FULVESTRANT EVER PHARMA (Interpharma Pty Ltd)
Product name
FULVESTRANT EVER PHARMA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
132 (255 working days)
Active ingredients
fulvestrant
Registration type
New generic medicine
Indication
FULVESTRANT EVER PHARMA (solution for injection) is indicated for the treatment of postmenopausal women with:
- hormone-receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy.
- HR positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.