Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: ABILIFY MAINTENA   
Auth. number : EU/1/13/882
Active substance : Aripiprazole
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AX - Other antipsychotics
Chemical substance: N05AX12 - Aripiprazole
(See WHO ATC Index)
Indication: ABILIFY MAINTENA is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole
Marketing Authorisation Holder: Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, 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
19/11/2013 Centralised - Authorisation EMEA/H/C/2755 (2013)8163 of 15/11/2013
28/03/2014 Centralised - Variation
Updated with Decision(2015)2895 of 24/04/2015
23/06/2014 Centralised - Notification EMEA/H/C/2755/N/5
Updated with Decision(2015)2895 of 24/04/2015
17/12/2014 Centralised - Variation EMEA/H/C/2755/IB/10
Updated with Decision(2015)2895 of 24/04/2015
22/01/2015 Centralised - Variation EMEA/H/C/2755/II/12/G
Updated with Decision(2015)2895 of 24/04/2015
25/03/2015 Centralised - Variation EMEA/H/C/2755/IA/15/G
26/03/2015 Centralised - Variation EMEA/H/C/2755/II/11/G
28/04/2015 PSUSA - Modification EMEA/H/C/2755/PSUSA/234 (2015)2895 of 24/04/2015
19/06/2015 Centralised - Variation EMEA/H/C/2755/IB/16/G