JANUMET

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

Active ingredients

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

1	Sitagliptin UNII TS63EW8X6F - SITAGLIPTIN PHOSPHATE
	Sitagliptin is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors. The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones.
	Read more about Sitagliptin
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
JANUMET 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
A10BD07	Metformin and sitagliptin	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 A10BD07

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	10089B, 10090C, 11566R, 11574E, 11580L, 11582N, 11586T, 9449H, 9450J, 9451K
BR	Câmara de Regulação do Mercado de Medicamentos	525504501116213, 525504503119211, 525504504115218, 525504505111216, 525504506118214, 525515030016805, 525515030017005, 525515030017105, 525515120019005, 525516050019805, 525518080020803
CA	Health Products and Food Branch	02333856, 02333864, 02333872, 02416786, 02416794, 02416808
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1754-MEE-0116, 1794-MEE-0216, 29431-11-10, 29432-11-10, 29495-11-10
EE	Ravimiamet	1360864, 1360954, 1360965, 1360976, 1360987, 1360998, 1361001, 1361012, 1361023, 1361034, 1361045, 1361056, 1361067, 1361078, 1650642, 1650653, 1650664, 1650675
ES	Centro de información online de medicamentos de la AEMPS	08455010, 08455010IP, 08455010IP1, 08455010IP2, 08455010IP3
FI	Lääkealan turvallisuus- ja kehittämiskeskus	028110, 028121, 143609, 143631
FR	Base de données publique des médicaments	66010671
GB	Medicines & Healthcare Products Regulatory Agency	170606, 374401, 376674, 379901, 381416
HK	Department of Health Drug Office	56186, 56187, 63246, 63249, 63250, 64857, 64858
IE	Health Products Regulatory Authority	19035, 29705, 29710, 29751, 29765, 29766, 29768, 29770
IT	Agenzia del Farmaco	038672010, 038672022, 038672034, 038672046, 038672059, 038672061, 038672073, 038672085, 038672097, 038672109, 038672111, 038672123, 038672135, 038672147, 038672174, 038672186, 038672198, 038672200, 038672212, 038672224
LT	Valstybinė vaistų kontrolės tarnyba	1033456, 1033457, 1033458, 1033459, 1033460, 1033461, 1033462, 1033463, 1033464, 1033465, 1033466, 1033467, 1033468, 1033469, 1056582, 1056583, 1074077, 1074078, 1074079, 1074080, 1074081, 1074082
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	134M2007, 157M2014
NL	Z-Index G-Standaard, PRK	87025, 87033
PL	Rejestru Produktów Leczniczych	100265095, 100265103
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64669001, W64669002, W64669003, W64669004, W64669005, W64669006, W64669007, W64669008
SG	Health Sciences Authority	13442P, 13443P, 13444P, 14702P, 14703P, 14704P
TN	Direction de la Pharmacie et du Médicament	3443092, 70133141
TR	İlaç ve Tıbbi Cihaz Kurumu	8699636090923, 8699636090930, 8699636090947
US	FDA, National Drug Code	0006-0078, 0006-0080, 0006-0081, 0006-0575, 0006-0577, 70518-2548
ZA	Health Products Regulatory Authority	42/21.2/1089, 42/21.2/1090, 42/21.2/1091