CYMBALTA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Duloxetine UNII 9044SC542W - DULOXETINE HYDROCHLORIDE

Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Read about Duloxetine

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
CYMBALTA Hard gastro-resistant capsule	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
N06AX21	Duloxetine	N Nervous system → N06 Psychoanaleptics → N06A Antidepressants → N06AX Other antidepressants
Discover more medicines within N06AX21

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 9155W, 9156X
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 507603304116210, 507603306119314, 507603308111310, 507603310116316, 507612050017103, 507612050017203, 507614060018003, 507620020020607
Country: CA	Health Products and Food Branch	Identifier(s): 02301482, 02301490
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 00104484, 00203559, 00203565, 00203588, 00225325, 00348513, 00363352, 00403531, 00403548, 00429200, 00565009, 00770531, 00770548, 00834159, 00896769, 00896781, 01097007, 01138829, 01852857, 02187669, 02579010, 02582791, 02844423, 03426969, 03427041, 03882503, 04049121, 04165436, 04165442, 04165459, 04866423, 04957611, 04957628, 04965237, 05124511, 05500546, 05500569, 06152254, 06439033, 06439056, 07023990, 07177339, 07355893, 09224008, 09224020, 09241283, 10005234, 10005263, 12502988, 13883840, 14139894, 14139902, 14281474, 15612447, 15612453
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 30266-07-12, 30291-09-12
Country: EE	Ravimiamet	Identifier(s): 1195624, 1195635, 1207639, 1207662, 1207673, 1207684, 1286007, 1286018, 1363665
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 04296001, 04296001IP, 04296002, 04296002IP, 04296002IP1, 04296002IP2, 04296002IP3, 04296002IP4, 04296006
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 021721, 021967
Country: FR	Base de données publique des médicaments	Identifier(s): 66852477, 68263545
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 138590, 138592, 374339, 374341, 90387, 90394
Country: HK	Department of Health Drug Office	Identifier(s): 53843, 53844
Country: IE	Health Products Regulatory Authority	Identifier(s): 19961, 19975, 19990, 19995, 21006, 21010
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4823, 4824
Country: IT	Agenzia del Farmaco	Identifier(s): 036683011, 036683023, 036683062, 047516012
Country: JP	医薬品医療機器総合機構	Identifier(s): 1179052M1022, 1179052M2029
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1004485, 1004486, 1028355, 1028356, 1028357, 1028358, 1028359, 1028360, 1028361
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 211M2004
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 79057, 79065
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100145563, 100145570
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W43297001, W43297002, W43297003, W43298001, W43298002, W43298003, W43298004, W43298005, W43298006
Country: SG	Health Sciences Authority	Identifier(s): 13189P, 13190P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699673170206, 8699673170213
Country: US	FDA, National Drug Code	Identifier(s): 0002-3235, 0002-3240, 0002-3270, 55289-028, 55289-036, 70518-2099
Country: ZA	Health Products Regulatory Authority	Identifier(s): 37/1.2/0299, 37/1.2/0301