Ritemvia

Withdrawn

This medicine's authorisation has been withdrawn

rituximab

Overview

On 22 June 2021, the European Commission withdrew the marketing authorisation for Ritemvia (rituximab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Celltrion Healthcare Hungary Kft., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Ritemvia was granted marketing authorisation in the EU on 13 July 2017 for the treatment of nonHodgkin's lymphoma (NHL), granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris (PV). The marketing authorisation was initially valid for a 5-year period. 

Ritemvia is a biosimilar medicine of MabThera. There are other biosimilar medicinal products of MabThera authorised and marketed in the EU. MabThera is authorised in the EU to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris. 

Ritemvia was a duplicate of Truxima which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for another duplicate, Blitzima. 

The European Public Assessment Report (EPAR) for Ritemvia is updated to indicate that the marketing authorisation is no longer valid.

Ritemvia : EPAR - Medicine overview

Reference Number: EMA/413555/2019

Product information

Ritemvia : EPAR - Product Information

Ritemvia : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ritemvia
• 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

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).

Authorisation details

• EMA product number:
  EMEA/H/C/004725
• 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.

• Marketing authorisation holder:
  Celltrion Healthcare Hungary Kft.

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

• Opinion adopted:
  18/05/2017
• Marketing authorisation issued:
  13/07/2017
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Ritemvia : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Ritemvia : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/421799/2017

CHMP summary of positive opinion for Ritemvia

AdoptedReference Number: EMA/CHMP/307703/2017