Basic Information
Blitzima
Regulatory Information
EMEA/H/C/004723
July 13, 2017
May 18, 2017
23
May 23, 2025
Company Information
Hungary
1062 Budapest Váci út 1-3. WestEnd Office Building B torony
Celltrion Healthcare Hungary Kft
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.