Is Beractant 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 Beractant, including SURVANTA INTRATRACHEAL SUSP.VIAL 8ML (25 mg/ml, Endotracheopulmonary instillation, suspension, SAR 1742.40).

Is Beractant approved by the US FDA?

Drugs@FDA lists 1 application product line for Beractant, including SURVANTA (Prescription).

Is Beractant on the WHO Model List of Essential Medicines?

Yes — 22.7. Medicines administered to the neonate [c] (complementary list): Respiratory distress syndrome of newborn.

Active substance

Beractant

SFDA 1
US FDA 1
Health Canada 1
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SURVANTA INTRATRACHEAL SUSP.VIAL 8ML	25 mg/ml	Endotracheopulmonary instillation, suspension · Intratracheal use	1 Vial	SAR 1742.40	NCE · Prescription	ABBVIE Inc.	Valid

Indications — CHI Daman Drug Formulary

NEONATAL RESPIRATORY DISTRESS SYNDROME (NRDS)

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

Product	Strength	Form · route	Applicant	Status	First approved
SURVANTA	25MG/ML	suspension · intratracheal	ABBVIE	Prescription	1 Jul 1991

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SURVANTA	02016109	25 MG / ML	SUSPENSION · INTRATRACHEAL	ABBVIE CORPORATION

WHO WHO Model List of Essential Medicines (2025)

22.7. Medicines administered to the neonate [c] · complementary
Respiratory distress syndrome of newborn
Respiratory > Suspension: 25 mg per mL for intratracheal instillation (EMLc)

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.