Marixino (previously Maruxa)

RSS

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 Marixino. 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 Marixino.

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

This EPAR was last updated on 08/12/2021

Authorisation details

Product details
Name
Marixino (previously Maruxa)
Agency product number
EMEA/H/C/002658
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
KRKA, d.d.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
28/04/2013
Contact address

Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

06/12/2021 Marixino (previously Maruxa) - EMEA/H/C/002658 - N/0015

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other anti-dementia drugs

Therapeutic indication

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

Assessment history

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