Is Abemaciclib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Abemaciclib, including VERZENIO 100 MG FILM-COATED TABLET (100 mg, Film-coated tablet, SAR 3117.80); VERZENIO 150 MG FILM-COATED TABLET (150 mg, Film-coated tablet, SAR 3117.80); VERZENIO 200 MG FILM-COATED TABLET (200 mg, Film-coated tablet, SAR 3117.80); VERZENIO 50 MG FILM-COATED TABLET (50 mg, Film-coated tablet, SAR 3117.80).

Is Abemaciclib approved by the US FDA?

Drugs@FDA lists 2 application product lines for Abemaciclib, including VERZENIO (Prescription); VERZENIO (Prescription).

Is Abemaciclib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Abemaciclib: Verzenios.

Are there safety signals or safety updates for Abemaciclib?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2026-09-18).

Active substance

Abemaciclib

SFDA 4
US FDA 2
EMA 1
Health Canada 4
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VERZENIO 100 MG FILM-COATED TABLET	100 mg	Film-coated tablet · Oral use	14 Blister	SAR 3117.80	NCE · Prescription	Eli Lilly and Company	Valid
VERZENIO 150 MG FILM-COATED TABLET	150 mg	Film-coated tablet · Oral use	14 Blister	SAR 3117.80	NCE · Prescription	Eli Lilly and Company	Valid
VERZENIO 200 MG FILM-COATED TABLET	200 mg	Film-coated tablet · Oral use	14 Blister	SAR 3117.80	NCE · Prescription	Eli Lilly and Company	Valid
VERZENIO 50 MG FILM-COATED TABLET	50 mg	Film-coated tablet · Oral use	14 Blister	SAR 3117.80	NCE · Prescription	Eli Lilly and Company	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
VERZENIO	50MG; 100MG; 150MG; 200MG	tablet · oral	ELI LILLY AND CO	Prescription	28 Sep 2017
VERZENIO	50MG; 100MG; 150MG; 200MG	tablet · oral	ELI LILLY AND CO	Prescription	26 Feb 2018

EMA European Union — centrally authorised medicines

Verzenios Eli Lilly Nederland B.V. · Authorised · authorised 26 Sep 2018 · ATC L01EF03

Therapeutic indication (EMA)

Early Breast Cancer Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (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
VERZENIO	02487098	50 MG	TABLET · ORAL	ELI LILLY CANADA INC
VERZENIO	02487101	100 MG	TABLET · ORAL	ELI LILLY CANADA INC
VERZENIO	02487128	150 MG	TABLET · ORAL	ELI LILLY CANADA INC
VERZENIO	02487136	200 MG	TABLET · ORAL	ELI LILLY CANADA INC

Safety signals and safety-related labeling changes

US FDA 18 Sep 2026 VERZENIO — 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 abemaciclib →

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.