Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - pravastatin sodium - tablets - pravastatin sodium 10 mg - pravastatin - 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 c

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - pravastatin sodium - tablets - pravastatin sodium 20 mg - pravastatin - 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 co

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).

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - pravastatin sodium - tablets - 10 milligram - pravastatin

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - pravastatin sodium - tablets - 40 milligram - pravastatin

Israel - English - Ministry of Health

teva israel ltd - pravastatin sodium - tablets - pravastatin sodium 40 mg - hmg coa reductase inhibitors - 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).

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

lupin australia pty limited - pravastatin sodium, quantity: 80 mg - tablet, film coated - excipient ingredients: crospovidone; sodium bicarbonate; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

lupin australia pty limited - pravastatin sodium, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

lupin australia pty limited - pravastatin sodium, quantity: 20 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).

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

lupin australia pty limited - pravastatin sodium, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; crospovidone; sodium bicarbonate; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; purified talc; iron oxide yellow - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin-lupin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. 2. pravastatin-lupin is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin-lupin is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin-lupin is indicated as an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see clinical trials).