Ritemvia

Withdrawn

This medicine's authorisation has been withdrawn

rituximab

Overview

The marketing authorisation for Ritemvia has been withdrawn at the request of the marketing-authorisation holder.

Ritemvia : EPAR - Medicine overview

Reference Number: EMA/413555/2019

Product information

Ritemvia : EPAR - Product Information

Latest procedure affecting product information: WS/1859/G

09/10/2020

This medicine’s product information is available in all official EU languages.
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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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