Memantine FGK: Withdrawal of the marketing authorisation application
memantine
Table of contents
Overview
On 10 January 2013, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Memantine FGK, for the treatment of patients with moderate to severe Alzheimer's disease.
Key facts
Name |
Memantine FGK |
Product number |
EMEA/H/C/002687 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
18/12/2012 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Memantine FGK (PDF/904.26 KB)
Adopted
First published: 10/04/2013
Last updated: 10/04/2013
EMA/17269/2013 -
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Withdrawal letter: Memantine FGK (PDF/127.3 KB)
First published: 18/01/2013
Last updated: 25/01/2013 -
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FGK Representative Service GmbH withdraws its marketing authorisation application for Memantine FGK (memantine) (PDF/69.41 KB)
First published: 11/01/2013
Last updated: 11/01/2013
EMA/18787/2013 -
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Questions and answers on the withdrawal of the marketing-authorisation application for Memantine FGK (PDF/75.33 KB)
First published: 18/01/2013
Last updated: 10/04/2013
EMA/19257/2013 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').