Brintellix

H. Lundbeck A/S,Ottiliavej 9,DK-2500 Valby,Denmark🇪🇺 European Union

EMA Page

Authorised Date: Dec 18, 2013
Approval ID: f8a05be82c451404
Products: 3 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Brintellix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Brintellix. For practical information about using Brintellix, patients should read the package leaflet or contact their doctor or pharmacist.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Treatment of major depressive episodes in adults.

Therapeutic Area (MeSH)

N/A

ATC Code

N06AX26

ATC Item

vortioxetine

Pharmacotherapeutic Group

Psychoanaleptics

Active Substances

Active Substance (Summary)

Vortioxetine

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
vortioxetine	N/A	沃替西汀
Vortioxetine	N/A	沃替西汀

Quick Info

Approval IDf8a05be82c451404

Product NumberN/A

StatusAuthorised

Authorised DateDec 18, 2013

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Brintellix

Medicine Name

Brintellix

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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