Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

celltrion healthcare malaysia sdn. bhd. - rituximab -

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; wegener granulomatosis - antineoplastic agents - ritemvia is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl) ritemvia is indicated for the treatment of previously untreated patients with stage iii, iv follicular lymphoma in combination with chemotherapy.ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.ritemvia 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.ritemvia 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.granulomatosis with polyangiitis and microscopic polyangiitis.ritemvia, 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).

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - mabthera is indicated in adults for the following indications:non‑hodgkin’s lymphoma (nhl)mabthera is indicated for the treatment of previously untreated adult patients with stage iii‑iv follicular lymphoma in combination with chemotherapy.mabthera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.mabthera 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.mabthera 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.mabthera 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)mabthera 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 mabthera or patients refractory to previous mabthera plus chemotherapy.rheumatoid arthritismabthera 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.mabthera 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 polyangiitismabthera, 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).mabthera, 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 vulgarismabthera 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: 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

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;