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.

Israel - English - Ministry of Health

amgen europe b.v. - evolocumab - solution for injection - evolocumab 140 mg/ml - evolocumab - hypercholesterolaemia and mixed dyslipidaemiarepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, 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. homozygous familial hypercholesterolaemia repatha is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.established atherosclerotic cardiovascular disease repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial 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.

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

klik systems australia pty limited -

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

klik systems australia pty limited -

Israel - English - Ministry of Health

novartis israel ltd - inclisiran as sodium - solution for injection - inclisiran as sodium 189 mg/ml - inclisiran - leqvio 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.

European Union - English - EMA (European Medicines Agency)

viatris healthcare limited - fenofibrate, simvastatin - dyslipidemias - lipid modifying agents - cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase hdl c levels when ldl c levels are adequately controlled with the corresponding dose of simvastatin monotherapy.

European Union - English - EMA (European Medicines Agency)

laboratoires smb s.a. - fenofibrate, pravastatin - dyslipidemias - lipid modifying agents - pravafenix is indicated for the treatment of high-coronary-heart-disease (chd)-risk adult patients with mixed dyslipidaemia characterised by high triglycerides and low hdl-cholesterol (c) levels whose ldl-c levels are adequately controlled while on a treatment with pravastatin-40-mg monotherapy.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

colgate-palmolive (pty) ltd - solution - each 10 g solution contains sodium fluoride 2,5 mg triclosan 3 mg

Israel - English - Ministry of Health

astrazeneca (israel) ltd - rosuvastatin as calcium - film coated tablets - rosuvastatin as calcium 10 mg - rosuvastatin - rosuvastatin - treatment of adults with:• primary hypercholesterolaemia (type iia including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type iib) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise weight reduction) is inadequate.• homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or if such treatments are not appropriate