KISQALI (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
KISQALI
Date registered
Evaluation commenced
Decision date
Approval time
158 (255 working days)
Active ingredients
ribociclib succinate
Registration type
EOI
Indication
Early breast cancer
KISQALI in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.