Memantine LEK
memantine
Table of contents
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.
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 and hybrid medicines. |
Publication details | |
---|---|
Marketing-authorisation holder |
Pharmathen S.A.
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
21/04/2013
|
Contact address |
Product information
20/10/2020 Memantine LEK - EMEA/H/C/002630 - IB/0010
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 anti-dementia drugs
Therapeutic indication
Treatment of patients with moderate to severe Alzheimer’s disease.