This is a summary of the European public assessment report (EPAR) for MabThera. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for MabThera.
MabThera : EPAR - Summary for the public (PDF/79.72 KB)
First published: 30/10/2009
Last updated: 17/06/2016
MabThera : EPAR - Risk-management-plan summary (PDF/3.64 MB)
First published: 12/07/2019
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Roche Registration GmbH
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11/03/2019 MabThera - EMEA/H/C/000165 - II/0150
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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MabThera is indicated in adults for the following indications:
MabThera is indicated for the treatment of previously untreated patients with stage-III-IV follicular lymphoma in combination with chemotherapy.
MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
MabThera 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.
MabThera 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
MabThera 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 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 antirheumatic drugs (DMARDs) 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.
MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
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