Memantine LEK

Withdrawn

This medicine's authorisation has been withdrawn

memantine

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European Public Assessment Report (EPAR) for Memantine LEK is updated to indicate that the marketing authorisation is no longer valid.

Memantine LEK : EPAR - Summary for the public

Reference Number: EMA/136423/2013

Product information

Memantine LEK : EPAR - Product Information

Memantine LEK : EPAR - All Authorised presentations

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002630
• 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:
  Pharmathen S.A.

  6, Dervenakion str.; 15351 Pallini; Attiki; Greece

• Opinion adopted:
  21/02/2013
• Marketing authorisation issued:
  21/04/2013
• Withdrawal of marketing authorisation:
  06/09/2024
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Memantine LEK : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Memantine LEK : EPAR - Public assessment report

AdoptedReference Number: EMA/227468/2013

CHMP summary of positive opinion for Memantine LEK

AdoptedReference Number: EMA/CHMP/82409/2013