İsrail - İngilizce - Ministry of Health

roche pharmaceuticals (israel) ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - rituximab - mabthera is indicated for the following indications: * non-hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma.mabthera is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy mabthera is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. mabthera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * chronic lymphocytic leukaemia (cll)mabthera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including mabthera or patients refractory to previous mabthera plus chemotherapy.* rheumatoid arthritismabthera is indicated, in combination with methotrexate, to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to one or more tnf antagonist therapies.* granulomatosis with polyangiitis and microscopic polyangiitismabthera, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener’s granulomatosis (wg) and microscopic polyangiitis (mpa). *pemphigus vulgarismabthera is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

İsrail - İngilizce - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for infusion - trastuzumab 440 mg/ml - trastuzumab - trastuzumab - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: 1. as a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. early breast cancer (ebc) :herceptin is indicated to treat patients with her2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. herceptin should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.herceptin should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory fish+ result, or ihc 3+, as determined by an accurate and validated assay

İsrail - İngilizce - Ministry of Health

merck serono ltd - cetuximab - solution for infusion - cetuximab 5 mg/ml - cetuximab - cetuximab - erbitux® is indicated for the treatment of patients with epidermal growth factor receptor (egfr) - expressing, ras wild-type metastatic colorectal cancer• in combination with irinotecan-based chemotherapy• in first-line in combination with folfox• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecanerbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck (scchn)• in combination with radiation therapy for locally advanced disease• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease• as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease

İsrail - İngilizce - Ministry of Health

roche pharmaceuticals (israel) ltd - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - bevacizumab - - avastin in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- avastin in addition to platinum - based chemotherapy is indicated for first - line treatment of patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology. - avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer. - avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- avastin as asingle agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- avastin, in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).- avastin, in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.- avastin ( bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents - avastin ( bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.- bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. - bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

İsrail - İngilizce - 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.

İsrail - İngilizce - Ministry of Health

bayer israel ltd - regorafenib - film coated tablets - regorafenib 40 mg - regorafenib - regorafenib - stivarga is indicated as monotherapy for the treatment of adults patients:- with metastatic colorectal cancer (crc) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vegf therapy,and if kras wild- type, an anti-egfr therapy.- with locally advanced, unresectable or metastatic gastrointestinal stromal tumors (gist) who have been previously treated with imatinib mesylate and sunitinib malate.- hepatocellular carcinoma (hcc) who have been previously treated with sorafenib.

İsrail - İngilizce - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - irinotecan hydrochloride - solution for infusion - irinotecan hydrochloride 20 mg/ml - irinotecan - irinotecan - campto is indicated for the treatment of patients with metastatic colorectal cancer: in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. for the treatment of patients with small cell lung cancer. for the treatment of patients with gastric cancer.irinotecan in combination with leucovorin, oxaliplatin and 5-fluorouracil for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.

İsrail - İngilizce - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy.* adult patients with relapsed or refractory ph + all as monotherapy.* adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

İsrail - İngilizce - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. * adult patients with relapsed or refractory ph + all as monotherapy. * adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

İsrail - İngilizce - Ministry of Health

roche pharmaceuticals (israel) ltd - erlotinib as dihydrochloride - film coated tablets - erlotinib as dihydrochloride 150 mg - erlotinib - erlotinib - non-small cell lung cancer (nsclc):tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations.tarceva is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy.tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer:tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.