FORXIGA

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

Active ingredients

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

1
UNII 887K2391VH - DAPAGLIFLOZIN PROPANEDIOL
 

Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion.

 
Read more about Dapagliflozin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 FORXIGA 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
A10BK01 Dapagliflozin 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 A10BK01

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 10011X, 11291G
BR Câmara de Regulação do Mercado de Medicamentos 502317100031917, 502317100032017, 502317100032117, 505113120021102
CA Health Products and Food Branch 02435462, 02435470
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 4302-MEE-0718
EE Ravimiamet 1598597, 1598609, 1598610, 1598621, 1598632, 1598643, 1598654, 1598665, 1598676, 1598687
ES Centro de información online de medicamentos de la AEMPS 112795007
FI Lääkealan turvallisuus- ja kehittämiskeskus 041140, 492107, 507959, 596876
FR Base de données publique des médicaments 67456363
GB Medicines & Healthcare Products Regulatory Agency 216096, 216099, 368932, 368933, 374376, 374377, 374379, 376656, 376657, 379893, 381356, 381358, 381359, 389124
HK Department of Health Drug Office 63301, 63302
IE Health Products Regulatory Authority 18921, 18954
IL מִשְׂרַד הַבְּרִיאוּת 7585
JP 医薬品医療機器総合機構 3969019F1027, 3969019F2023
LT Valstybinė vaistų kontrolės tarnyba 1068363, 1068364, 1068365, 1068366, 1068367, 1068368, 1068369, 1068370, 1068371, 1068372, 1091484
MX Comisión Federal para la Protección contra Riesgos Sanitarios 049M2013
NL Z-Index G-Standaard, PRK 104760, 104779
NZ Medicines and Medical Devices Safety Authority 15029
PL Rejestru Produktów Leczniczych 100279418, 100279424
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W62286001, W62286002, W62286003, W62286004, W62286005, W65166001, W65166002, W65166003, W65166004, W65166005
SG Health Sciences Authority 14541P, 14542P
TN Direction de la Pharmacie et du Médicament 8233071, 8233072
ZA Health Products Regulatory Authority 46/21.2/0214, 46/21.2/0215

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