Ritemvia

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rituximab

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ritemvia has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 16/08/2021

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 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
8
Date of issue of marketing authorisation valid throughout the European Union
13/07/2017
Contact address

1062 Budapest
Váci út 1-3. WestEnd Office Building B torony
Hungary

Product information

09/10/2020 Ritemvia - EMEA/H/C/004725 - WS/1859/G

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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