Valdoxan

Les Laboratoires Servier,50, rue Carnot,F-92284 Suresnes Cedex,France🇪🇺 European Union

EMA Page

Authorised Date: Feb 19, 2009
Approval ID: a8c2a11eed4e7102
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Valdoxan. 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 Valdoxan. For practical information about using Valdoxan, 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

N06AX22

ATC Item

agomelatine

Pharmacotherapeutic Group

Psychoanaleptics

Active Substances

Active Substance (Summary)

Agomelatine

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
agomelatine	N/A	阿戈美拉汀
Agomelatine	N/A	阿戈美拉汀

Quick Info

Approval IDa8c2a11eed4e7102

Product NumberN/A

StatusAuthorised

Authorised DateFeb 19, 2009

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Valdoxan

Medicine Name

Valdoxan

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.

Back to EMA Approvals