This medicine is authorised for use in the European Union.


Ruxience 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);

• chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);

• severe rheumatoid arthritis (an inflammatory condition of the joints);

• granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels;

• pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.

Depending on the condition it is used to treat, Ruxience may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).

Ruxience contains the active substance rituximab.

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

This EPAR was last updated on 29/11/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Arthritis, Rheumatoid
  • Microscopic Polyangiitis
  • Pemphigus
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
Pfizer Europe MA EEIG 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles

Product information

23/08/2023 Ruxience - EMEA/H/C/004696 - PSUSA/00002652/202211

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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

Ruxience is indicated in adults for the following indications:

Non‑Hodgkin’s lymphoma (NHL)

Ruxience is indicated for the treatment of previously untreated patients with stage III‑IV follicular lymphoma in combination with chemotherapy.

Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

Ruxience monotherapy is indicated for treatment of patients with stage III‑IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.

Ruxience 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.

Chronic lymphocytic leukaemia (CLL)

Ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.

Rheumatoid arthritis

Ruxience in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease‑modifying anti‑rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.

Ruxience has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function, when given in combination with methotrexate.

Granulomatosis with polyangiitis and microscopic polyangiitis

Ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

Pemphigus vulgaris

Ruxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Assessment history

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