Rituzena (previously Tuxella)

Withdrawn

This medicine's authorisation has been withdrawn

rituximab

Overview

On 10 April 2019, the European Commission withdrew the marketing authorisation for Rituzena (rituximab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Celltrion Healthcare Hungary Kft., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Rituzena was granted marketing authorisation in the EU on 13 July 2017 for treatment of nonHodgkin's lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis. The marketing authorisation was initially valid for a 5-year period. 

Rituzena is a biosimilar of MabThera. There are other biosimilar medicinal products of MabThera authorised and marketed in the EU. Rituzena was a duplicate application to Truxima, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Truxima and the other duplicates Ritemvia and Blitzima. 

The European Public Assessment Report (EPAR) for Rituzena is updated to indicate that the marketing authorisation is no longer valid.

Rituzena : EPAR - Summary for the public

Reference Number: EMA/327752/2017

Product information

Rituzena : EPAR - Product Information

Rituzena : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rituzena (previously Tuxella)
• Active substance:
  rituximab
• International non-proprietary name (INN) or common name:
  rituximab
• Therapeutic area (MeSH):
  • Lymphoma, Non-Hodgkin
  • Microscopic Polyangiitis
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Wegener Granulomatosis
• Anatomical therapeutic chemical (ATC) code:
  L01XC02

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).

Authorisation details

• EMA product number:
  EMEA/H/C/004724
• Biosimilar:

  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.

• Marketing authorisation holder:
  Celltrion Healthcare Hungary Kft.

  1062 Budapest; Váci út 1-3. WestEnd Office Building B torony; Hungary

• Opinion adopted:
  18/05/2017
• Marketing authorisation issued:
  13/07/2017
• Withdrawal of marketing authorisation:
  10/04/2019
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Rituzena (previously Tuxella) : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Rituzena : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/421811/2017

CHMP summary of positive opinion for Tuxella

Adopted Reference Number: EMA/CHMP/307683/2017