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MSN-NILOTINIB (Seed Pharma Pty Ltd)

Product name
MSN-NILOTINIB
Sponsor
Seed Pharma Pty Ltd
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.