Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - saxagliptin hydrochloride - tablet - 2.5mg

Cingapura - inglês - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - metformin hydrochloride + 0.5% magnesium stearate; saxagliptin hydrochloride anhydrous 2.79mg eqv saxagliptin - tablet, film coated, extended release - 1000.0 mg - metformin hydrochloride + 0.5% magnesium stearate 1000.0 mg; saxagliptin hydrochloride anhydrous 2.79mg eqv saxagliptin 2.5mg

Cingapura - inglês - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - metformin hydrochloride + 0.5% magnesium stearate; saxagliptin hydrochloride anhydrous 5.58mg eqv saxagliptin - tablet, film coated, extended release - 1000mg - metformin hydrochloride + 0.5% magnesium stearate 1000mg; saxagliptin hydrochloride anhydrous 5.58mg eqv saxagliptin 5.0mg

Cingapura - inglês - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - metformin hydrochloride + 0.5% magnesium stearate; saxagliptin hydrochloride anhydrous 5.58mg eqv saxagliptin - tablet, film coated, extended release - 500mg - metformin hydrochloride + 0.5% magnesium stearate 500mg; saxagliptin hydrochloride anhydrous 5.58mg eqv saxagliptin 5.0mg

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - saxagliptin hydrochloride -

Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - saxagliptin hydrochloride -

União Europeia - inglês - 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.

Israel - inglês - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 5 mg - saxagliptin - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Israel - inglês - Ministry of Health

astrazeneca (israel) ltd - saxagliptin as hydrochloride - film coated tablets - saxagliptin as hydrochloride 2.5 mg - saxagliptin - saxagliptin - monotherapy: onglyza is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.onglyza should not be used in patients with esrdcombination therapy: add-on combination: onglyza is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin, a thiazolidinedione (tzd), or a sulfonylurea (su), when the single agent alone, with diet and exercise, does not provide adequate glycemic control.initial combination: onglyza is indicated for use as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes mellitus when dual saxagliptin and metformin therapy is appropriate.onglyza should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.