Iisrael - inglise - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 10 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva 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: simvastatin-teva 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) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios.homozygous familial hypercholesterolemia: simvastatin-teva 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). simvastatin-teva is indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Iisrael - inglise - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 80 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva 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: simvastatin-teva 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) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva 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). simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia (fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Iisrael - inglise - Ministry of Health

teva israel ltd - simvastatin - tablets - simvastatin 40 mg - simvastatin - simvastatin - coronary heart disease : in patients with coronary heart disease and hypercholesterolemia simvastatin-teva 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: simvastatin-teva 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) simvastatin-teva therefore lowers the ldl-c/hdl-c and the total-c/hdl-c ratios. homozygous familial hypercholesterolemia: simvastatin-teva 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). simvastatin-teva is indicated for the treatment of patients with hypertriglyceridemia ( fredrickson type iv hyperlipidemia). dysbetalipoproteinemia (fredrickson type iii hyperlipidemia): simvastatin-teva is also indicated for the treatment of patients with primary dysbetalipoproteinemia (fredrickson type iii hyperlipidemia).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 477.877 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 477.877 mg (equivalent: imatinib, qty 400 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - imatinib mesilate, quantity: 119.469 mg (equivalent: imatinib, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; crospovidone; magnesium stearate; purified water; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; macrogol 4000; polyvinyl alcohol - 1) imatinib-teva (imatinib) is indicated for the treatment of patients with chronic myeloid leukaemia (cml). 2) imatinib-teva (imatinib) is indicated for the treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. 3) imatinib-teva (imatinib) is indicated for the treatment of adult patients with relapsed or refractory ph+all as monotherapy. 4) imatinib-teva (imatinib) is indicated for the treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene rearrangements, where conventional therapies have failed. 5) imatinib-teva (imatinib) is indicated for the treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed. 6) imatinib-teva (imatinib) is indicated for the treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). 7) imatinib-teva (imatinib) is indicated for the treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) 8) imatinib-teva (imatinib) is indicated for the adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist. 9) imatinib-teva (imatinib) is indicated for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Iisrael - inglise - 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.

Iisrael - inglise - 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.

Iisrael - inglise - 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.