Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

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.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
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/0002/G