MabThera

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rituximab

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

Overview

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.

This EPAR was last updated on 16/10/2020

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
51
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

03/09/2020 MabThera - EMEA/H/C/000165 - II/0177

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

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 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.

Pemphigus vulgaris

MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Assessment history

Changes since initial authorisation of medicine

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