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

sanofi-aventis australia pty ltd - alirocumab, quantity: 150 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals. praluent-ccdsv12-piv9-d3-30sep22 page 2 of 35 prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

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

sanofi-aventis australia pty ltd - alirocumab, quantity: 75 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

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

sanofi-aventis australia pty ltd - alirocumab, quantity: 150 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

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

sanofi-aventis australia pty ltd - alirocumab, quantity: 75 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

Israel - English - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 150 mg / 1 ml - alirocumab - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular diseasepraluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Israel - English - Ministry of Health

sanofi israel ltd - alirocumab - solution for injection - alirocumab 75 mg / 1 ml - alirocumab - primary hypercholesterolaemia and mixed dyslipidaemiapraluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:- in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.established atherosclerotic cardiovascular diseasepraluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

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

sanofi-aventis u.s. llc - alirocumab (unii: pp0shh6v16) (alirocumab - unii:pp0shh6v16) - alirocumab 75 mg in 1 ml - praluent® is indicated: - to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. - as an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (ldl-c)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce ldl-c. - as an adjunct to other ldl-c-lowering therapies in adult patients with homozygous familial hypercholesterolemia (hofh) to reduce ldl-c. praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in praluent. hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see warnings and precautions (5.1)]. risk summary available data from clinical trials and postmarketing reports on praluent use in pregnant women are insufficient to evaluate for a drug-associated risk of maj

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

sanofi-aventis australia pty ltd - alirocumab, quantity: 300 mg - injection, solution - excipient ingredients: histidine; sucrose; polysorbate 20; water for injections - primary hypercholesterolaemia praluent is indicated as an adjunct to diet and exercise to reduce ldl-c in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk: - in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with maximum tolerated dose of a statin, - alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach ldl-c goals.,prevention of cardiovascular events praluent is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 pharmacodynamic properties, clinical trials).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alirocumab 150 mg/ml;   - solution for injection - 150 mg/ml - active: alirocumab 150 mg/ml   excipient: histidine polysorbate 20 sucrose water for injection - primary hypercholesterolaemia praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alirocumab 75 mg/ml;   - solution for injection - 75 mg/ml - active: alirocumab 75 mg/ml   excipient: histidine polysorbate 20 sucrose water for injection - primary hypercholesterolaemia praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.