PALANCE (Sun Pharma ANZ Pty Ltd)
Product name
PALANCE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
132 (255 working days)
Active ingredients
palbociclib
Registration type
New generic medicine
Indication
TRADE NAME is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy
- fulvestrant in patients who have received prior therapy.