BENDAMUSTINE MYLAN (Alphapharm Pty Ltd)

Product name

BENDAMUSTINE MYLAN

Date registered

7 December 2020

Evaluation commenced

30 August 2019

Decision date

12 June 2020

Approval time

149 working days (225)

Active ingredients

bendamustine hydrochloride

Registration type

New generic medicine

Indication

BENDAMUSTINE MYLAN 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 patients 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