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KISQALI (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
KISQALI
Date registered
Evaluation commenced
Decision date
Approval time
194 working days (255)
Active ingredients
ribociclib (as succinate)
Registration type
EOI
Indication
KISQALI (film coated tablets) is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine-based therapy or following prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.