Rituximab

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 arthritis MabThera 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 polyangiitis MabThera, 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 vulgaris MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

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 arthritis Truxima 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 polyangiitis Truxima, 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 vulgaris Truxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

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 arthritis Rixathon 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 polyangiitis Rixathon, 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 vulgaris Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

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 arthritis Riximyo 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 polyangiitis Riximyo, 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 vulgaris Riximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

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.

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 arthritis Ruxience 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 polyangiitis Ruxience, 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 vulgaris Ruxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Treatment of Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL) and rheumatoid arthritis

Treatment of Non-Hodgkin's lymphoma (NHL), Chronic lymphocytic leukaemia (CLL).

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 polyangiitis Rituzena, 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).

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).