XULTOPHY

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

Active ingredients

The drug XULTOPHY contains a combination of these active pharmaceutical ingredients (APIs):

1 Insulin degludec UNII 54Q18076QB - INSULIN DEGLUDEC

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. Read about Insulin degludec

2 Liraglutide UNII 839I73S42A - LIRAGLUTIDE

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. Read about Liraglutide

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XULTOPHY Solution for injection	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
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
Discover more medicines within A10AE56

Authorization and marketing

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: IT	Agenzia del Farmaco	Identifier(s): 043619016, 043619028, 043619030, 043619042
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