MabThera is a medicine used to treat the following blood cancers and inflammatory conditions:
- follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of non-Hodgkin’s lymphoma, a blood cancer);
- chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);
- severe rheumatoid arthritis (an inflammatory condition of the joints);
- two inflammatory conditions of blood vessels known as granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA);
- moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (the linings of internal organs). ‘Autoimmune’ means that the disease is caused by the immune system (the body’s natural defences) attacking the body’s own cells.
Depending on the condition it is used to treat, MabThera may be given on its own, or with chemotherapy, methotrexate or a corticosteroid.
MabThera contains the active substance rituximab.
MabThera : EPAR - Medicine overview (PDF/151.7 KB)
First published: 30/10/2009
Last updated: 11/12/2020
MabThera : EPAR - Risk-management-plan summary (PDF/316.34 KB)
First published: 12/07/2019
Last updated: 30/05/2023
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Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
16/08/2023 MabThera - EMEA/H/C/000165 - PSUSA/00002652/202211
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Product information documents contain:
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- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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.
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.
MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 202031/01/2020
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 January 201901/02/2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 201816/11/2018
European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection19/11/2013
European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations23/10/2012