Is Palivizumab 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 Palivizumab, including SYNAGIS 100MG\ML I.M Solution for Injection (100 mg/ml, Solution for injection, SAR 3679.90).

Is Palivizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Palivizumab, including SYNAGIS (Prescription).

Is Palivizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Palivizumab: Synagis.

Are there safety signals or safety updates for Palivizumab?

US FDA: 1 entry (latest 2017-05-12).

Active substance

Palivizumab

SFDA 2
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
SYNAGIS 100MG\ML I.M Solution for Injection	100 mg/ml	Solution for injection · Intramuscular use	1 Vial	SAR 3679.90	Biological · Prescription	AstraZeneca AB	Valid
SYNAGIS 100MG\ML I.M VIAL	100 mg/ml	Injection · Intramuscular use	1 Vial	SAR 3472.95	Biological · Prescription	Abbvie Limited	Withdrawn by MAH · Not Marketed

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
SYNAGIS	100MG/VIAL; 50MG/VIAL	vial	SWEDISH ORPHAN	Prescription	19 Jun 1998

EMA European Union — centrally authorised medicines

Synagis AstraZeneca AB · Authorised · authorised 13 Aug 1999 · ATC J06BD01

Therapeutic indication (EMA)

Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season; children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months; children less than two years of age and with haemodynamically significant congenital heart disease.

Safety signals and safety-related labeling changes

US FDA 12 May 2017 SYNAGIS — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for palivizumab →

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.