European Union - English - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure.chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drugs used in diabetes - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure.chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

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

astrazeneca uk ltd - dapagliflozin propanediol monohydrate - tablet - 5mg

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

astrazeneca uk ltd - dapagliflozin propanediol monohydrate - tablet - 10mg

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

astrazeneca uk ltd - dapagliflozin propanediol monohydrate; saxagliptin hydrochloride - tablet - 10mg ; 5mg

Malta - English - Medicines Authority

cipla europe n.v. uitbreidingstraat 80, 2600 antwerp, belgium - film-coated tablet - dapagliflozin 10 mg - drugs used in diabetes

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.)

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 12.30 mg/dose - dapagliflozin - forxiga is indicated:- in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •as monotherapy when metformin is considered inappropriate due to intolerance. •in addition to other medicinal products for the treatment of type 2 diabetes. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (nyha class ii-iv) with reduced ejection fraction- to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. limitations of use -forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. forxiga is not expected to be effective in these populations.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 6.150 mg/dose - dapagliflozin - forxiga is indicated:- in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise •as monotherapy when metformin is considered inappropriate due to intolerance. •in addition to other medicinal products for the treatment of type 2 diabetes. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (nyha class ii-iv) with reduced ejection fraction- to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. limitations of use -forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. forxiga is not expected to be effective in these populations.

Kenya - English - Pharmacy and Poisons Board

dawa limited plot no 7879/8,baba dogo road,ruaraka-p.o box - dapagliflozin propanediol monohydrate - film-coated tablet - each film coated tablet contains: dapagliflozin… - dapagliflozin