Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Marixino   
Auth. number : EU/1/13/820
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: KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
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
06/05/2013 Centralised - Authorisation EMEA/H/C/2658 (2013)2638 of 29/04/2013
08/08/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2658/T/2 (2013)5288 of 05/08/2013
09/08/2013 Centralised - Variation EMEA/H/C/2658/IAin/3
Updated with Decision(2014)6194 of 26/08/2014
28/08/2014 Centralised - Yearly update (2014)6194 of 26/08/2014
19/01/2015 Centralised - Notification EMEA/H/C/2658/N/5
Updated with Decision(2017)3452 of 16/05/2017
11/05/2016 Centralised - Variation EMEA/H/C/2658/IB/8
Updated with Decision(2017)3452 of 16/05/2017
05/04/2017 Centralised - Variation EMEA/H/C/2658/IB/10
Updated with Decision(2018)410 of 18/01/2018
18/05/2017 Centralised - Yearly update (2017)3452 of 16/05/2017
22/01/2018 Centralised - Renewal EMEA/H/C/2658/R/12 (2018)410 of 18/01/2018
06/04/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2658/T/13 (2018)2136 of 04/04/2018