Marixino (previously Maruxa)

memantine

  • Email
  • Help

About

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.

What is Marixino and what is it used for?

Marixino is a medicine used to treat patients with moderate to severe Alzheimer’s disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour. It contains the active substance memantine hydrochloride.

Marixino is a ‘generic medicine’. This means that Marixino is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Ebixa.

How is Marixino used?

Marixino is available as 10-mg and 20-mg tablets and can only be obtained with a prescription.

Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease. Treatment should only be started if a caregiver is available who will regularly monitor the use of Marixino by the patient.

Marixino should be given once a day at the same time every day. To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Marixino should be reassessed on a regular basis. The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.

For more information, see the package leaflet.

How does Marixino work?

The active substance in Marixino, memantine, is an antidementia medicine. The cause of Alzheimer’s disease is unknown, but memory loss in the disease is believed to be due to a disturbance of message signals in the brain.

Memantine works by blocking special types of receptor called N-methyl-D-aspartate (NMDA) receptors, to which the neurotransmitter glutamate normally attaches. Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with one another. Changes in the way glutamate transmits signals within the brain have been linked to the memory loss seen in Alzheimer’s disease. In addition, overstimulation of the NMDA receptors may result in cell damage or death. By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer’s disease.

How has Marixino been studied?

The company provided data on the medicine’s solubility, composition and absorption in the body. No additional studies in patients were required as Marixino was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Ebixa. ‘Bioequivalent’ means that the medicines are expected to produce the same levels of the active substance in the body.

What are the benefits and risks of Marixino?

Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Marixino approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa. Therefore, the CHMP’s view was that, as for Ebixa, the benefit outweighs the identified risk. The Committee recommended that Marixino be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Marixino?

Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Marixino

The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013. The name of the medicine was changed to Marixino on 9 August 2013.

For more information about treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Marixino : EPAR - Summary for the public BG = bălgarski 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public ES = español 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public CS = čeština 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public DA = dansk 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public DE = Deutsch 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public ET = eesti keel 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public EL = elliniká 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public EN = English 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public FR = français 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public IT = italiano 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public LV = latviešu valoda 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public LT = lietuvių kalba 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public HU = magyar 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public MT = Malti 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public NL = Nederlands 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public PL = polski 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public PT = português 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public RO = română 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public SK = slovenčina 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public SL = slovenščina 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public FI = suomi 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public SV = svenska 2013-05-21 2013-08-22
Marixino : EPAR - Summary for the public HR = Hrvatski 2013-05-21 2013-08-22

This EPAR was last updated on 13/04/2018 .

Authorisation details

Product details

Product details for Marixino (previously Maruxa)
NameMarixino (previously Maruxa)
Agency product numberEMEA/H/C/002658
Active substance

memantine hydrochloride

International non-proprietary name (INN) or common name

memantine

Therapeutic area Alzheimer Disease
Anatomical therapeutic chemical (ATC) code N06DX01
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Marixino (previously Maruxa)
Marketing-authorisation holder

KRKA, d.d.

Revision6
Date of issue of marketing authorisation valid throughout the European Union29/04/2013

Contact address:

KRKA, d.d., 
Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

04/04/2018  Marixino (previously Maruxa) -EMEA/H/C/002658 -T/0013

Name Language First published Last updated
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13
Marixino: EPAR - Product Information HR = Hrvatski 2013-05-21 2018-04-13

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.


Name Language First published Last updated
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22
Marixino : EPAR - All Authorised presentations HR = Hrvatski 2013-05-21 2013-08-22

Pharmacotherapeutic group

Other antidementia drugs

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Marixino: EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2013-08-22 2018-04-13

Initial marketing-authorisation documents

Name Language First published Last updated
Maruxa : EPAR - Public assessment report HR = Hrvatski 2013-05-21  
CHMP summary of positive opinion for Maruxa HR = Hrvatski 2013-01-18  

Authorised

This medicine is approved for use in the European Union

More information on Marixino