celgene Europe Limited withdraws its marketing authorisation application for Lenalidomide Celgene Europe (lenalidomide) (PDF/24.92 KB)
First published: 04/06/2008
Last updated: 04/06/2008
Withdrawal letter : Lenalidomide Celgene Europe (PDF/36.02 KB)
First published: 30/05/2008
Last updated: 30/05/2008
Questions and answers on the withdrawal of the marketing application for Lenalidomide Celgene Europe (PDF/43.52 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 (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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').