This is a summary of the European public assessment report (EPAR) for Truxima. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Truxima.
For practical information about using Truxima, patients should read the package leaflet or contact their doctor or pharmacist.
Truxima : EPAR - Summary for the public (PDF/78.45 KB)
First published: 08/03/2017
Last updated: 08/03/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celltrion Healthcare Hungary Kft.
|Date of issue of marketing authorisation valid throughout the European Union||
17/05/2018 Truxima - EMEA/H/C/004112 - WS/1378
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.
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 induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).