VELABINE (Luminarie Pty Ltd)
Product name
VELABINE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
Vinorelbine tartrate
Registration type
New generic medicine
Indication
Non-small cell lung cancer
VELABINE is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination.
Breast cancer
VELABINE is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine