KOMBIGLYZE XR

This brand name is authorized in United States. It is also authorized in Australia, Brazil, Ecuador, Hong Kong SAR China, Mexico, New Zealand, Singapore, Tunisia.

Active ingredients

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

1	Saxagliptin UNII Z8J84YIX6L - SAXAGLIPTIN HYDROCHLORIDE
	Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor. Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
	Read more about Saxagliptin
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
KOMBIGLYZE XR Film-coated tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
A10BD10	Metformin and saxagliptin	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 A10BD10

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	10048W, 10051B, 10055F, 11285Y, 11299Q, 11312J
BR	Câmara de Regulação do Mercado de Medicamentos	502317120032717, 502317120032817, 502317120032917, 502317120033017, 502317120033117
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H6510913, H6520913, H6530913
HK	Department of Health Drug Office	62251, 62252, 62253
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	138M2012
NZ	Medicines and Medical Devices Safety Authority	16847, 16848, 16849
SG	Health Sciences Authority	14112P, 14113P, 14114P
TN	Direction de la Pharmacie et du Médicament	8233021, 8233022
US	FDA, National Drug Code	0310-6125, 0310-6135, 0310-6145