Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - orphenadrine (citrate); paracetamol - tablets - paracetamol 500 mg; orphenadrine (citrate) 30 mg - orphenadrine, combinations - orphenadrine, combinations - relief of mild to moderate pain of acute musculoskeletal disorders.

Israel - English - Ministry of Health

sanofi israel ltd - sevelamer carbonate anhydrous - film coated tablets - sevelamer carbonate anhydrous 800 mg - sevelamer - sevelamer - for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Israel - English - Ministry of Health

sanofi israel ltd - sevelamer carbonate anhydrous - powder for suspension - sevelamer carbonate anhydrous 2.4 g/sachet - sevelamer - sevelamer - for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.also indicated for the control of hyperphosphataemia in adult patients with chronic kidney diseasenot on dialysis with serum phosphorus ≥ 1.78 mmol/l.should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin d3 or one of its analogues to control the development of renal bone 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 - rosuvastatin as calcium - film coated tablets - rosuvastatin as calcium 10 mg - rosuvastatin - 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.

Israel - English - Ministry of Health

unipharm ltd, israel - rosuvastatin as calcium - film coated tablets - rosuvastatin as calcium 20 mg - rosuvastatin - 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.

Israel - English - Ministry of Health

unipharm ltd, israel - rosuvastatin as calcium - film coated tablets - rosuvastatin as calcium 40 mg - rosuvastatin - 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.

Israel - English - Ministry of Health

unipharm ltd, israel - rosuvastatin as calcium - film coated tablets - rosuvastatin as calcium 5 mg - rosuvastatin - 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. hormozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering treatments (e.g. ldl apheresis) or if such treatment are not appropriate.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - infliximab - powder for concentrate for solution for infusion - infliximab 100 mg/vial - infliximab - * rheumatoid arthritis:remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:• adult patients with active disease when the response to disease modifying antirheumatic drugs (dmards),including methotrexate, has been inadequate.• adult patients with severe, active and progressive disease not previously treated with methotrexate or other dmards.in these patient populations, a reduction in the rate of the progression of joint damage, as measured by x ray,has been demonstrated.* ankylosing spondylitis:remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.* psoriatic arthritis:remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous dmard therapy has been inadequate.* remsima should be administered:• in combination with methotrexate• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x ray in patients with polyarticular symmetrical subtypes of the disease.* psoriasis:remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet a (puva)* adult crohn’s disease remsima is indicated for treatment :• of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.• treatment of fistulising, active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).* ulcerative colitis• remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 mercaptopurine (6 mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.paediatric crohn’s diseaseremsima is indicated for treatment of severe, active crohn’s disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. infliximab has been studied only in combination with conventional immunosuppressive therapy.paediatric ulcerative colitisremsima is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6 mp or aza, or who are intolerant to or have medical contraindications for such therapies.