Vibativ: Withdrawal of the marketing authorisation application
On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Astellas withdraws its marketing authorisation application for Vibativ (telavancin) (PDF/23.99 KB)
First published: 24/10/2008
Last updated: 24/10/2008
Withdrawal letter : Vibativ (PDF/67.58 KB)
First published: 20/10/2008
Last updated: 20/10/2008
Questions and answers on the withdrawal of the marketing application for Vibativ (PDF/42.73 KB)
First published: 28/11/2008
Last updated: 28/11/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').