Is Ribociclib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Ribociclib, including KISQALI 200 mg Film-Coated Tablet (200 mg, Film-coated tablet, SAR 8320.25).

Is Ribociclib approved by the US FDA?

Drugs@FDA lists 1 application product line for Ribociclib, including KISQALI (Prescription).

Is Ribociclib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ribociclib: Kisqali.

Are there safety signals or safety updates for Ribociclib?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2026-07-01).

Active substance

Ribociclib

SFDA 3
US FDA 1
EMA 1
Health Canada 1
US price lines 2
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
KISQALI 200 mg Film-Coated Tablet	200 mg	Film-coated tablet · Oral use	42 Blister	SAR 8320.25	NCE · Prescription	NOVARTIS PHARMA AG	Valid
KISQALI 200 mg Film-Coated Tablet	200 mg	Film-coated tablet · Oral use	63 Blister	SAR 12471.15	NCE · Prescription	NOVARTIS PHARMA AG	Valid
KISQALI 200 mg Film-Coated Tablet	200 mg	Film-coated tablet · Oral use	21 Blister	SAR 4169.40	NCE · Prescription	NOVARTIS PHARMA AG	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HORMONAL

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
KISQALI	EQ 200MG BASE	tablet · oral	NOVARTIS	Prescription	13 Mar 2017

EMA European Union — centrally authorised medicines

Kisqali Novartis Europharm Limited · Authorised · authorised 22 Aug 2017 · ATC L01EF02

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KISQALI	02473569	200 MG	TABLET · ORAL	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	KISQALI 400 MG DAILY DOSE	$346.94686	per EA	22 Jul 2026
US NADAC	KISQALI 600 MG DAILY DOSE	$289.71673	per EA	22 Apr 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 1 Jul 2026 KISQALI FEMARA CO-PACK (COPACKAGED) — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 1 Jul 2026 KISQALI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jun 2026 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2024 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: Yes
EMA PRAC 28 Sep 2023 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: No

All safety entries for ribociclib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.