Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Nemdatine   
Auth. number : EU/1/13/824
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: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
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/2680 (2013)2407 of 22/04/2013
08/10/2013 Centralised - Variation EMEA/H/C/2680/IAIN/1
Updated with Decision(2014)8519 of 11/11/2014
13/11/2014 Centralised - Yearly update (2014)8519 of 11/11/2014
24/04/2015 Centralised - Variation EMEA/H/C/2680/IAIN/2/G
Updated with Decision(2016)2279 of 13/04/2016
17/07/2015 Centralised - Variation EMEA/H/C/2680/IB/3
Updated with Decision(2016)2279 of 13/04/2016
13/04/2016 Centralised - Variation EMEA/H/C/2680/IAIN/4
Updated with Decision(2017)2407 of 24/03/2017
15/04/2016 Centralised - Yearly update (2016)2279 of 13/04/2016
06/07/2016 Centralised - Notification EMEA/H/C/2680/N/6
Updated with Decision(2017)2407 of 24/03/2017
28/03/2017 Centralised - Yearly update (2017)2407 of 24/03/2017
14/06/2017 Centralised - Notification EMEA/H/C/2680/N/7
Updated with Decision(2018)129 of 08/01/2018
10/01/2018 Centralised - Renewal EMEA/H/C/2680/R/8 (2018)129 of 08/01/2018