FORXIGA

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

Active ingredients

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

1 Dapagliflozin
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 about Dapagliflozin

Medication package inserts

Below package inserts are available for further reading:

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

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