SYNJARDY

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Cyprus, Estonia, Finland, France, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Spain, Turkey, UK.

Active ingredients

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

1	Empagliflozin UNII HDC1R2M35U - EMPAGLIFLOZIN
	Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2). Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption.
	Read more about Empagliflozin
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
SYNJARDY 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
A10BD20	Metformin and empagliflozin	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 → A10BD19 Linagliptin and empagliflozin
Discover more medicines within A10BD20

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02456575, 02456583, 02456591, 02456605, 02456613, 02456621
EE	Ravimiamet	1686821, 1686832, 1686843, 1686854, 1686865, 1686876, 1686887, 1686898, 1686900, 1686911, 1686922, 1686933, 1686944, 1686955, 1686966, 1686977, 1686988, 1686999, 1687002, 1687013, 1687024, 1687035, 1687046, 1687057, 1687068, 1687079, 1687080, 1687091, 1687103, 1687114, 1687125, 1687136, 1687147, 1687158, 1687169, 1687170, 1717602, 1717613, 1717624, 1717635
ES	Centro de información online de medicamentos de la AEMPS	1151003014, 1151003032
FI	Lääkealan turvallisuus- ja kehittämiskeskus	033614, 057347, 468130, 481968, 515341, 531573, 574615, 599973
FR	Base de données publique des médicaments	60901946, 64866745
GB	Medicines & Healthcare Products Regulatory Agency	301736, 301742, 301752, 301759, 378530, 378533
IE	Health Products Regulatory Authority	32647, 32648, 32649, 32650
IT	Agenzia del Farmaco	044229019, 044229021, 044229033, 044229045, 044229058, 044229060, 044229072, 044229084, 044229096, 044229108, 044229110, 044229122, 044229134, 044229146, 044229159, 044229161, 044229173, 044229185, 044229197, 044229209, 044229211, 044229223, 044229235, 044229247, 044229250, 044229262, 044229274, 044229286, 044229298, 044229300, 044229312, 044229324, 044229336, 044229348, 044229351, 044229363, 044229375, 044229387, 044229399, 044229401
LT	Valstybinė vaistų kontrolės tarnyba	1076777, 1076778, 1076779, 1076780, 1076781, 1076782, 1076783, 1076784, 1076785, 1076786, 1076787, 1076788, 1076789, 1076790, 1076791, 1076792, 1076793, 1076794, 1076795, 1076796, 1076797, 1076798, 1076799, 1076800, 1076801, 1076802, 1076803, 1076804, 1076805, 1076806, 1076807, 1076808, 1076809, 1076810, 1076811, 1076812, 1080859, 1080860, 1080861, 1080862
NL	Z-Index G-Standaard, PRK	128317, 128325
PL	Rejestru Produktów Leczniczych	100348993, 100349082, 100349136, 100349165
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64834001, W64834002, W64834003, W64834004, W64834005, W64834006, W64834007, W64834008, W64834009, W64834010, W64835001, W64835002, W64835003, W64835004, W64835005, W64835006, W64835007, W64835008, W64835009, W64835010, W64836001, W64836002, W64836003, W64836004, W64836005, W64836006, W64836007, W64836008, W64836009, W64836010, W64837001, W64837002, W64837003, W64837004, W64837005, W64837006, W64837007, W64837008, W64837009, W64837010
TR	İlaç ve Tıbbi Cihaz Kurumu	8699693090157, 8699693090164, 8699693090171, 8699693090188
US	FDA, National Drug Code	0597-0159, 0597-0168, 0597-0175, 0597-0180, 0597-0280, 0597-0290, 0597-0295, 0597-0300