Blitzima

RSS

rituximab

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

Overview

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.

This EPAR was last updated on 14/02/2019

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
L01XC02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
6
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

28/01/2019 Blitzima - EMEA/H/C/004723 - IG/1053/G

Contents

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.

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

How useful was this page?

Add your rating