Rituzena (previously Tuxella)



This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Rituzena has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 08/07/2019

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 monitoringAdditional 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

28/01/2019 Rituzena (previously Tuxella) - EMEA/H/C/004724 - IG/1053/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

How useful was this page?

Add your rating