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

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - pravastatin sodium 10mg;   - tablet - 10 mg - active: pravastatin sodium 10mg   excipient: croscarmellose sodium iron oxide yellow lactose monohydrate light magnesium oxide magnesium stearate microcelac 100 povidone - pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and ldl-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · coronary artery disease: in patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, chd death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · cerebrovascular disease: in patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (tias). · cardiac and renal transplantation: in patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - pravastatin sodium 20mg;   - tablet - 20 mg - active: pravastatin sodium 20mg   excipient: croscarmellose sodium iron oxide yellow lactose monohydrate light magnesium oxide magnesium stearate microcelac 100 povidone - pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and ldl-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · coronary artery disease: in patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, chd death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · cerebrovascular disease: in patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (tias). · cardiac and renal transplantation: in patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - pravastatin sodium 40mg;   - tablet - 40 mg - active: pravastatin sodium 40mg   excipient: croscarmellose sodium iron oxide yellow lactose monohydrate light magnesium oxide magnesium stearate microcelac 100 povidone - pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and ldl-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · coronary artery disease: in patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, chd death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · cerebrovascular disease: in patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (tias). · cardiac and renal transplantation: in patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients

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

arrotex pharmaceuticals pty ltd - pravastatin sodium, quantity: 80 mg - tablet, uncoated - excipient ingredients: povidone; croscarmellose sodium; iron oxide yellow; microcrystalline cellulose; magnesium stearate; lactose monohydrate; magnesium oxide - as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/l) serum cholesterol levels. apx-pravastatin is indicated in patients with unstable angina pectoris (see clinical trials). apx-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 trails).

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

arrotex pharmaceuticals pty ltd - pravastatin sodium, quantity: 40 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; magnesium oxide; magnesium stearate; povidone; lactose monohydrate; iron oxide yellow; microcrystalline cellulose - 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, dysprotenemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. indications as at 20 august 1996: as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia, (e.g. poorly controlled diabetes mellitus, hypothroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. indications as at 2 march 1999: as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see clinical trials). indications as at 4 august 1999: as an adjunct to diet for the treatment of hypercholesterolaemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see clinical trials). apx-pravastatin is indicated in patients with unstable angina pectoris (see clinical trials). indications as at 23 january 2004: as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/l) serum cholesterol levels. apx-pravastatin is indicated in patients with unstable angina pectoris (see clinical trials). apx-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 trails).

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

arrotex pharmaceuticals pty ltd - pravastatin sodium, quantity: 20 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; magnesium stearate; povidone; microcrystalline cellulose; lactose monohydrate; iron oxide yellow; magnesium oxide - as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see clinical trials). indications as at 23 january 2004: as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/l) serum cholesterol levels. apx-pravastatin is indicated in patients with unstable angina pectoris (see clinical trials). apx-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 trails).

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

arrotex pharmaceuticals pty ltd - pravastatin sodium, quantity: 10 mg - tablet, uncoated - excipient ingredients: magnesium stearate; iron oxide yellow; magnesium oxide; croscarmellose sodium; microcrystalline cellulose; povidone; lactose monohydrate - as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction and average (normal) serum cholesterol levels (see clinical trials). indications as at 23 january 2004: as an adjunct to diet for the treatment of hypercholesterolemia. prior to initiating therapy with pravastatin, secondary causes of hypercholesterolemia (e.g. poorly controlled diabetes mellitus, hypothyrodism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alchoholism) should be identified and treated. apx-pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 - 5.5 mmol/l) serum cholesterol levels. apx-pravastatin is indicated in patients with unstable angina pectoris (see clinical trials). apx-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 trails).

Malta - English - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - pravastatin sodium - tablet - pravastatin sodium 10 mg - lipid modifying agents