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
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. |
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. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
JANUMET Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
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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