KOMBIGLYZE XR

This brand name is authorized in Australia, Brazil, Ecuador, Hong Kong, Mexico, New Zealand, Singapore, Tunisia, United States

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 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 about Metformin

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
KOMBIGLYZE XR Film-coated tablet FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

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

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

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