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

roche products pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; water for injections; citric acid; polysorbate 80; hydrochloric acid; sodium citrate dihydrate; sodium hydroxide - non-hodgkin's lymphoma: mabthera 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: mabthera is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy. rheumatoid arthritis: mabthera (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. mabthera 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 poly

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastic agents - rituzena is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rituzena is indicated for the treatment of previously untreated patients with stage iii iv follicular lymphoma in combination with chemotherapy.rituzena 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.rituzena 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)rituzena 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 rituzenaor patients refractory to previous rituzena plus chemotherapy.granulomatosis with polyangiitis and microscopic polyangiitisrituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).

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

roche products pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: polysorbate 80; sodium chloride; water for injections; sodium hydroxide; hydrochloric acid; citric acid; sodium citrate dihydrate - non-hodgkin's lymphoma: ristova 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: ristova is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy. rheumatoid arthritis: ristova (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. ristova 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 po

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

roche products pty ltd - rituximab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: sodium chloride; water for injections; citric acid; polysorbate 80; hydrochloric acid; sodium citrate dihydrate; sodium hydroxide - non-hodgkin's lymphoma: ristova 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: ristova is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy. rheumatoid arthritis: ristova (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. ristova 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 po

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

recordati rare diseases australia pty ltd - dinutuximab beta, quantity: 4.5 mg/ml - solution - excipient ingredients: polysorbate 20; hydrochloric acid; sucrose; water for injections; histidine - qarziba is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.

Israel - English - Ministry of Health

novartis israel ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg / 1 ml - rituximab - rixathon is indicated for the following indications: * non-hodgkin’s lymphoma (nhl): rixathon is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma. rixathon is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapy.rixathon is indicated for the treatment of patients with cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop chemotherapy. rixathon maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. * 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 rixathon or patients refractory to previous rixathon plus chemotherapy.* granulomatosis with polyangiitis and microscopic polyangiitis: rixathon, 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):rixathon is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv)

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 tuxella 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 , chronic lymphocytic leukaemia tuxella 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)

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 tuxella 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 , chronic lymphocytic leukaemia tuxella 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)

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: water for injections; polysorbate 80; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma ritemvia 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;

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 ritemvia 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;