NILOTINIB-TEVA (Teva Pharma Australia Pty Ltd)
Product name
NILOTINIB-TEVA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
126 (255 working days)
Active ingredients
nilotinib hydrochloride dihydrate
Registration type
New generic medicine
Indication
NILOTINIB-TEVA is indicated for the:
- treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (CML) in chronic phase.
- treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukaemia (CML) resistant to or intolerant of prior therapy including imatinib.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine