European Union - English - EMA (European Medicines Agency)

molmed spa - allogeneic t cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (Δlngfr) and the herpes simplex i virus thymidine kinase (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastic agents - zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (hsct) of adult patients with high-risk haematological malignancies.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells - other drugs for disorders of the musculo-skeletal system - horses - reduction of mild to moderate recurrent lameness associated with non-septic joint inflammation in horses.

United States - English - NLM (National Library of Medicine)

stratatech corporation - viable and metabolically active allogeneic human niks keratinocytes and human dermal fibroblasts cellularized layered scaffold (unii: dyb2t93463) (viable and metabolically active allogeneic human niks keratinocytes and human dermal fibroblasts cellularized layered scaffold - unii:dyb2t93463) - stratagraft is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). do not use in patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin [see description (11)]. risk summary there are no available data regarding stratagraft use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with stratagraft to assess whether it can cause fetal harm when administered to a pregnant woman. in the united states general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there is no information available on the presence of stratagraft in human milk, the effect on the breastfed infant, or the effect on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for stratagraft and any potential adverse effects on the breast-fed infant from stratagraft or from the underlying maternal condition. the safety and effectiveness of stratagraft in pediatric patients (< 18 years) have not been established. eight patients aged 65 years and older were enrolled in study 1. although no differences in safety or efficacy were observed between patients aged 65 years and older and younger patients, the number of patients aged 65 years and older was not sufficient to determine whether they responded differently from younger patients.

United States - English - NLM (National Library of Medicine)

sumitomo pharma america, inc. - allogeneic thymocyte-depleted thymus tissue-agdc (unii: xd66yk3yy3) (allogeneic thymocyte-depleted thymus tissue-agdc - unii:xd66yk3yy3) - rethymic® is indicated for immune reconstitution in pediatric patients with congenital athymia. limitations of use - rethymic is not indicated for the treatment of patients with severe combined immunodeficiency (scid). none. risk summary there are no clinical data with rethymic in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with rethymic. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of cellular components of rethymic in human milk, the effect breastfeeding may have on rethymic, the effect of being breastfed from a mother who received rethymic as a child, or the effects of rethymic on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rethymic and potential adverse effects on the breastfed infant from rethymic. no nonclinical or clinical studies were performed to evaluate the effects of rethymic on fertility. the efficacy and safety of rethymic have been established in pediatric patients with congenital athymia. the efficacy of rethymic has been established in 95 pediatric patients (median age 9 months [range: 33 days to 3 years], including 65 patients age <1 year, 24 patients age 1 to <2 years, and 6 patients age 2 to <3 years at time of treatment) who were treated with rethymic and included in the analysis of efficacy [see clinical studies (14) ]. the safety of rethymic has been established in 105 pediatric patients (median age 9 months [range: 33 days to 16.9 years] at time of treatment) with congenital athymia who were evaluated for safety following rethymic administration. the safety population included 65 patients age <1 year, 27 patients age 1 to <2 years, 9 patients age 2 to <3 years, 1 patient age 3 to <6 years, and 3 patients age 13 to 17 years at time of treatment. within the safety population, survival was similar across age groups. adverse reactions were reported at similar frequencies across the age groups and were generally of similar types and severities. in the clinical studies with rethymic, 10 of 105 patients had impaired renal function at baseline based on elevated screening creatinine [see warnings and precautions (5.4)] . baseline renal function should be considered when selecting immunosuppressants. ensure appropriate involvement of a nephrologist in care of patients with renal impairment.

European Union - English - EMA (European Medicines Agency)

centauri biotech sl - allogeneic equine adipose-derived mesenchymal stem cells - horses - for the treatment osteoarthritis in adult non-food producing horses.

Israel - English - Ministry of Health

takeda israel ltd - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 100 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, children and adolescents (0-18 years) in:• primary immunodeficiency syndromes with impaired antibody production • hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cll), in whom prophylactic antibiotics have failed or are contra-indicated.• hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients.• hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (hsct).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 1000 iu / 0.5 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 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).binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.use should be restricted to patients with moderate anaemia (e.g. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 2000 iu / 1 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 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).binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.use should be restricted to patients with moderate anaemia (e.g. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 30000 iu / 0.75 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 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).binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.use should be restricted to patients with moderate anaemia (e.g. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).

Israel - English - Ministry of Health

novartis israel ltd - epoetin alfa - solution for injection - epoetin alfa 4000 iu / 0.4 ml - erythropoietin - erythropoietin - binocrit® is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (crf):- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis .- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients. binocrit® is indicated 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) for the treatment of anaemia and reduction of transfusion requirements.binocrit® is indicated in adults in a predonation programme to increase the yield of autologous blood.treatment should only be given to patients with moderate anaemia (haemoglobin (hb) concentration range between 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).binocrit® is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions.use should be restricted to patients with moderate anaemia (e.g. hb concentration range between 10 13 g/dl or 6.2 8.1 mmol/l) who do not have an autologous predonation programme available and with an expected blood loss (900 to 1800 ml).