Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Brintellix   
Auth. number : EU/1/13/891
Active substance : vortioxetine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06A - Antidepressants
Chemical subgroup: N06AX - Other antidepressants
Chemical substance: N06AX26 - vortioxetine
(See WHO ATC Index)
Indication: Brintellix is indicated for the treatment of major depressive episodes in adults
Marketing Authorisation Holder: H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Danmark
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
20/12/2013 Centralised - Authorisation EMEA/H/C/2717 (2013)9715 of 18/12/2013
7/03/2014 Centralised - Variation EMEA/H/C/2717/IA/1
Updated with Decision(2014)10106 of 16/12/2014
7/03/2014 Centralised - Variation EMEA/H/C/2717/IA/2
Updated with Decision(2014)10106 of 16/12/2014
18/12/2014 PSUSA - Modification EMEA/H/C/2717/PSUV/3 (2014)10106 of 16/12/2014
26/02/2015 Centralised - Variation EMEA/H/C/2717/II/4
Updated with Decision(2016)1288 of 24/02/2016
6/05/2015 Centralised - Variation EMEA/H/C/2717/IB/7
Updated with Decision(2016)1288 of 24/02/2016
17/06/2015 Centralised - Variation EMEA/H/C/2717/IB/8
Updated with Decision(2016)1288 of 24/02/2016
26/02/2016 Centralised - Yearly update (2016)1288 of 24/02/2016
24/05/2016 Centralised - Variation EMEA/H/C/2717/IB/11
Updated with Decision(2017) 187 of 11/01/2017
13/01/2017 PSUSA - Modification EMEA/H/C/2717/PSUSA/10052/201603 (2017) 187 of 11/01/2017
6/12/2017 Centralised - Variation EMEA/H/C/2717/IB/17