Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); valsartan, quantity: 80 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; crospovidone; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide yellow - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); valsartan, quantity: 320 mg - tablet, film coated - excipient ingredients: crospovidone; colloidal anhydrous silica; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; iron oxide yellow; titanium dioxide; hypromellose; purified talc; macrogol 4000 - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); valsartan, quantity: 320 mg - tablet, film coated - excipient ingredients: crospovidone; sodium starch glycollate; iron oxide yellow; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hypromellose; purified talc; iron oxide red; macrogol 4000 - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); valsartan, quantity: 160 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide red; iron oxide yellow - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 160 mg; amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; colloidal anhydrous silica; hypromellose; purified talc; iron oxide yellow; macrogol 4000; titanium dioxide - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - vildagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone.in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets.in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 320 mg; hydrochlorothiazide, quantity: 25 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg) - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; crospovidone; microcrystalline cellulose; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); hydrochlorothiazide, quantity: 25 mg; valsartan, quantity: 160 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; crospovidone; microcrystalline cellulose; hypromellose; purified talc; iron oxide yellow; macrogol 4000 - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 160 mg; amlodipine besilate, quantity: 13.87 mg (equivalent: amlodipine, qty 10 mg); hydrochlorothiazide, quantity: 12.5 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; crospovidone; magnesium stearate; hypromellose; purified talc; iron oxide red; macrogol 4000; iron oxide yellow; titanium dioxide - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - hydrochlorothiazide, quantity: 25 mg; valsartan, quantity: 160 mg; amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; crospovidone; magnesium stearate; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide yellow - amlodipine/valsartan/hct novartis is indicated only as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single component formulations or as dual-component formulation with a single component formulation, all components at the same dose level. treatment should not be initiated with these fixed-dose combinations (see dosage and administration).