Aquilda: Withdrawal of the marketing authorisation application
Table of contents
On 23 May 2008, 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 Aquilda, for the treatment of euvolaemic and hypervolaemic dilutional hyponatraemia.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Aquilda (PDF/550.76 KB)Adopted
First published: 25/07/2008
Last updated: 25/07/2008
Sanofi-aventis withdraws its marketing authorisation application for Aquilda (satavaptan) (PDF/18.58 KB)
First published: 28/05/2008
Last updated: 28/05/2008
Withdrawal letter : Aquilda (PDF/47.51 KB)
First published: 23/05/2008
Last updated: 23/05/2008
Questions and answers on the withdrawal of the marketing application for Aquilda (PDF/36.65 KB)
First published: 09/06/2008
Last updated: 09/06/2008
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.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').