FULVESTRANT SANDOZ (Sandoz Pty Ltd)
Product name
FULVESTRANT SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
104 working days (255)
Active ingredients
fulvestrant
Registration type
New generic medicine
Indication
FULVESTRANT SANDOZ (solution for injection) is indicated for the treatment of postmenopausal women with hormone-receptor positive, locally advanced or metastatic breast cancer who have progressive disease following prior tamoxifen therapy.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine