Blitzima

RSS

rituximab

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

Overview

Blitzima 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);
  • granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels;
  • moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (moist body surfaces, such as the lining of the mouth). ‘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, Blitzima may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids). Blitzima contains the active substance rituximab.

Blitzima is a ‘biosimilar medicine’. This means that Blitzima is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Blitzima is MabThera. For more information on biosimilar medicines, see below.

This EPAR was last updated on 30/11/2022

Authorisation details

Product details
Name
Blitzima
Agency product number
EMEA/H/C/004723
Active substance
rituximab
International non-proprietary name (INN) or common name
rituximab
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell
Anatomical therapeutic chemical (ATC) code
L01FA01
BiosimilarBiosimilar

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.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
13/07/2017
Contact address

Váci út 1-3. West End Office
Building B torony
1062 Budapest
Hungary

Product information

10/11/2022 Blitzima - EMEA/H/C/004723 - N/0061

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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

Blitzima is indicated in adults for the following indications:

Non-Hodgkin’s lymphoma (NHL)

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

Blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Blitzima 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.

Blitzima 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)

Blitzima 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 Blitzima or patients refractory to previous Blitzima plus chemotherapy.

Assessment history

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