Singapore - engelsk - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - dapagliflozin propanediol 12.30mg eqv dapagliflozin - tablet, film coated - 10mg - dapagliflozin propanediol 12.30mg eqv dapagliflozin 10mg

Singapore - engelsk - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - dapagliflozin propanediol 6.15mg eqv dapagliflozin - tablet, film coated - 5mg - dapagliflozin propanediol 6.15mg eqv dapagliflozin 5mg

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

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

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 1000mg;  ; saxagliptin 5mg (as saxagliptin hydrochloride) - modified release tablet - 5mg/1000mg - active: metformin hydrochloride 1000mg   saxagliptin 5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid hypromellose magnesium stearate opacode blue s-1-10619 opadry pink 85f14452 opadry white 85f18422 purified water     - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

astrazeneca limited - metformin hydrochloride 500mg;  ; saxagliptin 5mg (as saxagliptin hydrochloride) - modified release tablet - 5mg/500mg - active: metformin hydrochloride 500mg   saxagliptin 5mg (as saxagliptin hydrochloride) excipient: carmellose sodium hydrochloric acid   hypromellose magnesium stearate microcrystalline cellulose opacode blue s-1-10619 opadry butterscotch 85f17417 opadry white 85f18422 purified water     - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

Den Europæiske Union - engelsk - 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.

Jordan - engelsk - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة أدوية الحكمة - hikma pharmaceuticals - metformin hcl 1000 mg/tab, dapagliflozin propanediol monohydrate 10 mg/tab - 1000 mg/tab, monohydrate 10 mg/tab

Den Europæiske Union - engelsk - 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.

Den Europæiske Union - engelsk - 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.)

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

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