Nespo Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

nespo

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - antianemic preparations - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adults and paediatric patients.treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Imlygic Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

imlygic

amgen europe b.v. - talimogene laherparepvec - melanoma - antineoplastic agents - imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage iiib, iiic and ivm1a) with no bone, brain, lung or other visceral disease.

Mimpara Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

mimpara

amgen europe b.v. - cinacalcet hydrochloride - hypercalcemia; parathyroid neoplasms; hyperparathyroidism - calcium homeostasis - secondary hyperparathyroidismadultstreatment of secondary hyperparathyroidism (hpt) in adult patients with end stage renal disease (esrd) on maintenance dialysis therapy.paediatric populationtreatment of secondary hyperparathyroidism (hpt) in children aged 3 years and older with end stage renal disease (esrd) on maintenance dialysis therapy in whom secondary hpt is not adequately controlled with standard of care therapy.mimpara may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate.parathyroid carcinoma and primary hyperparathyroidism in adults.reduction of hypercalcaemia in adult patients with:parathyroid carcinoma;primary hpt for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Neulasta Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

neulasta

amgen europe b.v. - pegfilgrastim - neutropenia; cancer - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Nplate Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

nplate

amgen europe b.v. - romiplostim - purpura, thrombocytopenic, idiopathic - antihemorrhagics - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Prolia Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

prolia

amgen europe b.v. - denosumab - bone resorption; osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. in postmenopausal women prolia significantly reduces the risk of vertebral, non vertebral and hip fractures.treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. in men with prostate cancer receiving hormone ablation, prolia significantly reduces the risk of vertebral fractures.

Xgeva Liên Minh Châu Âu - Tiếng Anh - EMA (European Medicines Agency)

xgeva

amgen europe b.v. - denosumab - fractures, bone; neoplasm metastasis - drugs for treatment of bone diseases - prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.