Israel - engelsk - Ministry of Health

teva israel ltd - entecavir as monohydrate - film coated tablets - entecavir as monohydrate 1 mg - entecavir - entecavir teva is indicated for the treatment of chronic hepatitis b virus (hbv) infection in adults with: - compensated liver disease and evidence of active viral replication, and persistently elevated serum alanine aminotransferase (alt) levels. - decompensated liver disease.

Israel - engelsk - Ministry of Health

teva pharmaceutical industries ltd, israel - duloxetine as hydrochloride - capsules - duloxetine as hydrochloride 60 mg - duloxetine - duloxetine dr teva is indicated for:- the treatment of major depressive episodes. - the management of neuropathic pain associated with diabetic peripheral neuropathy. - the treatment of generalized anxiety disorder (gad).- the management of fibromyalgia. - the management of chronic muscoskeletal pain when other therapies have failed or are contra-indicated. this has been established in studies in patients with chronic low ‎back pain (clbp) and chronic pain due to osteoarthritis.

Israel - engelsk - Ministry of Health

teva israel ltd - cinacalcet as hydrochloride - tablets - cinacalcet as hydrochloride 30 mg - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Israel - engelsk - Ministry of Health

teva israel ltd - cinacalcet as hydrochloride - tablets - cinacalcet as hydrochloride 60 mg - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Israel - engelsk - Ministry of Health

teva israel ltd - cinacalcet as hydrochloride - tablets - cinacalcet as hydrochloride 90 mg - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. cinacalcet teva may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.reduction of hypercalcaemia in patients with:• parathyroid carcinoma.• primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Israel - engelsk - Ministry of Health

abic marketing ltd, israel - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 100 mg - pemetrexed - malignant pleural mesothelioma :pemetrexed teva in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. non-small cell lung cancer: pemetrexed teva in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed teva is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed teva is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Israel - engelsk - Ministry of Health

abic marketing ltd, israel - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 1000 mg - pemetrexed - malignant pleural mesothelioma :pemetrexed teva in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. non-small cell lung cancer: pemetrexed teva in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed teva is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed teva is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Israel - engelsk - Ministry of Health

abic marketing ltd, israel - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 500 mg - pemetrexed - malignant pleural mesothelioma :pemetrexed teva in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curatible surgery. non-small cell lung cancer: pemetrexed teva in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed teva is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed teva is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Israel - engelsk - Ministry of Health

teva pharmaceutical industries ltd, israel - clopidogrel as bisulfate - tablets - clopidogrel as bisulfate 75 mg - clopidogrel - prevention of atherotrobmotic eventsclopidogrel is indicated in :• adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.• adult patients suffering from acute coronary syndrome- non-st segment elevation acute coronary syndrome (unstable angina/non-q-wave myocardial infarction (mi)), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapyprevention of atherotrobmotic and thromboembolic events in atrial fibrillation: in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for the treatment with vitamin k antagonists (vka) anti-thrombin or anti factor xa, and who have a low bleeding risk, clopid

Israel - engelsk - Ministry of Health

abic marketing ltd, israel - everolimus - tablets - everolimus 10 mg - everolimus - • for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease. the safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established.• for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.• everolimus teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.• everolimus teva is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.•treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease