SUNITINIB SANDOZ (Sandoz Pty Ltd)
Product name
SUNITINIB SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
164 working days (175)
Active ingredients
sunitinib
Registration type
New generic medicine
Indication
SUNITINIB SANDOZ (capsule) is indicated for:
- treatment of advanced renal cell carcinoma (RCC),
- treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance,
- treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine