Is Nirsevimab 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 Nirsevimab, including Beyfortus (50 mg, Solution for injection, SAR 3781.75); Beyfortus 100 mg per 1 ml (100 mg/ml, Solution for injection, SAR 3781.75).

Is Nirsevimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Nirsevimab, including BEYFORTUS (Prescription).

Is Nirsevimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nirsevimab: Beyfortus.

Are there safety signals or safety updates for Nirsevimab?

US FDA: 1 entry (latest 2025-10-20).

Active substance

Nirsevimab

SFDA 2
US FDA 1
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
Beyfortus	50 mg	Solution for injection · Intramuscular use	1 Pre-filled syringe	SAR 3781.75	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid
Beyfortus 100 mg per 1 ml	100 mg/ml	Solution for injection · Intramuscular use	1 Pre-filled syringe	SAR 3781.75	Biological · Prescription	SANOFI WINTHROP INDUSTRIE	Valid

Indications — CHI Daman Drug Formulary

RESPIRATORY SYNCYTIAL VIRUS - PROPHYLACTIC IMMUNOTHERAPY

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

Product	Strength	Form · route	Applicant	Status	First approved
BEYFORTUS	50MG; 100MG	injectable · injection	ASTRAZENECA AB	Prescription	17 Jul 2023

EMA European Union — centrally authorised medicines

Beyfortus Sanofi Winthrop Industrie · Authorised · authorised 31 Oct 2022 · ATC J06BD08

Therapeutic indication (EMA)

Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations. Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:i. Neonates and infants during their first RSV season.ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1).Beyfortus should be used in accordance with official recommendations.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BEYFORTUS	02537206	50 MG / 0.5 ML	SOLUTION · INTRAMUSCULAR	SANOFI VACCINES CANADA LTD.
BEYFORTUS	02537214	100 MG / 1 ML	SOLUTION · INTRAMUSCULAR	SANOFI VACCINES CANADA LTD.

Safety signals and safety-related labeling changes

US FDA 20 Oct 2025 BEYFORTUS — 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 nirsevimab →

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.