JANUVIA

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, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

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

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
JANUVIA 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
A10BH01	Sitagliptin	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 A10BH01

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	11572C, 11573D, 11576G, 9180E, 9181F, 9182G
BR	Câmara de Regulação do Mercado de Medicamentos	525503701111217, 525503702118215, 525503703114213, 525503704110211, 525521090021603, 525521090021703, 525521090021803, 525521090021903
CA	Health Products and Food Branch	02303922, 02388839, 02388847
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1285-MEE-0815, 27.518-02-07
EE	Ravimiamet	1286434, 1286445, 1286456, 1286467, 1286478, 1286489, 1286490, 1286502, 1286513, 1286524, 1286535, 1286546, 1286557, 1286568, 1286579, 1286580, 1286591, 1286603, 1665918, 1665929, 1665930, 1665941, 1665952, 1665963
ES	Centro de información online de medicamentos de la AEMPS	07383002, 07383008, 07383014, 07383015
FI	Lääkealan turvallisuus- ja kehittämiskeskus	076006, 076015, 076024, 076033, 076043, 076052
FR	Base de données publique des médicaments	60595727, 64889982
GB	Medicines & Healthcare Products Regulatory Agency	114738, 175673, 180615, 185871, 201149, 201152, 368898, 368900, 374403, 374405, 374407, 376677, 376681, 376683, 379903, 381418, 381420
HK	Department of Health Drug Office	56092, 56093, 56094
IE	Health Products Regulatory Authority	13117, 15547, 15682, 19675, 23521, 23569, 29714, 29720, 48043, 48057
IL	מִשְׂרַד הַבְּרִיאוּת	6106, 6107, 6108
IT	Agenzia del Farmaco	037793015, 037793027, 037793039, 037793041, 037793054, 037793066, 037793078, 037793080, 037793092, 037793104, 037793116, 037793128, 037793130, 037793142, 037793155, 037793167, 037793179, 037793181, 037793193, 037793205, 037793217, 037793229, 037793231, 037793243
JP	医薬品医療機器総合機構	3969010F1034, 3969010F2030, 3969010F3037, 3969010F4033
LT	Valstybinė vaistų kontrolės tarnyba	1005482, 1029645, 1029646, 1029647, 1029648, 1029649, 1029650, 1029651, 1029652, 1029653, 1029654, 1029655, 1029656, 1029657, 1029659, 1029660, 1029661, 1029662, 1075272, 1075273, 1075274, 1075275, 1075276, 1075277
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	238M2006
NL	Z-Index G-Standaard, PRK	83593, 83887, 83895
PL	Rejestru Produktów Leczniczych	100152178, 100152480, 100325242
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64831001, W64831002, W64831003, W64831004, W64831005, W64831006, W64964001, W64964002, W64964003, W64964004, W64964005, W64964006
SG	Health Sciences Authority	13257P, 13258P, 13259P
TN	Direction de la Pharmacie et du Médicament	3443071
TR	İlaç ve Tıbbi Cihaz Kurumu	8699636090916, 8699636091524
US	FDA, National Drug Code	0006-0112, 0006-0221, 0006-0277, 50090-3472, 50090-3527, 50090-4084, 50090-4086, 55154-5040, 55154-5042
ZA	Health Products Regulatory Authority	41/21.2/0354, 41/21.2/0355, 41/21.2/0356