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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Memantine Mylan   

   This product is authorised under a different brand name in the EU in the following languages:
   - Мемантин Mylan (BG)
   - Memantin Mylan (CS)
   - Memantin Mylan (DE)
   - Memantina MYLAN (ES)
   - Memantina Mylan (IT)
   - Memantina Mylan (PT)
   - Memantina Mylan (RO)
   - Memantin Mylan (SK)
   - Memantin Mylan (SL)
Auth. number : EU/1/13/827
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: Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, 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
24/04/2013 Centralised - Authorisation EMEA/H/C/2660 (2013)2404 of 22/04/2013
23/06/2015 Centralised - Variation EMEA/H/C/2660/IB/2
Updated with Decision(2016)4185 of 29/06/2016
8/07/2016 Centralised - Yearly update (2016)4185 of 29/06/2016
17/01/2017 Centralised - Variation EMEA/H/C/2660/IB/8
Updated with Decision(2018)132 of 08/01/2018
15/01/2018 Centralised - Renewal EMEA/H/C/2660/R/10 (2018)132 of 8/01/2018