Ebixa

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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 Ebixa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ebixa.

This EPAR was last updated on 06/02/2019

Authorisation details

Product details
Name
Ebixa
Agency product number
EMEA/H/C/000463
Active substance
memantine hydrochloride
International non-proprietary name (INN) or common name
memantine
Therapeutic area (MeSH)
Alzheimer Disease
Anatomical therapeutic chemical (ATC) code
N06DX01
Publication details
Marketing-authorisation holder
H. Lundbeck A/S
Revision
25
Date of issue of marketing authorisation valid throughout the European Union
15/05/2002
Contact address
Ottiliavej 9
DK-2500 Valby
Denmark

Product information

22/01/2019 Ebixa - EMEA/H/C/000463 - IB/0089

Contents

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Pharmacotherapeutic group

other antidementia drugs

Therapeutic indication

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

Assessment history

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