United States - English - NLM (National Library of Medicine)

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb), liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - insulin degludec 100 [iu] in 1 ml - xultophy 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use: xultophy 100/3.6 is contraindicated: risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. xultophy 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no available data with xultophy 100/3.6, insulin degludec or liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see clinical considerations]. for insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 u/kg/day. no adverse outcomes were observed for pregnant ani

Israel - English - Ministry of Health

novo nordisk ltd., israel - insulin degludec; liraglutide - solution for injection - insulin degludec 100 u/ml; liraglutide 3.6 mg/ml - insulin degludec and liraglutide - xultophy® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control, and the population studied, see sections 4.4, 4.5 and 5.1

European Union - English - EMA (European Medicines Agency)

novo nordisk a/s - insulin degludec, liraglutide - diabetes mellitus, type 2 - drugs used in diabetes - xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a glp-1 receptor agonist or basal insulin do not provide adequate glycaemic control.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - liraglutide; insulin degludec -

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin degludec, quantity: 100 u/ml; liraglutide, quantity: 3.6 u/ml - solution - excipient ingredients: phenol; zinc; glycerol; water for injections; sodium hydroxide; hydrochloric acid - xultophy is indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, with or without other oral glucose-lowering medicinal products (see section 5.1 pharmacodynamic properties-clinical trials and section 4.4 special warnings and precautions for use? for available data on the different combinations).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

novo nordisk ltd - insulin degludec; liraglutide - solution for injection - 100unit/1ml ; 3.6mg/1ml

Canada - English - Health Canada

novo nordisk canada inc - insulin degludec; liraglutide - solution - 100unit; 3.6mg - insulin degludec 100unit; liraglutide 3.6mg - insulins

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: novo nordisk pharmaceuticals (philippines), inc.; distributor: novo nordisk pharmaceuticals (philippines), inc. - insulin degludec , liraglutide - solution for injection (sc) - 100 u/3.6 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

novo nordisk, denmark - insulin degludec,liraglutide - solution for injection - 100,3.6 mg/ml, u/m

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

novo nordisk (pty) ltd û (rivonia) - injection - see ingredients - each 1,0 ml solution contains insulin degludec 100,0 iu liraglutide 3,6 mg