Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - pertuzumab - concentrate for solution for infusion - pertuzumab 420 mg / 14 ml - pertuzumab - pertuzumab - early breast cancer perjeta is indicated for use in combination with trastuzumab and chemotherapy for: • the neoadjuvant treatment of patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. • the adjuvant treatment of patients with her2-positive early breast cancer (node positive) at high risk of recurrence .metastatic breast cancerperjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for injection - trastuzumab 600 mg / 5 ml - trastuzumab - breast cancermetastatic breast cancerherceptin is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancerherceptin is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) . - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. - in combination with neoadjuvant chemotherapy followed by adjuvant herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameterherceptin should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay .

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - atezolizumab - concentrate for solution for infusion - atezolizumab 60 mg / 1 ml - urothelial carcinoma• tecentriq (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a pd-l1 expression ≥ 5%.• tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- non-small cell lung cancer •tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an approved test, with no egfr or alk genomic tumor aberrations.•tecentriq, in combination with paclitaxel protein-bound and carboplatin,

Israel - English - Ministry of Health

unipharm ltd, israel - losartan potassium - tablets - losartan potassium 100 mg - losartan - hypertension: lotan 100 is indicated for the treatment of hypertension. heart failure:lotan 100 is indicated for the treatment of heart failure, when treatment with an ace inhibitor is not appropriate. switching patients with heart failure who are stable on an ace inhibitor to lotan 100 is not recommended. renal protection in type-2 diabetic patients with proteinuria: lotan 100 is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria. reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy. lotan 100 is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy. the benefit of lotan 100 on the primary deposite endpoint was largely driven by reduction in the risk of stroke.

Israel - English - Ministry of Health

unipharm ltd, israel - losartan potassium - tablets - losartan potassium 12.5 mg - losartan - heart failure: lotan 12.5 is indicated for the treatment of heart failure, when treatment with an ace inhibitor is no longer considered appropriate. switching patients with heart failure who are stable on an ace inhibitor to lotan 12.5 mg is not recommended

Israel - English - Ministry of Health

unipharm ltd, israel - losartan potassium - tablets - losartan potassium 50 mg - losartan - hypertension: lotan 50 mg is indicated for the treatment of hypertensionheart failure: lotan 50 mg is indicated for the treatment of heart failure, usually in addition to diuretics and/or digitalis, if use of an ace inhibitor is not appropriate.switching patients with heart failure who are stable on an ace inhibitor to lotan 50 mg is not recommended.renal protection in type-2 diabetic patients with proteinuria: lotan 50 mg is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria.reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy. lotan 50 mg is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy.the benefit of lotan 50 mg on the primary deposite endpoint was largely driven by reduction in the risk of stroke.

Israel - English - Ministry of Health

unipharm ltd, israel - losartan potassium - tablets - losartan potassium 100 mg - losartan - hypertension: lotan 100 is indicated for the treatment of hypertension. heart failure:lotan 100 is indicated for the treatment of heart failure, when treatment with an ace inhibitor is not appropriate. switching patients with heart failure who are stable on an ace inhibitor to lotan 100 is not recommended. renal protection in type-2 diabetic patients with proteinuria: lotan 100 is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria. reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy. lotan 100 is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy. the benefit of lotan 100 on the

Israel - English - Ministry of Health

unipharm ltd, israel - losartan potassium - tablets - losartan potassium 12.5 mg - losartan - heart failure: lotan 12.5 is indicated for the treatment of heart failure, when treatment with an ace inhibitor is no longer considered appropriate. switching patients with heart failure who are stable on an ace inhibitor to lotan 12.5 mg is not recommended

Israel - English - Ministry of Health

unipharm ltd, israel - losartan potassium - tablets - losartan potassium 50 mg - losartan - hypertension: lotan 50 mg is indicated for the treatment of hypertensionheart failure: lotan 50 mg is indicated for the treatment of heart failure, usually in addition to diuretics and/or digitalis, if use of an ace inhibitor is not appropriate.switching patients with heart failure who are stable on an ace inhibitor to lotan 50 mg is not recommended.renal protection in type-2 diabetic patients with proteinuria: lotan 50 mg is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria.reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy. lotan 50 mg is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventri

Israel - English - Ministry of Health

unipharm ltd, israel - ezetimibe - tablets - ezetimibe 10 mg - ezetimibe - primary hypercholesterolemia: ezecor administered with an hmg-coa reductase inhibitor (statin) or alone are indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. homozygous familial hypercholesterolemia (hofh): ezecor administered with a statin are indicated for use in patients with hofh.patients may also receive adjunctive treatments (e.g. ldl apheresis).homozygous sitosterolemia (phytosterolemia): ezecor are indicated for use in patients with homozygous familial sitosterolemia.