Ruxience (rituximab)
- Region
- 🇪🇺 EU
- Active substance
- rituximab
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Wed 01 Apr 2020
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004696
- ATC
- L01XC02
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Ituxredi Authorised · Reddy Holding GmbH
- 🇪🇺 Ritemvia Withdrawn · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Rituximab Mabion Application withdrawn · Mabion Spolka Akcyjna
- 🇪🇺 Rituzena (previously Tuxella) Withdrawn · Celltrion Healthcare Hungary Kft.
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