The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail


25 milligram(s) Film-coated tablet

Les Laboratoires ServierEU/1/08/499/1-8

Main Information

Trade NameValdoxan
Active SubstancesAgomelatine
Strength25 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderLes Laboratoires Servier
Licence NumberEU/1/08/499/1-8

Group Information

ATC CodeN06AX Other antidepressants
N06AX22 agomelatine


Licence Issued
Legal statusNot applicable
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing Status


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

« Back