Memantine LEK

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Withdrawn

This medicine's authorisation has been withdrawn

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European Public Assessment Report (EPAR) for Memantine LEK is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IB/0010
20/10/2020
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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).

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Suomi (FI) (44.56 KB - PDF)

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svenska (SV) (43.89 KB - PDF)

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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

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