Memantine LEK

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memantine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Memantine LEK. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Memantine LEK.

For practical information about using Memantine LEK, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 02/02/2018

Authorisation details

Product details
Name
Memantine LEK
Agency product number
EMEA/H/C/002630
Active substance
memantine hydrochloride
International non-proprietary name (INN) or common name
memantine
Therapeutic area (MeSH)
Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
N06DX01
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic medicines.

Publication details
Marketing-authorisation holder
Pharmathen S.A.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
22/04/2013
Contact address
6, Dervenakion str.
15351 Pallini
Attiki
Greece

Product information

08/01/2018 Memantine LEK - EMEA/H/C/002630 - R/0009

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

  • PSYCHOANALEPTICS
  • other antidementia drugs

Therapeutic indication

Treatment of patients with moderate to severe Alzheimer’s disease.

Assessment history

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