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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Memantine LEK   

   This product is authorised under a different brand name in the EU in the following languages:
   - Мемантин LEK (BG)
   - Memantin LEK (DE)
   - Memantina LEK (PT)
   - Memantin LEK (SL)
Auth. number : EU/1/13/826
Active substance : Memantine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06D - Anti-dementia drugs
Chemical subgroup: N06DX - Other anti-dementia drugs
Chemical substance: N06DX01 - memantine
(See WHO ATC Index)
Indication: Treatment of patients with moderate to severe Alzheimer’s disease.
Marketing Authorisation Holder: Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/04/2013 Centralised - Authorisation EMEA/H/C/2630 (2013)2405 of 22/04/2013
24/05/2013 Centralised - Variation EMEA/H/C/2630/IAin/2/G
Updated with Decision(2014)3825 of 03/06/2014
24/06/2013 Centralised - Variation EMEA/H/C/2630/IB/1
Updated with Decision(2014)3825 of 03/06/2014
24/06/2013 Centralised - Variation EMEA/H/C/2630/IB/3/G
Updated with Decision(2014)3825 of 03/06/2014
24/04/2014 Centralised - Notification EMEA/H/C/2630/N/5
Updated with Decision(2014)3825 of 03/06/2014
05/06/2014 Centralised - Yearly update (2014)3825 of 03/06/2014
28/06/2016 Centralised - Variation EMEA/H/C/2630/IB/8
Updated with Decision(2017)3753 of 24/05/2017
31/05/2017 Centralised - Yearly update (2017)3753 of 24/05/2017
10/01/2018 Centralised - Renewal EMEA/H/C/2630/R/9 (2018)131 of 08/01/2018