Is Anifrolumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Anifrolumab, including SAPHNELO 300 mg per 2 ml (150 mg/ml, Concentrate for solution for infusion, SAR 3653.00).

Is Anifrolumab approved by the US FDA?

Drugs@FDA lists 3 application product lines for Anifrolumab, including SAPHNELO (Prescription); SAPHNELO (Prescription); SAPHNELO (Prescription).

Is Anifrolumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Anifrolumab: Saphnelo.

Are there safety signals or safety updates for Anifrolumab?

US FDA: 1 entry (latest 2026-08-07).

Active substance

Anifrolumab

SFDA 1
US FDA 3
EMA 1
Health Canada 2
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
SAPHNELO 300 mg per 2 ml	150 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 3653.00	Biological · Prescription	AstraZeneca AB	Valid

Indications — CHI Daman Drug Formulary

SYSTEMIC LUPUS ERYTHEMATOSUS

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

Product	Strength	Form · route	Applicant	Status	First approved
SAPHNELO	300MG/2ML(150MG/ML)	injectable · injection	ASTRAZENECA AB	Prescription	30 Jul 2021
SAPHNELO	300MG/2ML (150MG/ML	vial · single-use	ASTRAZENECA AB	Prescription	24 Apr 2026
SAPHNELO	120MG/0.8ML	injection	ASTRAZENECA AB	Prescription	24 Apr 2026

EMA European Union — centrally authorised medicines

Saphnelo AstraZeneca AB · Authorised · authorised 14 Feb 2022 · ATC L04AG11

Therapeutic indication (EMA)

Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SAPHNELO	02522845	150 MG / ML	SOLUTION · INTRAVENOUS	ASTRAZENECA CANADA INC
SAPHNELO	02566338	120 MG / 0.8 ML	SOLUTION · SUBCUTANEOUS	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 7 Aug 2026 SAPHNELO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for anifrolumab →

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.