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.
Ritemvia : EPAR - Medicine overview (PDF/150.01 KB) (updated)
First published: 15/08/2017
Last updated: 11/02/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Celltrion Healthcare Hungary Kft.
|Date of issue of marketing authorisation valid throughout the European Union||
09/10/2020 Ritemvia - EMEA/H/C/004725 - WS/1859/G
- 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
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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).