Repaglinide Sun: Withdrawal of the marketing authorisation application
repaglinide
Table of contents
Overview
On 23 March 2010, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Repaglinide Sun for the treatment of type 2 diabetes.
Key facts
Name |
Repaglinide Sun |
Product number |
EMEA/H/C/001145 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
25/03/2010 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Repaglinide Sun (PDF/90.08 KB)
Adopted
First published: 15/06/2010
Last updated: 15/06/2010
EMA/316506/2010 -
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Withdrawal letter : Repaglinide Sun (PDF/30.19 KB)
First published: 28/04/2010
Last updated: 28/04/2010 -
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Questions and answers on the withdrawal of the marketing authorisation application for Repaglinide Sun (repaglinide) (PDF/51.48 KB)
First published: 28/04/2010
Last updated: 28/04/2010
EMA/211132/2010 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').