Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية أداتكو - adatco drug store - evolocumab 140 mg/ml - 140 mg/ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية أداتكو - adatco drug store - evolocumab 140 mg/ml - 140 mg/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - evolocumab 140 mg/ml;   - solution for injection - 140 mg - active: evolocumab 140 mg/ml   excipient: glacial acetic acid polysorbate 80 proline sodium hydroxide water for injection - repatha is indicated as an adjunct to diet and exercise in: hypercholesterolaemia repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (ldl-c): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant. homozygous familial hypercholesterolaemia repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

New Zealand - English - Medsafe (Medicines Safety Authority)

amgen new zealand limited - evolocumab 140 mg/ml;   - solution for injection - 140 mg - active: evolocumab 140 mg/ml   excipient: glacial acetic acid polysorbate 80 proline sodium hydroxide water for injection - repatha is indicated as an adjunct to diet and exercise in: hypercholesterolaemia repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (ldl-c): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant. homozygous familial hypercholesterolaemia repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

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

amgen australia pty ltd - evolocumab, quantity: 140 mg - injection, solution - excipient ingredients: proline; glacial acetic acid; polysorbate 80; sodium hydroxide; water for injections - repatha is indicated as an adjunct to diet and exercise in:,prevention of cardiovascular events,repatha is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies (see clinical trials).,primary hypercholesterolaemia,repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (ldl-c): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.,homozygous familial hypercholesterolaemia,repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe b.v. - evolocumab - solution for injection - 140 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe b.v., netherlands - evolocumab - solution for injection - 140 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe b.v., netherlands - evolocumab - solution for injection - 140 mg/ml

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

amgen australia pty ltd - evolocumab, quantity: 140 mg - injection, solution - excipient ingredients: proline; glacial acetic acid; polysorbate 80; sodium hydroxide; water for injections - repatha is indicated as an adjunct to diet and exercise in:,prevention of cardiovascular events,repatha is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies (see clinical trials).,primary hypercholesterolaemia,repatha is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (ldl-c): - in combination with a statin or statin with other lipid lowering therapies, or - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.,homozygous familial hypercholesterolaemia,repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

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

amgen inc - evolocumab (unii: lkc0u3a8nj) (evolocumab - unii:lkc0u3a8nj) - evolocumab 140 mg in 1 ml - repatha is indicated: - in adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization - 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 diet and other ldl-c-lowering therapies in pediatric patients aged 10 years and older with hefh, to reduce ldl-c - as an adjunct to other ldl-c-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (hofh), to reduce ldl-c repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in repatha. serious hypersensitivity reactions including angioedema have occurred in patients treated with repatha [see warnings and precautions (5.1)]. risk summary available data fr