ישראל - אנגלית - Ministry of Health

amgen europe b.v. - evolocumab - solution for injection - evolocumab 140 mg/ml - evolocumab - hypercholesterolaemia and mixed dyslipidaemiarepatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, 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 hypercholesterolaemia repatha is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.established atherosclerotic cardiovascular disease repatha 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.

ישראל - אנגלית - Ministry of Health

amgen europe b.v. - trastuzumab - powder for concentrate for solution for infusion - trastuzumab 150 mg/vial - trastuzumab - metastatic breast cancer (mbc)kanjinti is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress her2;1. as a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease.2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.3. in combination with an aromatase inhibitor for the treatment of postmenopausal patient with hormone-receptor positive metastatic breast cancer.early breast cancer (ebc)kanjinti is indicated to treat patients with her2 positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines.kanjinti should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)kanjinti in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of 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 fish+ result, or ihc 3+, as determined by an accurate and validated assay.

ישראל - אנגלית - Ministry of Health

amgen europe b.v. - trastuzumab - powder for concentrate for solution for infusion - trastuzumab 420 mg/vial - trastuzumab - metastatic breast cancer (mbc)kanjinti is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress her2;1. as a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease.2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.3. in combination with an aromatase inhibitor for the treatment of postmenopausal patient with hormone-receptor positive metastatic breast cancer.early breast cancer (ebc)kanjinti is indicated to treat patients with her2 positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines.kanjinti should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)kanjinti in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of 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 fish+ result, or ihc 3+, as determined by an accurate and validated assay.

ישראל - אנגלית - Ministry of Health

amgen europe b.v. - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg / 1 ml - bevacizumab - mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.mvasi in addition to platinum - based chemotherapy is indicated for first - line treatment of adult patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology.mvasi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. mvasi as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.mvasi in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who are at high risk for recurrence (residual disease after debulking).mvasi in combination with carboplatin and gemcitabine, is indicated for the treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents.mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin isindicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents.mvasi in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated, in patients who cannot receive platinum therapy, for treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.mvasi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations.

ישראל - אנגלית - Ministry of Health

amgen europe b.v. - adalimumab - solution for injection - adalimumab 50 mg / 1 ml - adalimumab - rheumatoid arthritisamgevita in combination with methotrexate is indicated for:• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.axial spondyloarthritisankylosing spondylitis (as):amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.axial spondyloarthritis without radiographic evidence of as:amgevita is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels, who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs.psoriatic arthritisamgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease to improve physical function.psoriasisamgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.hidradenitis suppurativa (hs)amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic hs therapy.crohn’s diseaseamgevita is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. amgevita is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.ulcerative colitisamgevita is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.uveitisamgevita is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.intestinal behcet's diseaseamgevita is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

ישראל - אנגלית - Ministry of Health

amgen europe b.v. - romiplostim - powder for solution for injection - romiplostim 250 mcg/vial - romiplostim - romiplostim - 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).

ישראל - אנגלית - Ministry of Health

amgen europe b.v. - romiplostim - powder for solution for injection - romiplostim 500 mcg/vial - romiplostim - nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (itp) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

ארמניה - אנגלית - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

amgen europe b.v. - denosumab - solution for s/c injection - 60mg/ml

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

amgen europe b.v. - etelcalcetide hydrochloride - hyperparathyroidism, secondary - anti-parathyroid agents, calcium homeostasis - parsabiv is indicated for the treatment of secondary hyperparathyroidism (shpt) in adult patients with chronic kidney disease (ckd) on haemodialysis therapy.

האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

amgen europe bv - sotorasib - carcinoma, non-small-cell lung - antineoplastic agents - lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (nsclc) with kras g12c mutation and who have progressed after at least one prior line of systemic therapy.