This medicine is authorised for use in the European Union.


Ritemvia is a medicine used to treat the following blood cancers and inflammatory conditions:

  • follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of non-Hodgkin’s lymphoma, a blood cancer);
  • granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels;
  • moderate to severe pemphigus vulgaris, an autoimmune disease characterised by widespread blistering and erosion of the skin and mucous membranes (moist body surfaces, such as the lining of the mouth). ‘Autoimmune’ means that the disease is caused by the immune system (the body’s natural defences) attacking the body’s own cells.

Depending on the condition it is used to treat, Ritemvia may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids). Ritemvia contains the active substance rituximab.

Ritemvia is a ‘biosimilar medicine’. This means that Ritemvia is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Ritemvia is MabThera. For more information on biosimilar medicines, see here.

This EPAR was last updated on 11/02/2021

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Lymphoma, Non-Hodgkin
  • Microscopic Polyangiitis
  • Wegener Granulomatosis
Anatomical therapeutic chemical (ATC) code
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.


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.
Date of issue of marketing authorisation valid throughout the European Union
Contact address
1062 Budapest
Váci út 1-3. WestEnd Office Building B torony

Product information

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


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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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