Duloxetine Sandoz: Withdrawal of the marketing authorisation application
duloxetine
Table of contents
Overview
On 08 April 2015, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Duloxetine Sandoz, for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Key facts
Name |
Duloxetine Sandoz |
Product number |
EMEA/H/C/004009 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
08/04/2015 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Duloxetine Sandoz (PDF/517.47 KB)
First published: 23/06/2015
Last updated: 23/06/2015
EMA/368328/2015 -
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Withdrawal letter: Duloxetine Sandoz (PDF/13.08 KB)
First published: 24/04/2015
Last updated: 24/04/2015 -
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Questions and answers on the withdrawal of the marketing authorisation application for Duloxetine Sandoz (duloxetine) (PDF/72.43 KB)
First published: 24/04/2015
Last updated: 24/04/2015
EMA/249807/2015 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').