XIGDUO

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, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

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 more 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 more about Metformin

Medication package inserts

Below package inserts are available for further reading:

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