This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa
The drug XULTOPHY contains a combination of these active pharmaceutical ingredients (APIs):
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1
Insulin degludec
UNII 54Q18076QB - INSULIN DEGLUDEC
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Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver. |
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2
Liraglutide
UNII 839I73S42A - LIRAGLUTIDE
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Liraglutide is a GLP-1 analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor. The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from the pancreatic beta cells. Unlike native GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once daily administration. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| XULTOPHY Solution for injection | 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 |
|---|---|---|
| A10AE56 | Insulin degludec and liraglutide | A Alimentary tract and metabolism → A10 Drugs used in diabetes → A10A Insulins and analogues → A10AE Insulins and analogues for injection, long-acting |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 526618010008705, 526618010008805, 526618010008905 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02474875 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 221-MBE-1221 |
| Country: EE | Ravimiamet | Identifier(s): 1665075, 1665086, 1665097, 1665109 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60480810 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 304586 |
| Country: HK | Department of Health Drug Office | Identifier(s): 65897 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 29225 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 7886 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 3969500G1029 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1074498, 1074499, 1074500, 1074501 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 135496 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100327330 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W66240001, W66240002, W66240003, W66240004 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699676950188, 8699676950195, 8699676950201, 8699676950218 |
| Country: US | FDA, National Drug Code | Identifier(s): 0169-2911 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 50/21.13/0985 |
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