Sliwens: Withdrawal of the marketing authorisation application
On 18 December 2009, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sliwens, for use in adults with chronic (long-term) insomnia who have difficulty staying asleep.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Sliwens (PDF/1019.78 KB)Adopted
First published: 01/06/2010
Last updated: 01/06/2010
Sanofi Aventis withdraws its marketing authorisation application for Sliwens (PDF/45.62 KB)
First published: 21/12/2009
Last updated: 21/12/2009
Withdrawal letter : Sliwens (PDF/45.56 KB)
First published: 18/12/2009
Last updated: 18/12/2009
Questions and answers on withdrawal of marketing authorisation application for Sliwens (eplivanserin) (PDF/50.43 KB)
First published: 20/01/2010
Last updated: 20/01/2010
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').