Tanżanija - Ingliż - Tanzania Medicinces & Medical Devices Authority

medtronic africa (pty) ltd, kenya - autolog one source park (wash basin) -

Tanżanija - Ingliż - Tanzania Medicinces & Medical Devices Authority

medtronic africa (pty) ltd, kenya - autotransfusion system -

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - other nervous system drugs - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

Unjoni Ewropea - Ingliż - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - palifermin - mucositis - all other therapeutic products - kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

livanova australia pty ltd -

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd -

Iżrael - Ingliż - 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).

Iżrael - Ingliż - 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).

Iżrael - Ingliż - 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).