Canada - English - Health Canada

alkermes inc - naproxen (naproxen sodium) - tablet (extended-release) - 375mg - naproxen (naproxen sodium) 375mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

alkermes inc - naproxen (naproxen sodium) - tablet (extended-release) - 500mg - naproxen (naproxen sodium) 500mg - other nonsteroidal antiimflammatory agents

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - lymphoma, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies. 

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)

baxalta innovations gmbh - human normal immunoglobulin - immunologic deficiency syndromes - immune sera and immunoglobulins, - 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).