VALDOXAN

This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Spain, Turkey, UK.

Active ingredients

The drug VALDOXAN contains one active pharmaceutical ingredient (API):

1	Agomelatine UNII 137R1N49AD - AGOMELATINE
	Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
	Read more about Agomelatine

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
VALDOXAN Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
N06AX22	Agomelatine	N Nervous system → N06 Psychoanaleptics → N06A Antidepressants → N06AX Other antidepressants
Discover more medicines within N06AX22

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	531302301110312, 531302302117310, 531318110008903
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	06935192, 06935200, 07338914, 07697843, 07697866, 08922615, 08922621, 09003879, 09003885, 09435142, 09435159, 09505693, 09505701, 09928838, 09928844, 10006280, 10356123, 10356146, 11027315, 13424658, 13424670, 15570743, 16151362
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	5988-MAE-02-11
EE	Ravimiamet	1412312, 1412323, 1412334, 1412345, 1412356, 1412367, 1412378, 1412389
ES	Centro de información online de medicamentos de la AEMPS	08499003, 08499003IP, 08499003IP1, 08499008
FI	Lääkealan turvallisuus- ja kehittämiskeskus	029078, 032534, 571804
FR	Base de données publique des médicaments	67218369
GB	Medicines & Healthcare Products Regulatory Agency	154578, 375368, 381725
HK	Department of Health Drug Office	59904
IE	Health Products Regulatory Authority	51203, 51204, 51206, 51210
IT	Agenzia del Farmaco	039143019, 039143021, 039143033, 039143045, 039143058, 039143060, 039143072, 039143084
LT	Valstybinė vaistų kontrolės tarnyba	1037134, 1037135, 1037136, 1037137, 1037138, 1037139, 1037140
NL	Z-Index G-Standaard, PRK	90824
PL	Rejestru Produktów Leczniczych	100206164
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W54341001, W54341002, W54341003, W54341004, W54341005, W54341006, W54341007, W54341008
SG	Health Sciences Authority	13770P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699552090717