Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - saxagliptin hydrochloride 5,578 mg - eq. saxagliptin 5 mg - film-coated tablet - 5 mg - saxagliptin hydrochloride 5.578 mg - saxagliptin

European Union - English - 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.)

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.

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - film-coated tablet - saxagliptin 2.5 mg - drugs used in diabetes

Malta - English - Medicines Authority

pharos – pharmaceutical oriented services limited lesvou str. (end), thesi loggos, industrial zone, 144 52 metamorfossi attikis,, greece - film-coated tablet - saxagliptin 5 mg - drugs used in diabetes

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 2.5mg - film coated tablet - 2.5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 2.5mg excipient: hydrochloric acid magnesium stearate opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 povidone purified water - kombiglyze is indicated as an adjunct to diet & exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin & metformin is appropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 500mg;  ; saxagliptin 2.5mg - film coated tablet - 2.5mg/500mg - active: metformin hydrochloride 500mg   saxagliptin 2.5mg excipient: hydrochloric acid magnesium stearate opacode blue s-1-10619 opadry pink 85f14452 opadry white 85f18422 povidone purified water - kombiglyze is indicated as an adjunct to diet & exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin & metformin is appropriate.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 850mg;  ; saxagliptin 2.5mg - film coated tablet - 2.5mg/850mg - active: metformin hydrochloride 850mg   saxagliptin 2.5mg excipient: hydrochloric acid magnesium stearate opacode blue s-1-10619 opadry butterscotch 85f17417 opadry white 85f18422 povidone purified water - kombiglyze is indicated as an adjunct to diet & exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin & metformin is appropriate.

Canada - English - Health Canada

sandoz canada incorporated - saxagliptin (saxagliptin hydrochloride) - tablet - 2.5mg - saxagliptin (saxagliptin hydrochloride) 2.5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors

Canada - English - Health Canada

sandoz canada incorporated - saxagliptin (saxagliptin hydrochloride) - tablet - 5mg - saxagliptin (saxagliptin hydrochloride) 5mg - dipeptidyl peptidase-4 (dpp-4) inhibitors