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

astrazeneca sdn. bhd. - saxagliptin hydrochloride; dapagliflozin propanediol -

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, type 2 - drugs used in diabetes - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 5 mg - saxagliptin - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 2.5 mg - saxagliptin - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, saxagliptin, dapagliflozin - diabetes mellitus, type 2 - drugs used in diabetes - qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin with or without sulphonylurea (su) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control.when already being treated with metformin and saxagliptin and dapagliflozin.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab  - metformin hydrochloride, saxagliptin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.

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

astrazeneca pharmaceuticals lp - dapagliflozin (unii: 1ull0qj8uc) (dapagliflozin - unii:1ull0qj8uc), saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - qternmet xr (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use qternmet xr is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. qternmet xr initiation is intended only for patients currently taking metformin. qternmet xr is contraindicated in patients with: risk summary based on animal data showing adverse renal effects, from dapagliflozin, qternmet xr is not recommended during the second and third trimesters of pregnancy. the limited available data with qternmet xr or components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see data ). there are risks to the moth

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

astrazeneca pharmaceuticals lp - dapagliflozin (unii: 1ull0qj8uc) (dapagliflozin - unii:1ull0qj8uc), saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq) - dapagliflozin 10 mg - qtern is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use qtern is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1) ] . qtern is contraindicated in patients with: risk summary based on animal data showing adverse renal effects from dapagliflozin, qtern is not recommended during the second and third trimesters of pregnancy. the limited available data with qtern or its components (dapagliflozin and saxagliptin) in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal pelvic and tubular dilatations, that were not fully reversible, were observed in rats when dapagliflozin (a component of qtern) was administered during a period of renal

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

astrazeneca uk ltd - saxagliptin hydrochloride - tablet - 5mg

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

astrazeneca uk ltd - saxagliptin hydrochloride - tablet - 2.5mg