KOMBOGLYZE

This brand name is authorized in Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Poland, Romania, United Kingdom

Active ingredients

The drug KOMBOGLYZE 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  
KOMBOGLYZE 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
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: CA Health Products and Food Branch Identifier(s): 02389169, 02389177, 02389185
Country: EE Ravimiamet Identifier(s): 1550258, 1550269, 1550270, 1550281, 1550292, 1550304, 1550315, 1550326, 1550337, 1550348, 1595392, 1595415
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 11731002, 11731008
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 041281, 112566, 134199
Country: FR Base de données publique des médicaments Identifier(s): 68674913
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 217054, 217057, 381441
Country: IE Health Products Regulatory Authority Identifier(s): 16739, 16768
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1064103, 1064104, 1064105, 1064106, 1064107, 1064108, 1064109, 1064110, 1064111, 1064112, 1064113, 1064114, 1067965, 1067966
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100261594, 100261602
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W62421001, W62421002, W62421003, W62421004, W62421005, W62421006, W62421007

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