ONGLYZA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug ONGLYZA contains one active pharmaceutical ingredient (API):

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

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ONGLYZA 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
A10BH03	Saxagliptin	A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10B Blood glucose lowering drugs, excl. insulins → A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors
Discover more medicines within A10BH03

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	10128C, 11292H, 11311H, 8983T
BR	Câmara de Regulação do Mercado de Medicamentos	502317100031217, 502317100031317, 502317100031417, 505108003119316
CA	Health Products and Food Branch	02333554, 02375842
EE	Ravimiamet	1456174, 1456185, 1456196, 1456208, 1456219, 1456220, 1518814, 1518825, 1518836, 1518858, 1518869
ES	Centro de información online de medicamentos de la AEMPS	09545006, 09545012
FI	Lääkealan turvallisuus- ja kehittämiskeskus	063056, 063067, 112908, 570014
FR	Base de données publique des médicaments	66862731
GB	Medicines & Healthcare Products Regulatory Agency	159931, 179002, 185964, 375273, 375275, 376965, 379928, 379930, 381579, 381581
HK	Department of Health Drug Office	59907, 60783
IE	Health Products Regulatory Authority	37526, 37535, 42941
IL	מִשְׂרַד הַבְּרִיאוּת	6579
IT	Agenzia del Farmaco	039453016, 039453028, 039453030, 039453042, 039453055, 039453067, 039453079, 039453081, 039453093, 039453105, 039453117, 039453129, 039453131, 039453143, 039453156
JP	医薬品医療機器総合機構	3969017F1028, 3969017F2024
LT	Valstybinė vaistų kontrolės tarnyba	1051065, 1051066, 1051067, 1051068, 1051069, 1051070, 1051071, 1051072, 1051073, 1051074, 1059630, 1059631, 1059632, 1059633, 1059634
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	221M2009
NL	Z-Index G-Standaard, PRK	91812, 96938
NZ	Medicines and Medical Devices Safety Authority	14218, 15144
PL	Rejestru Produktów Leczniczych	100215743, 100242020
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W62289001, W62289002, W62289003, W62289004, W62289005, W62289006, W62289007, W62289008, W62289009, W62289010
SG	Health Sciences Authority	13891P, 13892P
TN	Direction de la Pharmacie et du Médicament	8233031
TR	İlaç ve Tıbbi Cihaz Kurumu	8699786090569
US	FDA, National Drug Code	0310-6100, 0310-6105, 55154-6931
ZA	Health Products Regulatory Authority	43/21.2/0609