MabThera

RSS

rituximab

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 07/09/2018

Authorisation details

Product details
Name
MabThera
Agency product number
EMEA/H/C/000165
Active substance
rituximab
International non-proprietary name (INN) or common name
rituximab
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Arthritis, Rheumatoid
  • Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XC02
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
43
Date of issue of marketing authorisation valid throughout the European Union
02/06/1998
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

09/08/2018 MabThera - EMEA/H/C/000165 - N/0155

Contents

  • 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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

MabThera is indicated in adults for the following indications:

Non-Hodgkin's lymphoma

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.

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 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.

Assessment history

Changes since initial authorisation of medicine

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