Israel - English - Ministry of Health

teva israel ltd - valganciclovir as hydrochloride - film coated tablets - valganciclovir as hydrochloride 450 mg - valganciclovir - valganciclovir teva is indicated for the induction and maintenance treatment of cytomegalovirus (cmv) retinitis in patients with acquired immunodeficiency syndrome (aids). valganciclovir teva is indicated for the prevention of cmv disease in cmv-negative patients who have received a solid organ transplant from a cmv-positive donor.

Israel - English - 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 - English - 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 - English - 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 - English - Ministry of Health

teva israel ltd - gefitinib - film coated tablets - gefitinib 250 mg - gefitinib - gefitinib teva is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating mutations of egfr-tk.

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - darunavir - film coated tablets - darunavir 600 mg - darunavir - darunavir teva co-administered with 100 mg ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for over 18 years of age.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - leflunomide - arthritis, rheumatoid - immunosuppressants - leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (dmard).recent or concurrent treatment with hepatotoxic or haematotoxic dmards (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.moreover, switching from leflunomide to another dmard without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib mesilate - dermatofibrosarcoma; gastrointestinal stromal tumors; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - imatinib teva b.v. is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment., paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis., adult patients with ph+ cml in blast crisis., adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy., adult patients with relapsed or refractory ph+ all as monotherapy.,  adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements., adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. , the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib teva b.v. is indicated for: , the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist)., the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment., the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.