Tygacil: Withdrawal of the application to change the marketing authorisation
Table of contents
On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.
|Date of issue of market authorisation valid throughout the European Union (if applicable)||
|International non-proprietary name (INN) or common name||
|Date of withdrawal||
|Company making the application|
Withdrawal assessment report for Tygacil (PDF/1.15 MB)Adopted
First published: 24/07/2008
Last updated: 24/07/2008
Wyeth withdraws its application to extend the marketing authorisation for Tygacil (PDF/24.9 KB)
First published: 24/04/2008
Last updated: 24/04/2008
Withdrawal letter : Tygacil (PDF/320.75 KB)
First published: 22/04/2008
Last updated: 22/04/2008
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Tygacil (PDF/32.71 KB)
First published: 30/05/2008
Last updated: 30/05/2008
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').