Memantine Mylan（美金刚）EPAR 更新：欧盟已批准用于中重度阿尔茨海默病

Application under evaluation
CHMP opinion
European Commission decision

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.

Memantine Mylan 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.

Memantine Mylan is a ‘generic medicine’. This means that Memantine Mylan is similar to a ‘reference medicine’ already authorised in the EU called Ebixa.

Memantine Mylan 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 Memantine Mylan by the patient.

Memantine Mylan should be given once a day at the same time every day. To prevent side effects, the dose of Memantine Mylan 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 Memantine Mylan 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.

The active substance in Memantine Mylan, 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.

Because Memantine Mylan is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because Memantine Mylan 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.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine Mylan 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 Memantine Mylan be approved for use in the EU.

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

The European Commission granted a marketing authorisation valid throughout the European Union for Memantine Mylan on 22 April 2013.

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

Product information

Latest procedure affecting product information:VR/0000370777

28/10/2026

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This medicine’s product information is available in all official EU languages.
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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).

Product details

Name of medicine: Memantine Mylan
Active substance: memantine hydrochloride
International non-proprietary name (INN) or common name: memantine
Therapeutic area (MeSH): Alzheimer Disease
Anatomical therapeutic chemical (ATC) code: N06DX01

Pharmacotherapeutic group

Psychoanaleptics
Other anti-dementia drugs

Therapeutic indication

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

EMA product number

EMEA/H/C/002660

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.

Marketing authorisation holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Marketing authorisation issued

21/04/2013

Revision

More information on Memantine Mylan

This page was last updated on 28/10/2026