Israel - English - Ministry of Health

dexcel pharma technologies ltd - atorvastatin as calcium - tablets - atorvastatin as calcium 10 mg - atorvastatin - atorva - dex is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorva - dex is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorva - dex is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease, litorva is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

dexcel pharma technologies ltd - atorvastatin as calcium - tablets - atorvastatin as calcium 20 mg - atorvastatin - atorva - dex is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorva - dex is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorva - dex is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease, litorva is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

dexcel pharma technologies ltd - atorvastatin as calcium - tablets - atorvastatin as calcium 40 mg - atorvastatin - atorva - dex is indicated as an adjunct to diet for reduction of elevated total cholesterol ldl- cholesterol apolipoprotein b and triglycerides and to increase hdl cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types iia and iib of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. atorva - dex is also indicated to reduce total-c and ldl -c in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. ldl apheresis) or if such treatments are unavailable. pediatric patients (10-17 years of age) : atorva - dex is indicated as an adjunct to diet to reduce total -c ldl-c and apo b levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. ldl-c remains >or = 190 mg/dl or 2. ldl-c remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cvd risk factors are present in the pediatric patient. prevention of cardiovascular and/or cerebrovascular event sush as mi or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. in patients with clinically evident coronary heart disease, litorva is indicated to : reduce the risk of non-fatal myocardial infarction. reduce the risk of fatal and non fatal stroke. reduce the risk for revascularization procedures. reduce the risk of hospitalization for chf. reduce the risk of angina.

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 20 mg - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures - reduce the risk of stroke and transient ischemic attacks (tia's). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia): simvaxon is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvaxon is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 40 mg - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: - reduce the risk of total mortality by reducing coronary death - reduce the risk of non-fatal myocardial infarction - reduce the risk for undergoing myocardial revascularization procedures - reduce the risk of stroke and transient ischemic attacks (tia's). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia ( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measure

Israel - English - Ministry of Health

dexcel pharma technologies ltd - simvastatin - caplets - simvastatin 80 mg - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvaxon is indicated to: reduce the risk of total mortality by reducing coronary death reduce the risk of non-fatal myocardial infarction reduce the risk for undergoing myocardial revascularization procedures.reduce the risk of stroke and transient ischemic attacks (tia). hyperlipidemia: simvaxon is indicated as an adjunct to diet to reduce elevated total-c ldl-c apo b and tg and to increase hdl-c in patients with primary hypercholesterolemia( heterozygous familial and nonfamilial) and mixed dyslipidemia (frederickson types iia and iib) simvaxon therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvaxon is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol ldl-cholesterol and apolipoprotein b in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. hypertriglyceridemia (fredrickson type iv hyperlipidemia). simvaxon is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).in patients at a high risk of coronary events because of existing coronary heart disease diabetes peripheral vessel disease history of stroke or other cerebrovascular disease simvaxon is indicated to: - reduce the risk of total mortality by reducing chd deaths. - reduce the risk of non-fatal myocardial infarction and stroke. - reduce the need for coronary and non-coronary revascularization procedures

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

dexcel-pharma ltd - losartan potassium - oral tablet - 25mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

dexcel-pharma ltd - losartan potassium - oral tablet - 50mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

kent pharma (uk) ltd - nicorandil - oral tablet - 20mg

Ireland - English - HPRA (Health Products Regulatory Authority)

dexcel-pharma limited - irbesartan - film coated tablet - 75 milligram