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BENDAMUSTINE EPSL (Eugia Pharma (Australia) Pty Ltd)
Product name
BENDAMUSTINE EPSL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
130 (255 working days)
Active ingredients
bendamustine hydrochloride monohydrate
Registration type
New generic medicine
Indication
First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first-line therapies other than chlorambucil has not been established.
Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin’s lymphoma, in combination with rituximab.
Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.
Relapsed/Refractory indolent Non-Hodgkin’s lymphoma.