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Xgeva | European Medicines Agency (EMA) Xgeva is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone These complications include fractures (breaks in the bone), spinal compression (pressure on the spinal cord caused by damage to the surrounding bone), or bone problems requiring radiotherapy (treatment with radiation) or surgery
Xgeva, INN-denosumab - European Medicines Agency XGEVA was studied in an open-label trial that enrolled 28 skeletally mature adolescents with giant cell tumour of bone Based on these limited data, the adverse event profile appeared to be similar to adults
Xgeva, INN-denosumab - European Medicines Agency In this study, Xgeva reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid In another study involving 1,718 patients with newly diagnosed multiple myeloma, Xgeva was as effective as zoledronic acid in delaying the patients’ first skeletal-related event Treatment of giant cell tumour of bone
xgeva INN-denosumab - European Medicines Agency Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been
Xgeva, INN-denosumab - European Medicines Agency In the XGEVA clinical development program, Study 20060359 is the only XGEVA clinical study to systematically collect centrally-reviewed imaging (yearly skeletal scintigraphy and CT MRI imaging) and clinical fracture data during a post-treatment follow-up period (up to 5 years of follow-up after completion of treatment)
Xgeva, INN-denosumab - European Medicines Agency Wie wirkt Xgeva? Der Wirkstoff in Xgeva, Denosumab, ist ein monoklonaler Antikörper, der so entwickelt wurde, dass er ein bestimmtes Protein mit der Bezeichnung RANKL erkennt und daran bindet Dieses Protein aktiviert die Osteoklasten, die Zellen im Körper, die am Abbau des Knochengewebes beteiligt sind
Xgeva, INN-denosumab All Xgeva indications Moreover, in the most recent PSUR (EMEA H C PSUSA 00009119 201809), the MAH reported on plans to add alopecia to the CDS, as new adverse drug reaction (ADRs) associated with denosumab therapy and submit this in a variation
XGEVA, INN-denosumab - European Medicines Agency Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the
XGEVA, INN-denosumab - European Medicines Agency Please refer to Xgeva PSUSA-9119-201409 EPAR: Scientific conclusions and grounds recommending the variation to the modification of an approved one based on prostate-specific antigen (PSA) doubling time of 6 months or less”