Factive: Withdrawal of the marketing authorisation application
On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, community-acquired pneumonia and acute exacerbation of chronic bronchitis.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Factive (PDF/360.58 KB)Adopted
First published: 20/11/2009
Last updated: 20/11/2009
Menarini International Operations Luxembourg withdraws its marketing authorisation application for Factive (PDF/23.42 KB)
First published: 23/06/2009
Last updated: 23/06/2009
Withdrawal letter : Factive (PDF/253.81 KB)
First published: 17/06/2009
Last updated: 17/06/2009
Questions and answers on the withdrawal of the marketing authorisation application for Factive (gemifloxacin) (PDF/38.19 KB)
First published: 01/07/2009
Last updated: 01/07/2009
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').