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.

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 - valsartan, quantity: 160 mg; hydrochlorothiazide, quantity: 12.5 mg; amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: crospovidone; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; 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).

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - amlodipine besilate, valsartan - hypertension - agents acting on the renin-angiotensin system - treatment of essential hypertension.amlodipine/valsartan mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.