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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Memantine Accord   

   This product is authorised under a different brand name in the EU in the following languages:
   - Мемантин Accord (BG)
   - Memantin Accord (DA)
   - Memantin Accord (DE)
   - Memantina Accord (ES)
   - Memantin Accord (HR)
   - Memantina Accord (IT)
   - Memantina Accord (PT)
   - Memantin Accord (SL)
Auth. number : EU/1/13/880
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: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
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
06/12/2013 Centralised - Authorisation EMEA/H/C/2766 (2013)8896 of 04/12/2013
31/03/2014 Centralised - Variation EMEA/H/C/2766/IB/1/G
Updated with Decision(2015)1306 of 19/02/2015
04/12/2014 Centralised - Variation EMEA/H/C/2766/IAin/2/G
Updated with Decision(2015)1306 of 19/02/2015
23/02/2015 Centralised - Yearly update (2015)1306 of 19/02/2015
10/08/2016 Centralised - Variation EMEA/H/C/2766/IAin/6/G
Updated with Decision(2017)4994 of 10/07/2017
12/07/2017 Centralised - Yearly update (2017)4994 of 10/07/2017
08/08/2017 Centralised - Variation EMEA/H/C/2766/IB/9