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).

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).

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

roche products pty ltd - rituximab, quantity: 1600 mg - injection - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections - mabthera sc 1600 mg is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.

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

roche products pty ltd - rituximab, quantity: 1400 mg - injection - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections - mabthera sc is indicated for treatment of patients with: - cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin's lymphoma, - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma, - cd 20 positive, diffuse large b-cell non-hodgkin's lymphoma, in combination with chemotherapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - rituximab - mabthera is indicated for the following indications: * non-hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma.mabthera is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy mabthera is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. mabthera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * chronic lymphocytic leukaemia (cll)mabthera 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 mabthera or patients refractory to previous mabthera plus chemotherapy.* rheumatoid arthritismabthera is indicated, in combination with methotrexate, to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to one or more tnf antagonist therapies.* granulomatosis with polyangiitis and microscopic polyangiitismabthera, 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 vulgarismabthera is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

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

sandoz pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; citric acid monohydrate; hydrochloric acid; water for injections; sodium hydroxide; polysorbate 80 - non-hodgkin?s lymphoma (nhl),riximyo (rituximab) is indicated for treatment of patients with:,? cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma,,? cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma,,? cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia (cll),riximyo (rituximab) is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,rheumatoid arthritis (ra),riximyo (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa),riximyo (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

sandoz pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: water for injections; polysorbate 80; citric acid monohydrate; hydrochloric acid; sodium chloride; sodium hydroxide - non-hodgkin?s lymphoma (nhl),riximyo (rituximab) is indicated for treatment of patients with:,? cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma,,? cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma,,? cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia (cll),riximyo (rituximab) is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia in combination with chemotherapy.,rheumatoid arthritis (ra),riximyo (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. rituximab has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa),riximyo (rituximab) in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

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

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) 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 at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.