Singapore - English - HSA (Health Sciences Authority)

leica microsystems (sea) pte ltd - immunology - it is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. pgr clone 16 specifically binds to the pgr antigen located in the nucleus of pgr positive normal and neoplastic cells. pgr clone 16 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. 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.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig  - rituximab - leukemia, lymphocytic, chronic, b-cell; arthritis, rheumatoid; microscopic polyangiitis; pemphigus - antineoplastic agents - ruxience is indicated in adults for the following indications:non‑hodgkin’s lymphoma (nhl)ruxience is indicated for the treatment of previously untreated patients with stage iii‑iv follicular lymphoma in combination with chemotherapy.ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.ruxience monotherapy is indicated for treatment of patients with stage iii‑iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.ruxience is indicated for the treatment of patients with cd20 positive diffuse large b cell non‑hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.chronic lymphocytic leukaemia (cll)ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.rheumatoid arthritisruxience in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease‑modifying anti‑rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies.ruxience 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.granulomatosis with polyangiitis and microscopic polyangiitisruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).pemphigus vulgarisruxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Israel - English - Ministry of Health

promedico ltd - selinexor - tablets - selinexor 20 mg - selinexor - multiple myeloma• xpovio® in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• xpovio in combination with dexamethasone is indicated for the treatment of adult patients with relapsed refractory multiple myeloma (rrmm) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (pi), at least one immunomodulatory agent (imid), and an anti- cd38 monoclonal antibody (mab).diffuse large b-cell lymphomaxpovio is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl), not otherwise specified, including dlbcl arising from follicular lymphoma, after at least 2 lines of systemic therapy.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

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

janssen-cilag pty ltd - teclistamab, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; sucrose; disodium edetate; sodium acetate trihydrate; polysorbate 20; water for injections - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

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

janssen-cilag pty ltd - teclistamab, quantity: 153 mg - injection, solution - excipient ingredients: polysorbate 20; sodium acetate trihydrate; glacial acetic acid; sucrose; water for injections; disodium edetate - tecvayli as monotherapy has provisional approval in australia and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody.,the decision to approve this indication has been made on the basis of the overall response rate in a single arm study. continued approval of this indication depends on verification and description of benefit in confirmatory trials.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - anti-beta hcg monoclonal antibody - pregnancy test kit - active: anti-beta hcg monoclonal antibody

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - anti-beta hcg monoclonal antibody - pregnancy test kit - active: anti-beta hcg monoclonal antibody

New Zealand - English - Medsafe (Medicines Safety Authority)

new zealand diagnostics ltd - anti-beta hcg monoclonal antibody - pregnancy test kit - active: anti-beta hcg monoclonal antibody

New Zealand - English - Medsafe (Medicines Safety Authority)

new zealand diagnostics ltd - anti-beta hcg monoclonal antibody - pregnancy test kit - active: anti-beta hcg monoclonal antibody