European Union - English - EMA (European Medicines Agency)

amgen europe bv - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - metastatic breast cancerkanjinti is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone-receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancerkanjinti is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc):following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant kanjinti therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.kanjinti should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancerkanjinti in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.kanjinti should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc 2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - other 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.

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. - 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 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. - 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.

European Union - English - EMA (European Medicines Agency)

amgen europe b.v. - panitumumab - colorectal neoplasms - antineoplastic agents - vectibix is indicated for the treatment of adult patients with wild-type ras metastatic colorectal cancer (mcrc): , in first-line in combination with folfox or folfiri., in second-line in combination with folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)., as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Israel - English - Ministry of Health

amgen europe b.v. - cinacalcet hydrochloride 30 mg - film coated tablets - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. mimpara may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.

Israel - English - Ministry of Health

amgen europe b.v. - cinacalcet hydrochloride 60 mg - film coated tablets - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. mimpara may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols, as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.

Israel - English - Ministry of Health

amgen europe b.v. - cinacalcet hydrochloride 90 mg - film coated tablets - cinacalcet - treatment of secondary hyperparathyrodism (hpt) in patients with end-dtage renal disease (esrd) on maintenance dialysis therapy. mimpara may be used as part of a therapeutic regimen including phosphate binders and/or vitamin d sterols as appropriate. reduction of hypercalcaemia in patients with parathyroid carcinoma.