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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Memantine ratiopharm   

   This product is authorised under a different brand name in the EU in the following languages:
   - Мемантин ratiopharm (BG)
   - Memantin ratiopharm (DE)
   - Memantina ratiopharm (ES)
   - Memantina ratiopharm (IT)
   - Memantina ratiopharm (PT)
   - Memantină ratiopharm (RO)
   - Memantin ratiopharm (SL)
Auth. number : EU/1/13/836
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: ratiopharm GmbH
Graf-Arco-Straße 3, 89079 Ulm, 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
17/06/2013 Centralised - Authorisation EMEA/H/C/2671 (2013)3817 of 13/06/2013
16/12/2013 Centralised - Variation EMEA/H/C/2671/IB/1
Updated with Decision(2015)212 of 15/01/2015
19/01/2015 Centralised - Yearly update (2015)212 of 15/01/2015
14/08/2015 Centralised - Variation EMEA/H/C/2671/IB/4
Updated with Decision(2016)5281 of 09/08/2016
28/06/2016 Centralised - Variation EMEA/H/C/2671/IB/6
Updated with Decision(2016)5281 of 09/08/2016
11/08/2016 Centralised - Yearly update (2016)5281 of 09/08/2016
20/11/2017 Centralised - Variation EMEA/H/C/2671/IAin/13/G
Updated with Decision(2018)2369 of 13/04/2018
17/04/2018 Centralised - Renewal EMEA/H/C/2671/R/11 (2018)2369 of 13/04/2018