Approval information
Treatment of stage III–IV follicular lymphoma
(i) as monotherapy in patients who are chemoresistant or in second subsequent relapse after chemotherapy,
(ii) in combination with chemotherapy in previously untreated patients and
(iii) as maintenance therapy in patients with relapsed or refractory disease. MabThera is also approved for first-line treatment of CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma in combination with CHOP and first-line treatment of patients with chronic lymphocytic leukaemia in combination with chemotherapy.
The European Summary of Product Characteristics (ESPC) provides comprehensive clinical, pharmacological and prescribing information about MabThera. Detailed information about the safety experience with MabThera can be found in the ESPC.
The Brief Prescribing Information document details the indications and usage of MabThera, together with a brief summary of the clinical, pharmacological and safety information.
