Is Abrocitinib 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 Abrocitinib, including CIBINQO (50 mg, Film-coated tablet, SAR 3901.20); CIBINQO (100 mg, Film-coated tablet, SAR 3901.20); CIBINQO (200 mg, Film-coated tablet, SAR 3901.20).

Is Abrocitinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Abrocitinib, including CIBINQO (Prescription).

Is Abrocitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Abrocitinib: Cibinqo.

Active substance

Abrocitinib

SFDA 3
US FDA 1
EMA 1
Health Canada 3
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CIBINQO	50 mg	Film-coated tablet · Oral use	30 Bottle	SAR 3901.20	NCE · Prescription	Pfizer Limited	Valid
CIBINQO	100 mg	Film-coated tablet · Oral use	30 Bottle	SAR 3901.20	NCE · Prescription	Pfizer Limited	Valid
CIBINQO	200 mg	Film-coated tablet · Oral use	30 Bottle	SAR 3901.20	NCE · Prescription	Pfizer Limited	Valid

Indications — CHI Daman Drug Formulary

ECZEMA

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

Product	Strength	Form · route	Applicant	Status	First approved
CIBINQO	50MG; 100MG; 200MG	tablet · oral	PFIZER	Prescription	14 Jan 2022

EMA European Union — centrally authorised medicines

Cibinqo Pfizer Europe MA EEIG · Authorised · authorised 9 Dec 2021 · ATC D11AH08

Therapeutic indication (EMA)

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CIBINQO	02528363	50 MG	TABLET · ORAL	PFIZER CANADA ULC
CIBINQO	02528371	100 MG	TABLET · ORAL	PFIZER CANADA ULC
CIBINQO	02528398	200 MG	TABLET · ORAL	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CIBINQO 100 MG TABLET	$197.09241	per EA	23 Sep 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.

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.