European Union - English - 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.

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 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.

Israel - English - 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.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe bv, netherlands - trastuzumab - powder for concentrate for solution for infusion - 150 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe bv, netherlands - adalimumab - solution for injection - 40 mg, mg/ml,

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

amgen europe bv, netherlands - adalimumab - solution for injection - 40 mg, mg/ml,

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - water for injections -

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - water for injections -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

amgen biopharmaceuticals malaysia sdn bhd - romosozumab -