- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 6 September 2024, the European Commission withdrew the marketing authorisation for Memantine LEK (memantine hydrochloride) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Pharmathen S.A., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Memantine LEK was granted marketing authorisation in the EU on 22 April 2013 for the treatment of Alzheimer’s disease. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2018.
Memantine LEK is a generic medicine of Ebixa. There are other generic medicinal products of Ebixa authorised and marketed in the EU. The European Public Assessment Report (EPAR) for Memantine LEK is updated to indicate that the marketing authorisation is no longer valid.
Product information
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 LEK
- 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.