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NILOTINIB (Dr Reddys Laboratories Australia Pty Ltd)

Product name
NILOTINIB
Sponsor
Dr Reddys Laboratories Australia Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
119 (255 working days)
Active ingredients
Nilotinib hydrochloride monohydrate
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.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine