XIGDUO

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

Active ingredients

The drug XIGDUO contains a combination of these active pharmaceutical ingredients (APIs):

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

2 Metformin UNII 786Z46389E - METFORMIN HYDROCHLORIDE

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. Read about Metformin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XIGDUO 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
A10BD15	Metformin and dapagliflozin	A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10B Blood glucose lowering drugs, excl. insulins → A10BD Combinations of oral blood glucose lowering drugs
Discover more medicines within A10BD15

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): 10510E, 10515K, 10516L, 11270E, 11300R, 11313K
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502317110032217, 502317110032317, 502317110032417, 502317110032517, 502317110032617, 505116010022505
Country: CA	Health Products and Food Branch	Identifier(s): 02449935, 02449943
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 1995-MEE-0416, 2348-MEE-0716
Country: EE	Ravimiamet	Identifier(s): 1637849, 1637850, 1637861, 1637872, 1637883, 1637894, 1637906, 1637917, 1637928, 1637939
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 113900003, 113900009
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 052071, 054950, 379097, 393404
Country: FR	Base de données publique des médicaments	Identifier(s): 60267506
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 240182, 240186, 375386, 381765
Country: HK	Department of Health Drug Office	Identifier(s): 65367, 65368, 65369
Country: IE	Health Products Regulatory Authority	Identifier(s): 36850, 36851
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7934, 7935
Country: IT	Agenzia del Farmaco	Identifier(s): 043208014, 043208026, 043208038, 043208040, 043208053, 043208065, 043208077, 043208089, 043208091, 043208103, 043208115, 043208127
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1072633, 1072634, 1072635, 1072636, 1072637, 1072638, 1072639, 1072640, 1072641, 1072642, 1072643, 1072644
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 115525, 115533
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17400, 17401, 17403
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100139367, 100310312
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W62325003, W62325004
Country: SG	Health Sciences Authority	Identifier(s): 15077P, 15078P, 15079P, 15080P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699786092808, 8699786092815
Country: US	FDA, National Drug Code	Identifier(s): 0310-6225, 0310-6250, 0310-6260, 0310-6270, 0310-6280