Malta - English - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - pravastatin sodium - tablet - pravastatin sodium 20 mg - lipid modifying agents

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

apotex pty ltd - simvastatin -

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

medis pharma pty ltd - amlodipine besilate, quantity: 13.87 mg; atorvastatin calcium trihydrate, quantity: 21.7 mg - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000; indigo carmine aluminium lake - amlodipine/atorvastatin-zp (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

medis pharma pty ltd - amlodipine besilate, quantity: 6.94 mg; atorvastatin calcium trihydrate, quantity: 21.7 mg - tablet, film coated - excipient ingredients: calcium carbonate; colloidal anhydrous silica; hyprolose; magnesium stearate; pregelatinised maize starch; croscarmellose sodium; microcrystalline cellulose; polysorbate 80; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - amlodipine/atorvastatin-zp (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.,the indications for amlodipine are:,1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.,2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs,the indications for atorvastatin are:,1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.,prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.,2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.,these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Israel - English - Ministry of Health

teva israel ltd - pravastatin sodium - tablets - pravastatin sodium 20 mg - pravastatin - pravastatin is indicated as a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia . pravastatin should be used in addition to a diet restricted in saturated fat and cholesterol when the response to diet and other nonpharmacological measures alone has been inadequate. *primary prevention of coronary events: in hypercholesterolemic patients whthout clinically evident coronary heart disease pravastatin is indicated to: - reduce the risk of myocardial infarcton. - reduce the risk for revascularization. - reduce the risk of deaths due to cardiovascular causes with no increase in deaths from non-cardiovascular causes. *secondary prevention of cardiovascular events: atherosclerosis: in hypercholesterolemic patients with clinically evident coronary artery disease including prior mi pravastatin is indicated to: - slow the progression of coronary atherosclerosis. - reduce the risk of acute coronary events. myocardial infarction: in patients with previous myocardial infarction and normal cholesterol levels pravastatin is indicated to: - reduce the risk of recurrent myocardial infarction. - reduce the risk of undergoing myocardial revascularization procedures. - reduce the risk of stroke and transient ischemic attack (tia). *hypercholesterolemia and mixed dyslipidemia: pravastatin is indicated as an adjunct to diet to reduce elevated total-c ldl-c and tg levels in patients with primary hypercholesterolemia and mixed dyslipidemia (fredrickson type iia and iib).

Canada - English - Health Canada

qd pharmaceuticals ulc - simvastatin - tablet - 20mg - simvastatin 20mg - hmg-coa reductase inhibitors

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - simvastatin - film-coated tablet - 20 milligram(s) - hmg coa reductase inhibitors; simvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

genthon b.v. - simvastatin - film-coated tablet - 20 milligram(s) - hmg coa reductase inhibitors; simvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - simvastatin - film-coated tablet - 20 milligram(s) - hmg coa reductase inhibitors; simvastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - simvastatin - film-coated tablet - 20 milligram(s) - hmg coa reductase inhibitors; simvastatin