This is a summary of the European public assessment report (EPAR) for Blitzima. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Blitzima.
For practical information about using Blitzima, patients should read the package leaflet or contact their doctor or pharmacist.
Blitzima : EPAR - Summary for the public (PDF/84.07 KB)
First published: 17/08/2017
Last updated: 17/08/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celltrion Healthcare Hungary Kft.
|Date of issue of marketing authorisation valid throughout the European Union||
28/01/2019 Blitzima - EMEA/H/C/004723 - IG/1053/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.