Memantine Accord
Authorised
This medicine is authorised for use in the European Union
memantine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Memantine Accord. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Memantine Accord.
For practical information about using Memantine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Memantine Accord is a medicine that contains the active substance memantine. It is 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.
Memantine Accord is a ‘generic medicine’. This means that Memantine Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Axura.
Memantine Accord is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) 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 Accord by the patient.
Memantine Accord should be given once a day at the same time every day. To prevent side effects, the dose of Memantine Accord is gradually increased over the first three weeks of treatment: during the first week, the daily 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 Accord should be re-assessed on a regular basis. The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
The active substance in Memantine Accord, 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 types of receptors 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. By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer’s disease.
The company provided data on the medicine’s solubility, composition and absorption in the body. No additional studies in patients were required as Memantine Accord was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Axura. ‘Bioequivalent’ means that the medicines are expected to produce the same levels of the active substance in the body.
Because Memantine Accord 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 Accord has been shown to have comparable quality and is considered bioequivalent to Axura. Therefore, the CHMP’s view was that, as for Axura, the benefit outweighs the identified risk. The Committee recommended that Memantine Accord be approved for use in the EU.
A risk management plan has been developed to ensure that Memantine Accord is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Memantine Accord, 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 Accord on 04 December 2013.
For more information about treatment with Memantine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IA/0016
10/01/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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 Accord
- 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
Other anti-dementia drugsTherapeutic indication
Treatment of patients with moderate to severe Alzheimer’s disease.
News on Memantine Accord
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