NovoSeven: Withdrawal of the application to change the marketing authorisation
eptacog alfa (activated)
Table of contents
On 3 April 2006, Novo Nordisk A/S has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for NovoSeven, in the treatment of acute intracerebral haemorrhage (ICH) in adults for limiting haemorrhage growth and improving clinical outcome.
|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|
Novo Nordisk withdraw their application to extend the marketing authorisation for NovoSeven (PDF/29.91 KB)
First published: 06/04/2006
Last updated: 06/04/2006
Withdrawal letter : NovoSeven (PDF/19.66 KB)
First published: 03/04/2006
Last updated: 03/04/2006
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for NovoSeven (PDF/35.33 KB)
First published: 27/04/2006
Last updated: 27/04/2006
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').