FULVESTRANT EUGIA/ EUG-FULVESTRANT/ FULVESTRANT EPSL (Eugia Pharma (Australia) Pty Ltd)
Product name
FULVESTRANT EUGIA/ EUG-FULVESTRANT/ FULVESTRANT EPSL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
fulvestrant
Registration type
New generic medicine
Indication
EUG-FULVESTRANT/ FULVESTRANT EPSL/ FULVESTRANT EUGIA 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.