Rituzena (previously Tuxella)



This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Rituzena. 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 Rituzena.

For practical information about using Rituzena, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Rituzena (previously Tuxella)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Microscopic Polyangiitis
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Wegener Granulomatosis
Anatomical therapeutic chemical (ATC) code
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Celltrion Healthcare Hungary Kft.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
1062 Budapest
Váci út 1-3. WestEnd Office Building B torony

Product information

19/07/2018 Rituzena (previously Tuxella) - EMEA/H/C/004724 - 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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Rituzena is indicated in adults for the following indications:

Non-Hodgkin’s lymphoma (NHL)

Rituzena is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy.

Rituzena 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.

Rituzena 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)

Rituzena 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 Rituzenaor patients refractory to previous Rituzena plus chemotherapy.

Granulomatosis with polyangiitis and microscopic polyangiitis

Rituzena, 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).

Assessment history

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