Diractin: Withdrawal of the marketing authorisation application
On 23 July 2008, IDEA AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Diractin, for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Diractin (PDF/296.96 KB)Adopted
First published: 28/11/2008
Last updated: 28/11/2008
Idea AG withdraws its marketing authorisation application for Diractin (ketoprofen) (PDF/19.29 KB)
First published: 24/07/2008
Last updated: 24/07/2008
Withdrawal letter : Diractin (PDF/29.24 KB)
First published: 23/07/2008
Last updated: 23/07/2008
Questions and answers on the withdrawal of the marketing application for Diractin (PDF/38.76 KB)
First published: 21/08/2008
Last updated: 21/08/2008
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').