Canada - English - 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 - English - 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

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

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

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 as propanediol; saxagliptin as hydrochloride monohydrate - film coated tablets - dapagliflozin as propanediol 10 mg; saxagliptin as hydrochloride monohydrate 5 mg - saxagliptin and dapagliflozin - 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.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin as propanediol; saxagliptin as hydrochloride monohydrate - film coated tablets - dapagliflozin as propanediol 10 mg; saxagliptin as hydrochloride monohydrate 5 mg - saxagliptin and dapagliflozin - 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.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin as propanediol; saxagliptin as hydrochloride monohydrate - film coated tablets - dapagliflozin as propanediol 10 mg; saxagliptin as hydrochloride monohydrate 5 mg - saxagliptin and dapagliflozin - 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.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin as propanediol; saxagliptin as hydrochloride monohydrate - film coated tablets - dapagliflozin as propanediol 10 mg; saxagliptin as hydrochloride monohydrate 5 mg - saxagliptin and dapagliflozin - 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.

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

شركة أدوية الحكمة - hikma pharmaceuticals - saxagliptin 5 mg/1 tab , dapagliflozin 10 mg/1 tab - 5 mg/1 tab , 10 mg/1 tab

Kenya - English - Pharmacy and Poisons Board

zawadi healthcare ltd p.o.box 14629 - 00800, maua close,westlands, - dapagliflozin - tablet - 10 mg - saxagliptin and dapagliflozin