Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 850mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 850mg - biguanides

Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); metformin hydrochloride - tablet - 2.5mg; 1000mg - saxagliptin (saxagliptin hydrochloride) 2.5mg; metformin hydrochloride 1000mg - biguanides

Unione Europea - inglese - 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.

Unione Europea - inglese - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drugs used in diabetes - qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (su) and one of the monocomponents of qtern do not provide adequate glycaemic control,when already being treated with the free combination of dapagliflozin and saxagliptin.(see sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)

Malesia - inglese - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - metformin hydrochloride; saxagliptin hydrochloride -

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - metformin hydrochloride; saxagliptin hydrochloride - tablet - 850mg ; 2.5mg

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - metformin hydrochloride; saxagliptin hydrochloride - tablet - 1gram ; 2.5mg

Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); dapagliflozin (dapagliflozin propanediol monohydrate) - tablet - 5mg; 5mg - saxagliptin (saxagliptin hydrochloride) 5mg; dapagliflozin (dapagliflozin propanediol monohydrate) 5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Canada - inglese - Health Canada

astrazeneca canada inc - saxagliptin (saxagliptin hydrochloride); dapagliflozin (dapagliflozin propanediol monohydrate) - tablet - 5mg; 10mg - saxagliptin (saxagliptin hydrochloride) 5mg; dapagliflozin (dapagliflozin propanediol monohydrate) 10mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Stati Uniti - inglese - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - saxagliptin hydrochloride (unii: z8j84yix6l) (saxagliptin anhydrous - unii:8i7io46ivq) - saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14) ]. saxagliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. saxagliptin tablets are contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions [see warnings and precautions (5.4) and adverse reactions (6.2) ]. risk summary limited data with saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . no adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period