GLYXAMBI

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, Hong Kong SAR China, Ireland, Israel, Lithuania, New Zealand, Poland, Singapore, Spain, Turkey, UK.

Active ingredients

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

1	Empagliflozin 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
2	Linagliptin UNII 3X29ZEJ4R2 - LINAGLIPTIN
	Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide). These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
	Read more about Linagliptin

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
GLYXAMBI 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
A10BD19	Linagliptin and empagliflozin	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 A10BD19

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	11269D, 11298P, 11303X, 11310G
BR	Câmara de Regulação do Mercado de Medicamentos	504519040021405, 504519040021505, 504519040021605, 504520070021307
CA	Health Products and Food Branch	02459752, 02459760
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	3106-MEE-1117, 3110-MEE-1117
EE	Ravimiamet	1733037, 1733048, 1733059, 1733060, 1733071, 1733082, 1733093, 1733105, 1733116, 1733127, 1733138, 1733149, 1733150, 1733161, 1733172, 1733183, 1733194, 1733206
ES	Centro de información online de medicamentos de la AEMPS	1161146005, 1161146014
FI	Lääkealan turvallisuus- ja kehittämiskeskus	121427, 178252, 535838, 577709
GB	Medicines & Healthcare Products Regulatory Agency	372253, 372256
HK	Department of Health Drug Office	65353, 65354
IE	Health Products Regulatory Authority	29213, 29214
IL	מִשְׂרַד הַבְּרִיאוּת	7820, 7821
LT	Valstybinė vaistų kontrolės tarnyba	1081725, 1081726, 1081727, 1081728, 1081729, 1081730, 1081731, 1081732, 1081733, 1081734, 1081735, 1081736, 1081737, 1081738, 1081739, 1081740, 1081741, 1081742
NZ	Medicines and Medical Devices Safety Authority	18086, 18087
PL	Rejestru Produktów Leczniczych	100381766, 100381772
SG	Health Sciences Authority	15272P, 15273P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699693090133, 8699693090140
US	FDA, National Drug Code	0597-0164, 0597-0182, 70518-2046