Kisqali
Kisqali ingredients
| Active ingredient | Strength |
|---|---|
| Ribociclib Succinate | 200 mg/1 |
What Kisqali is used for
The FDA lists the approved uses on the official label (below). In the EU, ribociclib is approved as Kisqali for:
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 early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Kisqali
- Generic name
- Ribociclib
- Made by
- Novartis Pharmaceuticals Corporation
- Forms
- Tablet, Film Coated
- Given
- Oral
- Drug class
- Kinase Inhibitor
- FDA approval
- New drug application (NDA) NDA209092
- On the US market since
- 2017
Official information
- Kisqali prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Ribociclib)
In India
- Ribociclib succinate: 1 brand in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Kisqali?
Kisqali (Ribociclib) is a cancer medicine made by Novartis Pharmaceuticals Corporation, approved by the US FDA.
What are the ingredients of Kisqali?
Kisqali contains Ribociclib Succinate (200 mg/1).
Is Kisqali approved in Europe?
The same active substance is approved in the EU as Kisqali.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA