Prandin: Withdrawal of the application to change the marketing authorisation
repaglinide
Table of contents
Overview
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.
Key facts
Name |
Prandin |
Product number |
EMEA/H/C/000362 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
29/01/2001 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
12/10/2006 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Prandin (PDF/151.83 KB)
Adopted
First published: 14/12/2006
Last updated: 14/12/2006
EMEA/CHMP/511690/2006 -
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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
EMEA/410100/2006 -
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Withdrawal letter : NovoNorm/Prandin (PDF/20.69 KB)
First published: 12/10/2006
Last updated: 12/10/2006 -
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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
EMEA/405238/2006 -