NEXIUM

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, Malta, Mexico, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII R6DXU4WAY9 - ESOMEPRAZOLE MAGNESIUM
 

Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H+ K+ -ATPase – the acid pump and inhibits both basal and stimulated acid secretion.

 
Read more about Esomeprazole

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 NEXIUM Gastro-resistant granules MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)
 NEXIUM Gastro-resistant tablet MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)
 NEXIUM Powder for solution for injection / infusion MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group Classification
A02BC05 Esomeprazole A Alimentary tract and metabolism → A02 Drugs for acid related disorders → A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) → A02BC Proton pump inhibitors
Discover more medicines within A02BC05

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 11692J, 12283L, 12287Q, 3401B, 8600P, 8601Q, 8886Q
BR Câmara de Regulação do Mercado de Medicamentos 502302701115216, 502302702111214, 502302703118212, 502302704114210, 502302705110219, 502302706117217, 502305901158215
CA Health Products and Food Branch 02244521, 02244522, 02300524, 02444712
DE Bundesinstitut für Arzneimittel und Medizinprodukte 01340040, 01340086, 01340117, 01340123, 01340152, 01340175, 01340181, 01340198, 01743370, 01949344, 01949367, 01949410, 01949433, 01949462, 01949485, 07099421, 07099527, 07156515, 07156797, 07161657, 07161663, 07789054, 07789060, 07789077, 07789083, 09309176, 09309199, 09423222, 09423245, 09423268, 09423274, 09434728, 09510599, 09510613, 09510636, 09529297, 09529305, 09695452, 09709929, 09709935, 09709941, 09709958, 09713210, 09713227, 09713233, 10183823, 10183846, 11048719, 11048731, 11111582, 11111872, 11111926, 11111949, 11111961, 11111978, 12422858, 12422930, 12422947, 12599901, 12599918, 12599924, 12599930, 12599947, 12599953, 13833256, 14211864, 14238768, 14360877, 14360883, 14360908, 15193252, 15193424, 15196523, 15266258, 15266264, 16385539, 16385545, 17448176, 17448182, 17883512, 17883529, 17883541, 17883558, 17883564, 17883570
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 24.366-1-11-11, 24.367-1-11-11, 26.474-06-05, 28803-04-09
EE Ravimiamet 1012442, 1012677, 1087938, 1087949, 1087950, 1087961, 1087972, 1087983, 1087994, 1155462, 1155473, 1624025, 1624036, 1747874, 1830574, 1831564, 1831575, 1885215, 1885226
ES Centro de información online de medicamentos de la AEMPS 3400935533432, 3400935533951, 3400935533951IP, 63436, 63437, 66038, 69980, 84225112-2-12, 842261102022012
FI Lääkealan turvallisuus- ja kehittämiskeskus 000362, 000379, 001659, 001980, 014609, 075141, 582717
FR Base de données publique des médicaments 60357359
GB Medicines & Healthcare Products Regulatory Agency 139369, 143693, 143706, 161167, 196181, 196969, 21546, 21552, 289399, 289400, 355855, 368184, 374162, 380906, 387020, 387244, 389122, 394081
HK Department of Health Drug Office 48058, 48059, 52131, 57958
HR Agencija za lijekove i medicinske proizvode HR-H-094630075
IE Health Products Regulatory Authority 32204, 32216, 32227, 32248, 32275, 36519, 36529, 36541, 36554, 61409, 61470, 61471
IL מִשְׂרַד הַבְּרִיאוּת 4484, 4485, 6443
IT Agenzia del Farmaco 034972265, 034972291, 034972416, 034972442
JP 医薬品医療機器総合機構 2329029D1027, 2329029D2023, 2329029M1027, 2329029M2023
LT Valstybinė vaistų kontrolės tarnyba 1008011, 1008012, 1015573, 1015574, 1017783, 1017784, 1020283, 1020284, 1027345, 1071163, 1071164, 1072645, 1072646, 1073764, 1073847, 1073848, 1074042, 1077707, 1079155, 1079274, 1081428, 1081766, 1084002, 1084003, 1084595, 1084596, 1084827, 1084828, 1085243, 1085576, 1085577, 1085583, 1086331, 1086736, 1086774, 1086872, 1087053, 1087694, 1088048, 1088286, 1088502, 1088503, 1089898, 1089911, 1089912, 1090088, 1090216, 1090340, 1090793, 1090794, 1091296
MT Medicines Authority AA770/10502, AA770/10503, AA908/03503, AA908/03504, AA908/03505, AA908/03506
MX Comisión Federal para la Protección contra Riesgos Sanitarios 106M2001, 158M2008, 518M2003
NG Registered Drug Product Database 04-4922, A4-6273, A4-6473
Switch country to Nigeria in order to find specific presentations of NEXIUM
NL Z-Index G-Standaard, PRK 100137, 57851, 57878, 86827
NZ Medicines and Medical Devices Safety Authority 20610
PL Rejestru Produktów Leczniczych 100104535, 100104541, 100131680, 100312021, 100355361, 100355591, 100418156
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W53101001, W68972002, W68972003, W68973002
SG Health Sciences Authority 11498P, 11499P, 12616P
TN Direction de la Pharmacie et du Médicament 24313011, 24313012
TR İlaç ve Tıbbi Cihaz Kurumu 8699786040014, 8699786040021, 8699786040038, 8699786040045
US FDA, National Drug Code 0186-4010, 0186-4020, 0186-4025, 0186-4040, 0186-4050, 0186-5020, 0186-5040, 50090-0742

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