GLYXAMBI

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

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 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 about Linagliptin

Medication package inserts

Below package inserts are available for further reading:

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