Is Iloprost 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 Iloprost, including APRELEX 20MCG/ML INHALATION SOLUTION (20 µ/ml, inhalation solution, SAR 2132.15); VENTAVIS 10 mcg/ml solution for inhalation (10 µ/ml, Nebuliser solution, SAR 2624.15).

Is Iloprost approved by the US FDA?

Drugs@FDA lists 3 application product lines for Iloprost, including AURLUMYN (Prescription); ILOPROST (Prescription); VENTAVIS (Discontinued).

Is Iloprost authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Iloprost: Ventavis.

Are there safety signals or safety updates for Iloprost?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2019-12-16).

Active substance

Iloprost

SFDA 3
US FDA 3
EMA 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
APRELEX 20MCG/ML INHALATION SOLUTION	20 µ/ml	inhalation solution · Inhalation use	30 Ampoule	SAR 2132.15	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
VENTAVIS 10 mcg/ml solution for inhalation	10 µ/ml	Nebuliser solution · Inhalation use	30 Ampoule	SAR 2624.15	NCE · Prescription	BAYER AG	Valid
VENTAVIS 10 mcg/ml solution for inhalation	10 µ/ml	Solution · Inhalation use	30 Ampoule	SAR 3280.20	NCE · Prescription	BAYER PHARMA AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
AURLUMYN	100MCG/ML (100MCG/ML)	solution · intravenous	BTG INTL	Prescription	13 Feb 2024
ILOPROST	10MCG/ML (10MCG/ML); 20MCG/ML (20MCG/ML)	solution · inhalation	REGCON HOLDINGS	Prescription	10 Jul 2026
VENTAVIS	20MCG/2ML (10MCG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 10MCG/ML (10MCG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 20MCG/ML (20MCG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · inhalation	ACTELION	Discontinued	29 Dec 2004

EMA European Union — centrally authorised medicines

Ventavis Bayer AG · Authorised · authorised 15 Sep 2003 · ATC B01AC11

Therapeutic indication (EMA)

Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.

Safety signals and safety-related labeling changes

US FDA 16 Dec 2019 VENTAVIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2017 PRAC signal: Bradycardia
Action for MAH: update of the product information: No

All safety entries for iloprost →

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.