ONGLYZA

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

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 about Saxagliptin

Medication package inserts

Below package inserts are available for further reading:

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