European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - carcinoma, non-small-cell lung - antineoplastic and immunomodulating agents, monoclonal antibodies - nivolumab bms is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (nsclc) after prior chemotherapy in adults.

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; wegener granulomatosis; leukemia, lymphocytic, chronic, b-cell; microscopic polyangiitis - antineoplastic agents - truxima is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)truxima is indicated for the treatment of previously untreated patients with stage iii iv follicular lymphoma in combination with chemotherapy.truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.truxima monotherapy is indicated for treatment of patients with stage iii iv follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.truxima 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)truxima 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 truxima or patients refractory to previous truxima plus chemotherapy.rheumatoid arthritistruxima 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.truxima 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 polyangiitistruxima, 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 vulgaristruxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - blitzima is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)blitzima is indicated for the treatment of previously untreated patients with stage iii-iv follicular lymphoma in combination with chemotherapy.blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.blitzima monotherapy is indicated for treatment of patients with stage iii-iv follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.blitzima 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)blitzima 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 blitzima or patients refractory to previous blitzima plus chemotherapy.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - antineoplastic agents - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy.rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll).chronic lymphocytic leukaemia (cll)rixathon in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. 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.see section 5.1 for further information.rheumatoid arthritisrixathon 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.rituximab 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 polyangiitisrixathon, 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).rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa.pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - antineoplastic agents - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy.riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll).chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. 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.see section 5.1 for further information.rheumatoid arthritisriximyo 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.rituximab 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 polyangiitisriximyo, 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).riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa.pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

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

ge healthcare australia pty ltd - indium (111in) chloride, quantity: 370 mbq/ml - injection, solution - excipient ingredients: hydrochloric acid - for the radiolabelling of approved polyaminocarboxylic acid derivatised monoclonal antibody preparations for in vivo diagnostic imaging procedures.

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

ge healthcare australia pty ltd - indium (111in) chloride, quantity: 370 mbq/ml - injection, solution - excipient ingredients: hydrochloric acid - for the radiolabelling of approved polyaminocarboxylic acid derivatised monoclonal antibody preparations for in vivo diagnostic imaging procedures.

Israel - English - Ministry of Health

padagis israel agencies ltd, israel - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - truxima is indicated in adults for the following indications: * non-hodgkin’s lymphoma (nhl) truxima is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma. truxima is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy. truxima is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.* chronic lymphocytic leukaemia (cll)truxima 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.* granulomatosis with polyangiitis and microscopic polyangiitistruxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with granulomatosis with polyangiitis (gpa) (wegener’s granulomatosis (wg)) and microscopic polyangiitis (mpa).*pemphigus vulgaris (pv):truxima is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

Singapore - English - HSA (Health Sciences Authority)

leica microsystems (sea) pte ltd - immunology - for the qualitative identification by light microscopy of cytokeratin (8/18) molecules in paraffin sections. 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. for in vitro diagnostic use.

Singapore - English - HSA (Health Sciences Authority)

leica microsystems (sea) pte ltd - immunology - it is intended for laboratory use to qualitatively identify by light microscopy, human estrogen receptor (er) antigen in sections of formalin fixed, paraffin embedded tissue. er clone 6f11 specifically binds to the er antigen located in the nucleus of er positive normal and neoplastic cells. er 6f11 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.