Skip to content

Sign in Start free

Create your free account

Loading your page…

We care for the people who care.

No ads. No selling of your data. No third-party trackers.

Apps

Prognia
Ward
Suture
Osler

Library

Guidelines
Medicines
Articles
Calculators
Explore decks
Institutions
Pharmaceutical companies
Blog

Prognia

About
Pricing
Contact

Support us

Founders Wall

© 2026 Prognia · Amsterdam, the NetherlandsPrivacy TermsExchangeRate-API

Loading…

Medicines
Spain
Agomelatine

AEMPS 2009

Agomelatine

Valdoxan 25 MG Comprimidos Recubiertos con Pelicula

25 mg comprimido recubierto con películaSpainAuthorisedAuthorised 8 Mar 2009

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

ValdoxanBrazil · Laboratórios Servier do Brasil LtdaSame brand
ValdoxanEuropean Union · Les Laboratoires ServierSame brand
ValdoxanEuropean Union · Les Laboratoires ServierSame brand
ValdoxanCroatiaSame brand
ValdoxanItaly · Compressa rivestita con film · Les Laboratoires ServierSame brand
Valdoxan 25 mg, filmomhulde tabletNetherlands · Filmomhulde tablet · Les Laboratoires ServierSame brand
VALDOXAN 25mgRomania · 25mg · compr. film. · Les Laboratoires ServierSame brand

More with the same substance on this register

Valdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con películaSpain
Valdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con película

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Valdoxan 25MG Film Coated TabletSaudi Arabia · Servier

Same brand

🇸🇬VALDOXAN Tablet 25mgSingapore · 25 mg · tablet, film coated · Servier (S) Pte LTDSame brand

🇳🇱Agomaval 25 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Krka d.d., Novo mestoSame form

🇳🇱Agomelatine Accord 25 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare B.V.Same form

🇷🇸MelaxinSerbia · 25mg · film tableta · Adoc D.O.O. BeogradSame form

🇷🇸MelaxinSerbia · 25mg · film tableta · Adoc D.O.O. BeogradSame form

🇷🇸Mentela®Serbia · 25mg · film tableta · Hemofarm Ad VRŠAcSame form

🇧🇷agomelatinaBrazil · Teva Farmacêutica Ltda.Same substance

🇧🇷agomelatinaBrazil · Ems S/ASame substance

🇪🇺ThymanaxEuropean Union · Les Laboratoires ServierSame substance

🇭🇷ThymanaxCroatiaSame substance

Packs

Pack	Code	Status
VALDOXAN 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA, 100 comprimidos	602848

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Agomelatine
Strength: 25 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 8 Mar 2009
Registration: 08499008
Marketing authorisation holder: Les Laboratoires Servier
Procedure: EU centralised
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸Spain

AEMPSValdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con película🇪🇸Spain

AEMPSValdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con película🇪🇸Spain

AEMPSValdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con película🇪🇸Spain

AEMPSValdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con película🇪🇸Spain

AEMPSValdoxan 25 MG Comprimidos Recubiertos con PeliculaAgomelatine · 25 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAgomelatina Viso Farmaceutica 25 MG Comprimidos Recubiertos con Pelicula EfgAgomelatine · 25 mg · comprimido recubierto con película🇪🇸SpainWithdrawn

AEMPSTHYMANAX 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULAAgomelatine · 25 mg · comprimido recubierto con película🇪🇸SpainWithdrawn

AEMPSTHYMANAX 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULAAgomelatine · 25 mg · comprimido recubierto con película🇪🇸SpainWithdrawn