Unió Europea - anglès - 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 - anglès - 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)

Israel - anglès - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - rituximab - concentrate for solution for infusion - rituximab 10 mg/ml - rituximab - ruxience is indicated for:non-hodgkin’s lymphoma (nhl):ruxience is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, b-cell non-hodgkin’s lymphoma.ruxience is indicated for the treatment of previously untreated patients with low-grade or follicular lymphoma in combination with chemotherapyruxience is indicated for the treatment of patients with cd20 positive diffuse large b-cell nonhodgkin's lymphoma in combination with chop chemotherapy.ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.chronic lymphocytic leukaemia (cll):ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. rheumatoid arthritis:ruxience 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 polyangiitis:ruxience, 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:ruxience is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris (pv).

Unió Europea - anglès - 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).

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 10 mg/ml (murine/human monoclonal antibody);  ;  ;   - concentrate for infusion - 10 mg/ml - active: rituximab 10 mg/ml (murine/human monoclonal antibody)       excipient: citric acid hydrochloric acid polysorbate 80 sodium chloride sodium citrate dihydrate water for injection - mabthera is indicated for the treatment of patients with: · cd20 positive, previously untreated low-grade or follicular, b-cell non-hodgkin's lymphoma in combination with chemotherapy. · cd20 positive, relapsed or chemoresistant low-grade or follicular, b-cell non-hodgkin's lymphoma. · cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. mabthera is indicated for maintenance treatment of patients with cd20 positive, low grade or follicular, b-cell non-hodgkin's lymphoma.

Unió Europea - anglès - 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).

Unió Europea - anglès - 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).

Unió Europea - anglès - 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.

Unió Europea - anglès - 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).

Nova Zelanda - anglès - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - rituximab 120 mg/ml;   - solution for injection - 1400mg/11.7ml - active: rituximab 120 mg/ml   excipient: histidine histidine hydrochloride hyaluronidase methionine polysorbate 80 trehalose dihydrate water for injection - non-hodgkin's lymphoma mabthera is indicated for the treatment of patients with: · cd20 positive, previously untreated low-grade or follicular, b-cell non-hodgkin's lymphoma in combination with chemotherapy, · cd20 positive, relapsed or chemoresistant low-grade or follicular, b-cell non-hodgkin's lymphoma, · cd20 positive diffuse large b-cell non-hodgkin's lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. mabthera is indicated for maintenance treatment of patients with cd20 positive, low grade or follicular, b-cell non-hodgkin's lymphoma.