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.
Ritemvia : EPAR - Summary for the public (PDF/90.17 KB)
First published: 15/08/2017
Last updated: 15/08/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
Celltrion Healthcare Hungary Kft.
|Date of issue of marketing authorisation valid throughout the European Union||
17/05/2018 Ritemvia - EMEA/H/C/004725 - WS/1378
- 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.
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).