United States - English - NLM (National Library of Medicine)

rising health, llc - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 10 mg - pravastatin sodium tablets are indicated: - to reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (ldl-c) without clinically evident coronary heart disease (chd). - to reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident chd. - as an adjunct to diet to reduce ldl-c in adults with primary hyperlipidemia. - as an adjunct to diet to reduce ldl-c in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. hypertriglyceridemia. - primary dysbetalipoproteinemia. - hypertriglyceridemia. - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3) ]. - hypersensitivity to a

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 10 mg - pravastatin sodium tablets are indicated: - to reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (ldl-c) without clinically evident coronary heart disease (chd). - to reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident chd. - as an adjunct to diet to reduce ldl-c in adults with primary hyperlipidemia. - as an adjunct to diet to reduce ldl-c in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia. hypertriglyceridemia. - primary dysbetalipoproteinemia. - hypertriglyceridemia. - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3) ]. - hypersensitivity to a

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 20 mg - pravastatin sodium tablet is indicated: - to reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (ldl-c) without clinically evident coronary heart disease (chd). - to reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident chd. - as an adjunct to diet to reduce ldl-c in adults with primary hyperlipidemia. - as an adjunct to diet to reduce ldl-c in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (hefh). - as an adjunct to diet for the treatment of adults with: primary dysbetalipoproteinemia hypertriglyceridemia - primary dysbetalipoproteinemia - hypertriglyceridemia - acute liver failure or decompensated cirrhosis

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).

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).

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

dr reddys laboratories australia pty ltd - pravastatin sodium, quantity: 80 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; meglumine; crospovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 8000; purified talc - 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. pravastatin-drla is indicated in patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. pravastatin-drla is indicated in patients with unstable angina pectoris (see clinical trials). pravastatin-drla 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)

dr reddys laboratories australia pty ltd - pravastatin sodium, quantity: 40 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; meglumine; crospovidone; magnesium stearate; croscarmellose sodium; titanium dioxide; hypromellose; macrogol 8000; purified talc - 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. pravastatin-drla is indicated in patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/l) serum cholesterol levels. pravastatin-drla is indicated in patients with unstable angina pectoris (see clinical trials). pravastatin-drla 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).