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

amneal pharma australia pty ltd - pravastatin sodium, quantity: 20 mg - tablet, uncoated - excipient ingredients: magnesium stearate; croscarmellose sodium; iron oxide yellow; lactose monohydrate; heavy magnesium oxide; microcrystalline cellulose; povidone - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, 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 is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/l) serum cholesterol levels.,3. pravastatin is indicated in patients with unstable angina pectoris (see clinical trials).,4. pravastatin 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)

amneal pharma australia pty ltd - pravastatin sodium, quantity: 10 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; heavy magnesium oxide; microcrystalline cellulose; croscarmellose sodium; iron oxide yellow; povidone; magnesium stearate - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, 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 is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/l) serum cholesterol levels.,3. pravastatin is indicated in patients with unstable angina pectoris (see clinical trials).,4. pravastatin 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)

amneal pharma australia pty ltd - pravastatin sodium, quantity: 40 mg - tablet, uncoated - excipient ingredients: magnesium stearate; povidone; iron oxide yellow; microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; heavy magnesium oxide - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, 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 is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/l) serum cholesterol levels.,3. pravastatin is indicated in patients with unstable angina pectoris (see clinical trials).,4. pravastatin 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)

amneal pharma australia pty ltd - pravastatin sodium, quantity: 80 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; povidone; microcrystalline cellulose; iron oxide yellow; lactose monohydrate; heavy magnesium oxide; magnesium stearate - 1. as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, 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 is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/l) serum cholesterol levels.,3. pravastatin is indicated in patients with unstable angina pectoris (see clinical trials).,4. pravastatin 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: 80 mg - tablet, film coated - excipient ingredients: crospovidone; sodium bicarbonate; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; titanium dioxide; macrogol 8000; hypromellose; iron oxide yellow; purified talc - 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; macrogol 8000; hypromellose; iron oxide yellow; purified talc - 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; macrogol 8000; hypromellose; iron oxide yellow; purified talc - 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; macrogol 8000; hypromellose; iron oxide yellow; purified talc - 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).

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).

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

generic health pty ltd - pravastatin sodium, quantity: 80 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 generichealth, 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 generichealth is indicated in patients with previous myocardial infarction including those who have normal (4.0-5.5 mmol/l) serum cholesterol levels. 3. pravastatin generichealth is indicated in patients with unstable angina pectoris (see clinical trials). 4. pravastatin generichealth 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).