BENDAMUSTINE GEN, BENDAMUSTINE JUNO, BENDAMUSTINE LU (Luminarie Pty Ltd)
Product name
BENDAMUSTINE GEN, BENDAMUSTINE JUNO, BENDAMUSTINE LU
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
136 working days (255)
Active ingredients
bendamustine hydrochloride
Registration type
New generic medicine
Indication
BENDAMUSTINE GEN, BENDAMUSTINE JUNO, BENDAMUSTINE LU (powder for injection) is indicated for:
- 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 patient's ineligible for autologous stem cell transplantation.
- Relapsed/Refractory indolent Non-Hodgkin's lymphoma.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine