FASLODEX (AstraZeneca Pty Ltd)
Product name
FASLODEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
173 (175 working days)
Active ingredients
fulvestrant
Registration type
EOI
Indication
FASLODEX (solution for injection) is now also 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.