Skip to main content

RITEMVIA, TRUXIMA (Pharmbio Pty Ltd)

Product name
RITEMVIA, TRUXIMA
Date registered
Evaluation commenced
Decision date
Approval time
199 working days (255)
Active ingredients
rituximab
Registration type
New biosimilar medicine
Indication

RITEMVIA, TRUXIMA are indicated for the treatment of:

Non-Hodgkin's Lymphoma

RITEMVIA, TRUXIMA are indicated for treatment of patients with:

  • CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin's lymphoma
  • CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma
  • CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy
Chronic Lymphocytic Leukaemia

RITEMVIA, TRUXIMA are indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.

Rheumatoid Arthritis

RITEMVIA, TRUXIMA, in combination with methotrexate, are indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF)inhibitor therapy.

Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA)

RITEMVIA,TRUXIMA, in combination with glucocorticoids, are indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with rituximab have not been established.

Help us improve the Therapeutic Goods Administration site