NovoNorm: Withdrawal of the application to change the marketing authorisation
Table of contents
On 12 October 2006, Novo Nordisk A/S officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for NovoNorm/Prandin, to add the use of NovoNorm/Prandin in combination with a thiazolidinedione for the treatment of type 2 diabetes.
|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 NovoNorm (PDF/152.6 KB)Adopted
First published: 14/12/2006
Last updated: 14/12/2006
Novo Nordisk withdraws its application to extend the marketing authorisations for NovoNorm and Prandin (PDF/28.8 KB)
First published: 13/10/2006
Last updated: 13/10/2006
Withdrawal letter : NovoNorm/Prandin (PDF/20.69 KB)
First published: 12/10/2006
Last updated: 12/10/2006
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for NovoNorm/Prandin (PDF/42.39 KB)
First published: 18/10/2006
Last updated: 18/10/2006
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').