Is Abatacept registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Abatacept, including ORENCIA 125MG Solution for injection in pre-filled syringe (125 mg, Solution for injection, SAR 4501.50); ORENCIA 250MG POWDER FOR SOLUTION FOR INFUSION (250 mg, Powder for solution for infusion, SAR 1124.15).

Is Abatacept approved by the US FDA?

Drugs@FDA lists 1 application product line for Abatacept, including ORENCIA (Prescription).

Is Abatacept authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Abatacept: Orencia.

Are there safety signals or safety updates for Abatacept?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2024-01-19).

Active substance

Abatacept

SFDA 2
US FDA 1
EMA 1
Health Canada 2
US price lines 1
NHS prices 1
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
ORENCIA 125MG Solution for injection in pre-filled syringe	125 mg	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 4501.50	NCE · Prescription	BRISTOL-MYERS SQUIBB	Valid
ORENCIA 250MG POWDER FOR SOLUTION FOR INFUSION	250 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 1124.15	NCE · Prescription	BRISTOL-MYERS SQUIBB	Valid

Indications — CHI Daman Drug Formulary

JUVENILE POLYARTHRITIS; NON-INFECTIOUS UVEITIS; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS; SJOGREN'S SYNDROME; SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
ORENCIA	250MG	injectable · iv (infusion)	BRISTOL MYERS SQUIBB	Prescription	23 Dec 2005

EMA European Union — centrally authorised medicines

Orencia Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 21 May 2007 · ATC L04AA24

Therapeutic indication (EMA)

Rheumatoid arthritis Orencia, in combination with methotrexate, is indicated for: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis Orencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. Polyarticular juvenile idiopathic arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy. Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ORENCIA	02282097	250 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	BRISTOL-MYERS SQUIBB CANADA
ORENCIA	02402475	125 MG / ML	SOLUTION · SUBCUTANEOUS	BRISTOL-MYERS SQUIBB CANADA

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ORENCIA 125 MG/ML SYRINGE	$1469.228	per ML	23 Sep 2026
NHS Drug Tariff	Abatacept 125mg/1ml solution for injection pre-filled disposable devices	£1209.60	4 pre-filled disposable injection	1 Oct 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 19 Jan 2024 ORENCIA — 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 7 Apr 2022 PRAC signal: Acute respiratory distress syndrome (ARDS)
Action for MAH: update of the product information: No
EMA PRAC 2 Dec 2021 PRAC signal: Acute respiratory distress syndrome (ARDS)
Action for MAH: update of the product information: No
EMA PRAC 9 Jan 2014 PRAC signal: Angioedema
Action for MAH: update of the product information: No

All safety entries for abatacept →

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.