JARDIANCE

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

Active ingredients

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

1
UNII HDC1R2M35U - EMPAGLIFLOZIN
 

Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2). Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption.

 
Read more about Empagliflozin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 JARDIANCE Film-coated tablet 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
A10BK03 A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10B Blood glucose lowering drugs, excl. insulins → A10BK Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Discover more medicines within A10BK03

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 10202Y, 10206E, 11281R, 11314L
BR Câmara de Regulação do Mercado de Medicamentos 504514110019702, 504514110019802, 504514110019902, 504514110020002
CA Health Products and Food Branch 02443937, 02443945
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 630-MEE-0115, 631-MEE-0115
EE Ravimiamet 1648964, 1648975, 1648986, 1648997, 1649000, 1649011, 1649022, 1649033, 1649044, 1649099, 1649101, 1649112, 1649123, 1649134, 1649145, 1649156, 1649167, 1649178
ES Centro de información online de medicamentos de la AEMPS 114930005, 114930014
FI Lääkealan turvallisuus- ja kehittämiskeskus 106581, 110972, 526918, 541084
FR Base de données publique des médicaments 67947145, 69963066
GB Medicines & Healthcare Products Regulatory Agency 252389, 252401, 368047, 368050, 374409, 374410, 374412, 374413, 376687, 381422, 381423, 381425, 381426
HK Department of Health Drug Office 64095, 64096
IE Health Products Regulatory Authority 13256, 13257
IL מִשְׂרַד הַבְּרִיאוּת 7596, 7597
IT Agenzia del Farmaco 043443011, 043443023, 043443035, 043443047, 043443050, 043443062, 043443074, 043443086, 043443098, 043443100, 043443112, 043443124, 043443136, 043443148, 043443151, 043443163, 043443175, 043443187
JP 医薬品医療機器総合機構 3969023F1023, 3969023F2020
LT Valstybinė vaistų kontrolės tarnyba 1071137, 1072776, 1073470, 1073471, 1073472, 1073473, 1073474, 1073475, 1073476, 1073477, 1073480, 1073481, 1073482, 1073483, 1073484, 1073485, 1073486, 1073487
NG Registered Drug Product Database C4-0225, C4-0226
Switch country to Nigeria in order to find specific presentations of JARDIANCE
NL Z-Index G-Standaard, PRK 119407, 119415
NZ Medicines and Medical Devices Safety Authority 16935, 16948
PL Rejestru Produktów Leczniczych 100315976, 100315982
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W60940001, W60940002, W60940003, W60941001, W60941002, W60941003
SG Health Sciences Authority 14686P, 14687P
TN Direction de la Pharmacie et du Médicament 11533071, 11533072
TR İlaç ve Tıbbi Cihaz Kurumu 8699693090119, 8699693090126
US FDA, National Drug Code 0597-0152, 0597-0153, 50090-4384, 50090-4492, 55154-0411, 55154-0412, 70518-1986, 70518-2447, 71610-177
ZA Health Products Regulatory Authority 48/21.2/0411, 48/21.2/1380

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