Ritemvia

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 Ritemvia. 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 Ritemvia.

For practical information about using Ritemvia, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 09/08/2018

Authorisation details

Product details
Name
Ritemvia
Agency product number
EMEA/H/C/004725
Active substance
rituximab
International non-proprietary name (INN) or common name
rituximab
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Microscopic Polyangiitis
  • Wegener Granulomatosis
Anatomical therapeutic chemical (ATC) code
L01XC02
Additional 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.

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.

Publication details
Marketing-authorisation holder
Celltrion Healthcare Hungary Kft.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
12/07/2017
Contact address
1062 Budapest
Váci út 1-3. WestEnd Office Building B torony
Hungary

Product information

17/05/2018 Ritemvia - EMEA/H/C/004725 - WS/1378

Contents

  • 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.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Ritemvia is indicated in adults for the following indications:

  • Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy.
  • Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
  • Ritemvia 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.
  • Ritemvia 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.
  • Granulomatosis with polyangiitis and microscopic polyangiitis.
  • Ritemvia, 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).

Assessment history

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