Retisert: Withdrawal of the marketing authorisation application
On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005.
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Retisert (PDF/389.52 KB)Adopted
First published: 31/10/2007
Last updated: 31/10/2007
Bausch & Lomb Ireland withdraws its marketing authorisation application for Retisert (PDF/30.41 KB)
First published: 23/07/2007
Last updated: 23/07/2007
Withdrawal letter : Retisert (PDF/32.88 KB)
First published: 16/07/2007
Last updated: 16/07/2007
Questions and answers on the withdrawal of the marketing application for Retisert (PDF/35.19 KB)
First published: 03/09/2007
Last updated: 03/09/2007
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').