Is Belatacept registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Belatacept.

Is Belatacept approved by the US FDA?

Drugs@FDA lists 1 application product line for Belatacept, including NULOJIX (Prescription).

Is Belatacept authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Belatacept: Nulojix.

Are there safety signals or safety updates for Belatacept?

US FDA: 1 entry (latest 2021-07-28).

Active substance

Belatacept

SFDA 1
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NULOJIX 250 mg lyophilisate for solution for injection	250 mg	Lyophilisate for solution for injection · Intravenous use	1 Vial	SAR 2050.50	Biological · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
NULOJIX	250MG	injectable · injection	BRISTOL MYERS SQUIBB	Prescription	15 Jun 2011

EMA European Union — centrally authorised medicines

Nulojix Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 17 Jun 2011 · ATC L04AA28

Therapeutic indication (EMA)

Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.

Safety signals and safety-related labeling changes

US FDA 28 Jul 2021 NULOJIX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for belatacept →

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.