MSN-NILOTINIB (Seed Pharma Pty Ltd)
Product name
MSN-NILOTINIB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
nilotinib hydrochloride sesquihydrate
Registration type
New generic medicine
Indication
[TRADE NAME] 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.