Israel - English - Ministry of Health

astrazeneca (israel) ltd - durvalumab - solution for infusion - durvalumab 50 mg/ml - durvalumab - urothelial carcinoma imfinzi is indicated for the treatment of patients with pd-l1 high (tumor cell ≥25% or ic ≥25%) locally advanced or metastatic urothelial carcinoma who: - have disease progression during or following platinum-containing chemotherapy. - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. non-small cell lung cancer - imfinzi is indicated for the treatment of patients with unresectable stage iii non-small cell lung cancer (nsclc) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc).biliary tract cancersimfinzi in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (btc).hepatocellular carcinomaimfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - elotuzumab - powder for concentrate for solution for infusion - elotuzumab 300 mg/vial - elotuzumab - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment ofadult patients with relapsed and refractory multiple myeloma who have received at least two priortherapies, including lenalidomide and a proteasome inhibitor, and have demonstrated diseaseprogression on the last therapy.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - elotuzumab - powder for concentrate for solution for infusion - elotuzumab 400 mg/vial - elotuzumab - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.

Israel - English - Ministry of Health

amgen europe b.v. - blinatumomab - powder for concentrate for solution for infusion - blinatumomab 35 mcg / 1 vial - blinatumomab - • blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b- precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options.• blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b-cell precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.• blincyto is indicated as monotherapy for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b precursor all as part of the consolidation therapy.limitations of use: after failure of two previous treatments and with no cns involvement.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - inotuzumab ozogamicin - powder for concentrate for solution for infusion - inotuzumab ozogamicin 1 mg/vial - inotuzumab ozogamicin - besponsa is indicated as monotherapy for the treatment of adults with relapsed or refractory cd22-positive b cell precursor acute lymphoblastic leukaemia (all). adult patients with philadelphia chromosome positive (ph+) relapsed or refractory b cell precursor all should have failed treatment with at least 1 tyrosine kinase inhibitor (tki).

Israel - English - Ministry of Health

j-c health care ltd - daratumumab - concentrate for solution for infusion - daratumumab 20 mg / 1 ml - daratumumab - darzalex is indicated:• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous st em cell transplant.• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy

Israel - English - Ministry of Health

eli lilly israel ltd, israel - ramucirumab - concentrate for solution for infusion - ramucirumab 10 mg/ml - ramucirumab - gastric cancercyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.colorectal cancercyramza, in combination with folfiri (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mcrc) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.non-small cell lung cancercyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung adenocarcinoma with activating epidermal growth factor receptor (egfr) mutations.cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.hepatocellular carcinomacyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (afp) of ≥ 400 ng/ml and who have been previously treated with sorafenib.

Israel - English - Ministry of Health

eli lilly israel ltd - necitumumab - concentrate for solution for infusion - necitumumab 16 mg / 1 ml - necitumumab - portrazza is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer.limitation of use: portrazza is not indicated for treatment of non-squamous non-small cell lung cancer

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen pharmaceutica n.v., belgium - daratumumab - concentrate for solution for infusion - 20 mg/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

janssen pharmaceutica n.v., belgium - daratumumab - concentrate for solution for infusion - 20 mg/ml