Rituzena (previously Tuxella)

Withdrawn

This medicine's authorisation has been withdrawn

rituximab

Overview

The marketing authorisation for Rituzena has been withdrawn at the request of the marketing-authorisation holder.

Rituzena : EPAR - Summary for the public

Reference Number: EMA/327752/2017

Product information

Rituzena : EPAR - Product Information

Latest procedure affecting product information: IG/1053/G

28/01/2019

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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

AdoptedReference Number: EMA/CHMP/421811/2017

CHMP summary of positive opinion for Tuxella

AdoptedReference Number: EMA/CHMP/307683/2017