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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Memantine Merz   
Auth. number : EU/1/12/799
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: Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland
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
26/11/2012 Centralised - Authorisation EMEA/H/C/2711 (2012)8702 of 22/11/2012
25/04/2014 Centralised - Variation EMEA/H/C/2711/WS/562
Updated with Decision(2015)3429 of 13/05/2015
19/05/2015 Centralised - Yearly update (2015)3429 of 13/05/2015
29/07/2015 Centralised - Notification EMEA/H/C/2711/N/7
Updated with Decision(2017)5096 of 13/07/2017
01/12/2015 Centralised - Notification EMEA/H/C/2711/N/9
Updated with Decision(2017)5096 of 13/07/2017
23/01/2017 Centralised - Notification EMEA/H/C/2711/N/11
Updated with Decision(2017)5096 of 13/07/2017
17/07/2017 Centralised - Renewal EMEA/H/C/2711/R/12 (2017)5096 of 13/07/2017