VALDOXAN

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

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 about Agomelatine

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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