نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) - powder for infusion - 160 mg - active: trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) excipient: polysorbate 20 sodium hydroxide succinic acid sucrose - kadcyla as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included her2-targeted therapy.

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

roche singapore pte. ltd. - trastuzumab emtansine - injection, powder, for solution - 160 mg/vial - trastuzumab emtansine 160 mg/vial

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

roche singapore pte. ltd. - trastuzumab emtansine - injection, powder, for solution - 100 mg/vial - trastuzumab emtansine 100 mg/vial

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - pathology - ventana anti-her2/neu (4b5) rabbit monoclonal primary antibody is intended for the semi-quantitative detection of her2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue stained on a benchmark ihc/ish instrument. this product is indicated as an aid in the assessment of breast and gastric cancer patients for whom herceptin® (trastuzumab) treatment is considered and for breast cancer patients for whom kadcyla® (ado-trastuzumab emtansine) or perjeta® (pertuzumab) treatments are being considered. this product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. this antibody is intended for in vitro diagnostic (ivd) use.

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

pfizer private limited - tucatinib (eqv tucatinib hemi ethanolate) - tablet, film coated - tucatinib (eqv tucatinib hemi ethanolate) 150mg

سنغافورة - الإنجليزية - HSA (Health Sciences Authority)

pfizer private limited - tucatinib (eqv tucatinib hemi ethanolate) - tablet, film coated - tucatinib (eqv tucatinib hemi ethanolate) 50mg

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1056 - immunohistology cell marker ivds - immunohistochemical staining of tissues for her-2 antigen as an aid in identifying patients eligible for treatment with nominated therapies in selected indications. ventana her2 (4b5) rabbit monoclonal primary antibody rxdx is intended for the semi-quantitative detection of her2 antigen by immunohistochemistry (ihc) in sections of formalin-fixed, paraffin-embedded breast and gastric tissue stained on a benchmark ihc/ish instrument. this ihc device is indicated for identifying breast cancer patients who are eligible for treatment with trastuzumab, pertuzumab, trastuzumab emtansine, or famtrastuzumab deruxtecan-nxki. additionally, this ihc device is indicated as an aid in the assessment of gastric cancer patients for whom trastuzumab treatment is being considered.