Европейский союз - английский - EMA (European Medicines Agency)

xbiotech germany gmbh - human igg1 monoclonal antibody specific for human interleukin-1 alpha - colorectal neoplasms - antineoplastic agents - treatment of metastatic colorectal cancer

Новая Зеландия - английский - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 10 mg/ml (murine/human monoclonal antibody);  ;  ;   - concentrate for infusion - 10 mg/ml - active: rituximab 10 mg/ml (murine/human monoclonal antibody)       excipient: citric acid hydrochloric acid polysorbate 80 sodium chloride sodium citrate dihydrate water for injection - mabthera is indicated for the treatment of patients with: · cd20 positive, previously untreated low-grade or follicular, b-cell non-hodgkin's lymphoma in combination with chemotherapy. · cd20 positive, relapsed or chemoresistant low-grade or follicular, b-cell non-hodgkin's lymphoma. · cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. mabthera is indicated for maintenance treatment of patients with cd20 positive, low grade or follicular, b-cell non-hodgkin's lymphoma.

Ирландия - английский - Ecolab

ecolab deutschland gmbh -

Сингапур - английский - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - pathology - monoclonal mouse anti-human pd-l1, clone 22c3 is intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissues. monoclonal mouse anti-human pd-l1, clone 22c3 is intended for qualitative pd-l1 testing and indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). pd-l1 protein expression in nsclc is determined by using tumor proportion score (tps), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. the specimen should be considered to have pd-l1 expression if tps ≥ 1% and high pd-l1 expression if tps ≥ 50%.

Израиль - английский - Ministry of Health

takeda israel ltd - factor viii (human) - powder for solution for injection - factor viii (human) 220 - 2000 iu/vial - coagulation factor viii - coagulation factor viii - hemophilia a - for the prevention and control of hemorrhagic episodes

Сингапур - английский - HSA (Health Sciences Authority)

biomed diagnostics pte ltd - hematology - anti-a, anti-b or anti-a,b murine monoclonal blood grouping reagents are intended for use in slide, tube and microplate tests and provide a specific, qualitative test for the detection of the a and/or b antigens on human red blood cells.

Сингапур - английский - HSA (Health Sciences Authority)

agilent technologies singapore (international) pte ltd - immunology - for in vitro diagnostic use. flex monoclonal mouse anti-cytomegalovirus, clone cch2 + ddg9 ready-to-use, is intended for use in immunohistochemistry together with autostainer instruments. this antibody is useful for the identification of human cytomegalovirus (hcmv)-infected tissues. the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Сингапур - английский - HSA (Health Sciences Authority)

biomed diagnostics pte ltd - hematology - the test used with this blood grouping reagent is based on the principle of direct hemagglutination. incubation of test red cells with novaclone™ anti-d igm + igg monoclonal blend will result in a specific antigen-antibody reaction if the corresponding d (rh1) antigen is present on the red cells.

Сингапур - английский - 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.

Сингапур - английский - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - pathology - ventana anti-helicobacter pylori (sp48) rabbit monoclonal primary antibody) is intended for laboratory use in the qualitative immunohistochemical detection of helicobacter pylori by light microscopy in sections of formalin-fixed, paraffin-embedded gastric biopsy tissue stained on a benchmark ihc/ish instrument. immuno¬histochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. 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.