JANUVIA

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

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 about Sitagliptin

Medication package inserts

Below package inserts are available for further reading:

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