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Ribokis 200 mg (Ribociclib)

This reference hub prioritizes regulatory agencies, official prescribing information and peer-reviewed clinical evidence.

Regulatory Sources

U.S. Food and Drug Administration — KISQALI

The FDA prescribing information provides current U.S. indications, dosing, warnings, interactions, pharmacology and clinical information.

DailyMed — KISQALI

DailyMed provides the current U.S. labeling record, including the July 2026 revision.

European Medicines Agency — Kisqali EPAR

The EMA provides European authorization, indication and product information for Kisqali.

Clinical literature

The MONALEESA program provides major clinical evidence for ribociclib in HR-positive/HER2-negative advanced or metastatic breast cancer.

Manufacturer/development information

Novartis states that Kisqali was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals.

Ribokis-specific documentation

The manufacturer, authorization status, manufacturing site and regulatory documentation for Ribokis are Everest Pharmaceuticals Ltd.