SORAFENIB SANDOZ (Sandoz Pty Ltd)
Product name
SORAFENIB SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
124 (255 working days)
Active ingredients
sorafenib tosilate
Registration type
New generic medicine
Indication
Hepatocellular carcinoma
SORAFENIB SANDOZ (film coated tablet) is indicated for the treatment of patients with advanced hepatocellular carcinoma.
Renal cell carcinoma
SORAFENIB SANDOZ is indicated for the treatment of patients with advanced renal cell carcinoma.
Differentiated Thyroid carcinoma
SORAFENIB SANDOZ is indicated for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine