Australië - Engels - 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).

Australië - Engels - 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).

Europese Unie - Engels - 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.

Verenigde Staten - Engels - NLM (National Library of Medicine)

remedyrepack inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - amlodipine, valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the arb class to which valsartan principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high

Europese Unie - Engels - EMA (European Medicines Agency)

novartis europharm limited - amlodipine, valsartan, hydrochlorothiazide - hypertension - angiotensin ii antagonists, combinations, agents acting on the renin-angiotensin system, angiotensin ii antagonists and calcium channel blockers - treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (hct), taken either as three single-component formulations or as a dual-component and a single-component formulation.

Ierland - Engels - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - valsartan; hydrochlorothiazide - film-coated tablet - 80/12.5 mg/mg - angiotensin ii antagonists and diuretics; valsartan and diuretics

Ierland - Engels - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - valsartan; hydrochlorothiazide - film-coated tablet - 160/25 mg/mg - angiotensin ii antagonists and diuretics; valsartan and diuretics

Ierland - Engels - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - valsartan; hydrochlorothiazide - film-coated tablet - 160/12.5 mg/mg - angiotensin ii antagonists and diuretics; valsartan and diuretics

Ierland - Engels - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - valsartan; hydrochlorothiazide - film-coated tablet - 80 mg/12.5 milligram(s) - angiotensin ii antagonists and diuretics; valsartan and diuretics

Ierland - Engels - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - valsartan; hydrochlorothiazide - film-coated tablet - 160 mg/25 milligram(s) - angiotensin ii antagonists and diuretics; valsartan and diuretics