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ERIBULIN SANDOZ (Sandoz Pty Ltd)
Product name
ERIBULIN SANDOZ
Sponsor
Date registered
Approval time
149 (255 working days)
Active ingredients
eribulin mesilate
Registration type
New generic medicine
Indication
ERIBULIN SANDOZ (solution for injection) is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless these are contraindicated.
ERIBULIN SANDOZ is indicated for the treatment of patients with unresectable liposarcoma who have received prior chemotherapy for advanced or metastatic disease.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine