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FULVESTRANT ANS (Southern XP IP Pty Ltd)
Product name
FULVESTRANT ANS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
117 (255 working days)
Active ingredients
fulvestrant
Registration type
New generic medicine
Indication
FULVESTRANT ANS 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.