Memantine FGK: Withdrawal of the marketing authorisation application

memantine

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
  • memantine
Active substance
  • memantine
Date of withdrawal
18/12/2012
Company making the application
FGK Representative Service GmbH
Withdrawal type
Initial authorisation

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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

How useful was this page?

Add your rating