Withdrawal of the marketing authorisation application
On 28 July 2009, Glaxo Group Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Bosatria, for the treatment of adults with hypereosinophilic syndrome to reduce or eliminate the need for corticosteroid therapy and to reduce blood eosinophil counts.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
GlaxoSmithKline withdraws its marketing authorisation application for Bosatria (PDF/30.95 KB)
First published: 29/07/2009
Last updated: 29/07/2009
Withdrawal letter : Bosatria (PDF/775.06 KB)
First published: 28/07/2009
Last updated: 28/07/2009
Withdrawal assessment report for Bosatria (PDF/1.81 MB)Adopted
First published: 23/07/2009
Last updated: 23/07/2009
Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab) (PDF/33.78 KB)
First published: 20/08/2009
Last updated: 20/08/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').