Australia - English - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; dimethyl sulfoxide; sodium chloride - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (mcl), who have received two or more lines of therapy, including a btk inhibitor, unless ineligible or intolerant to treatment with a btk inhibitor.

Australia - English - Department of Health (Therapeutic Goods Administration)

specialised therapeutics alim pty ltd - tafasitamab, quantity: 200 mg - injection, powder for - excipient ingredients: polysorbate 20; citric acid monohydrate; trehalose dihydrate; sodium citrate dihydrate - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.

Israel - English - Ministry of Health

gilead sciences israel ltd - anti-cd19 car t cells - dispersion for infusion - anti-cd19 car t cells - acute lymphoblastic leukaemia tecartus is indicated for the treatment of adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).mantle cell lymphoma tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton's tyrosine kinase (btk) inhibitor unless ineligible to btk inhibitor •limitation of use : tecartus is not indicated for the treatment of patients with active central nervous system lymphoma

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 5000 iu / 0.3 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency* and are receiving anti-tumor therapy. * deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 10000 iu / 0.6 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with chemotherapy. treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency* and are receiving anti-tumor therapy. * deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 4000 iu / 0.3 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 6000 iu / 0.3 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis.increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with platinum-based chemotherapy prone to induce anemia (cisplatin 75 mg/m2/cycle carboplatin: 350 mg/m2/cycle). treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - epoetin beta - solution for injection - epoetin beta 30000 iu / 0.6 ml - erythropoietin - erythropoietin - treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis. treatment of symptomatic renal anemia in patients not yet undergoing dialysis. increasing the yield of autologous blood from patients in a pre-donation program. its use in this indication must be balanced against the reported increased risk of thromboembolic events. treatment should only be given to patients with moderate anemia (hb 10-13 g/dl (6.21- 8.07 mmol/l) no iron deficiency) or when blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). treatment of anemia in adult patients with solid tumors and treated with chemotherapy . treatment of anemia in adult patients with multiple myeloma low grade non-hodgkin's lymphoma or chronic lymphocytic leukemia who have a relative erythropoietin deficiency and are receiving anti-tumor therapy. deficiency is defined as an inappropriately low serum erythropoietin level in relation to the degree of anemia.

European Union - English - EMA (European Medicines Agency)

medice arzneimittel pütter gmbh co. kg - epoetin alfa - anemia; kidney failure, chronic; cancer - antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients:treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy).abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. its use in this indication must be balanced against the reported risk of thromboembolic events. treatment should only be given to patients with moderate anaemia (haemoglobin (hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. use should be restricted to patients with moderate anaemia (e.g. hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex 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 stem 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.in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).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.al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.