Memantine Mylan

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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 Mylan. It explains how the 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 Mylan.

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

This EPAR was last updated on 16/07/2019

Authorisation details

Product details
Name
Memantine Mylan
Agency product number
EMEA/H/C/002660
Active substance
memantine hydrochloride
International non-proprietary name (INN) or common name
memantine
Therapeutic area (MeSH)
Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
N06DX01
GenericGeneric

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
Mylan S.A.S
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
21/04/2013
Contact address

117 Allee des Parcs
69800 Saint-Priest
France

Product information

13/03/2019 Memantine Mylan - EMEA/H/C/002660 - N/0013

Contents

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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