NEXIUM

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, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

Active ingredients

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

1 Esomeprazole magnesium trihydrate
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 about Esomeprazole

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
NEXIUM Gastro-resistant granules Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC
NEXIUM Powder for solution for injection / infusion Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC
NEXIUM Gastro-resistant tablet Medicines & Healthcare Products Regulatory Agency (GB) 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
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)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 11692J, 12283L, 12287Q, 3401B, 8600P, 8601Q, 8886Q
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502302701115216, 502302702111214, 502302703118212, 502302704114210, 502302705110219, 502302706117217, 502305901158215
Country: CA Health Products and Food Branch Identifier(s): 02244521, 02244522, 02300524, 02444712
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 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
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 24.366-1-11-11, 24.367-1-11-11, 26.474-06-05, 28803-04-09
Country: EE Ravimiamet Identifier(s): 1012442, 1012677, 1087938, 1087949, 1087950, 1087961, 1087972, 1087983, 1087994, 1155462, 1155473, 1624025, 1624036, 1747874, 1830574, 1831564, 1831575, 1885215, 1885226
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 3400935533432, 3400935533951, 3400935533951IP, 63436, 63437, 66038, 69980, 84225112-2-12, 842261102022012
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 000362, 000379, 001659, 001980, 014609, 075141, 582717
Country: FR Base de données publique des médicaments Identifier(s): 60357359
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 139369, 143693, 143706, 161167, 196181, 196969, 21546, 21552, 289399, 289400, 355855, 368184, 374162, 380906, 387020, 387244, 389122, 394081
Country: HK Department of Health Drug Office Identifier(s): 48058, 48059, 52131, 57958
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-094630075
Country: IE Health Products Regulatory Authority Identifier(s): 32204, 32216, 32227, 32248, 32275, 36519, 36529, 36541, 36554, 61409, 61470, 61471
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4484, 4485, 6443
Country: IT Agenzia del Farmaco Identifier(s): 034972265, 034972291, 034972416, 034972442
Country: JP 医薬品医療機器総合機構 Identifier(s): 2329029D1027, 2329029D2023, 2329029M1027, 2329029M2023
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 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
Country: MT Medicines Authority Identifier(s): AA770/10502, AA770/10503, AA908/03503, AA908/03504, AA908/03505, AA908/03506
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 106M2001, 158M2008, 518M2003
Country: NG Registered Drug Product Database Identifier(s): 04-4922, A4-6473
Country: NL Z-Index G-Standaard, PRK Identifier(s): 100137, 57851, 57878, 86827
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 20610
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100104535, 100104541, 100131680, 100312021, 100355361, 100355591, 100418156
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W53101001, W68972002, W68972003, W68973002
Country: SG Health Sciences Authority Identifier(s): 11498P, 11499P, 12616P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 24313011, 24313012
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699786040014, 8699786040021, 8699786040038, 8699786040045
Country: US FDA, National Drug Code Identifier(s): 0186-4010, 0186-4020, 0186-4025, 0186-4040, 0186-4050, 0186-5020, 0186-5040, 50090-0742

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