JANUMET

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

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 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 about Metformin

Medication package inserts

Below package inserts are available for further reading:

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

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