XULTOPHY

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

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 more 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 more about Liraglutide

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
XULTOPHY Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	526618010008705, 526618010008805, 526618010008905
CA	Health Products and Food Branch	02474875
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	221-MBE-1221
EE	Ravimiamet	1665075, 1665086, 1665097, 1665109
FR	Base de données publique des médicaments	60480810
GB	Medicines & Healthcare Products Regulatory Agency	304586
HK	Department of Health Drug Office	65897
IE	Health Products Regulatory Authority	29225
IL	מִשְׂרַד הַבְּרִיאוּת	7886
IT	Agenzia del Farmaco	043619016, 043619028, 043619030, 043619042
JP	医薬品医療機器総合機構	3969500G1029
LT	Valstybinė vaistų kontrolės tarnyba	1074498, 1074499, 1074500, 1074501
NL	Z-Index G-Standaard, PRK	135496
PL	Rejestru Produktów Leczniczych	100327330
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W66240001, W66240002, W66240003, W66240004
TR	İlaç ve Tıbbi Cihaz Kurumu	8699676950188, 8699676950195, 8699676950201, 8699676950218
US	FDA, National Drug Code	0169-2911
ZA	Health Products Regulatory Authority	50/21.13/0985