European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1%. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.2).,

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - carfilzomib - multiple myeloma - antineoplastic agents - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

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).

European Union - English - EMA (European Medicines Agency)

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).

European Union - English - EMA (European Medicines Agency)

amgen europe bv - apremilast - arthritis, psoriatic; psoriasis - immunosuppressants - psoriatic arthritisotezla, alone or in combination with disease modifying antirheumatic drugs (dmards), is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior dmard therapy.psoriasisotezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-a light (puva).

European Union - English - EMA (European Medicines Agency)

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.

European Union - English - EMA (European Medicines Agency)

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.  

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - evolocumab - dyslipidemias; hypercholesterolemia - lipid modifying agents - hypercholesterolaemia and mixed dyslipidaemiarepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.homozygous familial hypercholesterolaemiarepatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.established atherosclerotic cardiovascular diseaserepatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering ldl-c levels, as an adjunct to correction of other risk factors:in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.for study results with respect to effects on ldl-c, cardiovascular events and populations studied see section 5.1.