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Rituzena (previously Tuxella) (rituximab)

BiosimilarAdditional monitoring
Region
🇪🇺 EU
Active substance
rituximab
Company
Celltrion Healthcare Hungary Kft.
Status
Withdrawn
Therapeutic area
Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis
CHMP opinion
Thu 18 May 2017
EU approval
Thu 13 Jul 2017
Designations
Biosimilar, Additional monitoring
Application
EMEA/H/C/004724
ATC
L01XC02
Official record
www.ema.europa.eu

Indication

Rituzena is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rituzena is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Rituzena 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. Rituzena 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) Rituzena 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 Rituzenaor patients refractory to previous Rituzena plus chemotherapy. Granulomatosis with polyangiitis and microscopic polyangiitis Rituzena, 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).

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.