CIPLA PALBOCICLIB/ CIP PALBOCICLIB/ CIPALON (Cipla Australia Pty Ltd)
Product name
CIPLA PALBOCICLIB/ CIP PALBOCICLIB/ CIPALON
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
136 (255 working days)
Active ingredients
palbociclib
Registration type
New generic medicine
Indication
CIP PALBOCICLIB 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
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine