CYMBALTA

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

Active ingredients

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

1
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 more about Duloxetine

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 CYMBALTA Hard gastro-resistant capsule 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
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)
AU Pharmaceutical Benefits Scheme 9155W, 9156X
BR Câmara de Regulação do Mercado de Medicamentos 507603304116210, 507603306119314, 507603308111310, 507603310116316, 507612050017103, 507612050017203, 507614060018003, 507620020020607
CA Health Products and Food Branch 02301482, 02301490
DE Bundesinstitut für Arzneimittel und Medizinprodukte 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
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 30266-07-12, 30291-09-12
EE Ravimiamet 1195624, 1195635, 1207639, 1207662, 1207673, 1207684, 1286007, 1286018, 1363665
ES Centro de información online de medicamentos de la AEMPS 04296001, 04296001IP, 04296002, 04296002IP, 04296002IP1, 04296002IP2, 04296002IP3, 04296002IP4, 04296006
FI Lääkealan turvallisuus- ja kehittämiskeskus 021721, 021967
FR Base de données publique des médicaments 66852477, 68263545
GB Medicines & Healthcare Products Regulatory Agency 138590, 138592, 374339, 374341, 90387, 90394
HK Department of Health Drug Office 53843, 53844
IE Health Products Regulatory Authority 19961, 19975, 19990, 19995, 21006, 21010
IL מִשְׂרַד הַבְּרִיאוּת 4823, 4824
IT Agenzia del Farmaco 036683011, 036683023, 036683062, 047516012
JP 医薬品医療機器総合機構 1179052M1022, 1179052M2029
LT Valstybinė vaistų kontrolės tarnyba 1004485, 1004486, 1028355, 1028356, 1028357, 1028358, 1028359, 1028360, 1028361
MX Comisión Federal para la Protección contra Riesgos Sanitarios 211M2004
NL Z-Index G-Standaard, PRK 79057, 79065
PL Rejestru Produktów Leczniczych 100145563, 100145570
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W43297001, W43297002, W43297003, W43298001, W43298002, W43298003, W43298004, W43298005, W43298006
SG Health Sciences Authority 13189P, 13190P
TR İlaç ve Tıbbi Cihaz Kurumu 8699673170206, 8699673170213
US FDA, National Drug Code 0002-3235, 0002-3240, 0002-3270, 55289-028, 55289-036, 70518-2099
ZA Health Products Regulatory Authority 37/1.2/0299, 37/1.2/0301

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