Kanjinti European Union - English - EMA (European Medicines Agency)

kanjinti

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.

OTEZLA 10 MG Israel - English - Ministry of Health

otezla 10 mg

amgen europe b.v. - apremilast - film coated tablets - apremilast 10 mg - apremilast - otezla is indicated:- for treatment of adult patients with active psoriatic arthritis (psa).- for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy (psor).- for the treatment of adult patients with oral ulcers associated with behçet’s disease (bd).