Is Treprostinil registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 7 valid registrations of Treprostinil, including Redunix 100 mg per 20 ml (5 mg/ml, Solution for infusion, SAR 22876.55); Redunix 50 mg per 20 ml (2.5 mg/ml, Solution for infusion, SAR 14111.50); Treprostinil Tillomed (50 mg, Solution for infusion, SAR 12700.35); Treprostinil Tillomed (200 mg, Solution for infusion, SAR 41177.80); Treprostinil Tillomed (100 mg, Solution for infusion, SAR 20588.90).

Is Treprostinil approved by the US FDA?

Drugs@FDA lists 11 application product lines for Treprostinil, including REMODULIN (Prescription); TYVASO (Prescription); TREPROSTINIL (Prescription); TREPROSTINIL (Prescription); TREPROSTINIL (Prescription).

Is Treprostinil authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Treprostinil: Trepulmix.

Are there safety signals or safety updates for Treprostinil?

US FDA: 2 entries (latest 2022-05-20).

Active substance

Treprostinil

SFDA 7
US FDA 11
EMA 3
Health Canada 4
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
Redunix 100 mg per 20 ml	5 mg/ml	Solution for infusion · Intravenous, Subcutaneous	1 Vial	SAR 22876.55	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Redunix 50 mg per 20 ml	2.5 mg/ml	Solution for infusion · Intravenous, Subcutaneous	1 Vial	SAR 14111.50	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Treprostinil Tillomed	50 mg	Solution for infusion · Intravenous use	1 Vial	SAR 12700.35	Generic · Prescription	Tillomed Laboratories Limited	Valid
Treprostinil Tillomed	200 mg	Solution for infusion · Intravenous use	1 Vial	SAR 41177.80	Generic · Prescription	Tillomed Laboratories Limited	Valid
Treprostinil Tillomed	100 mg	Solution for infusion · Intravenous use	1 Vial	SAR 20588.90	Generic · Prescription	Tillomed Laboratories Limited	Valid
Trisuva	5 mg/ml	Infusion · Intravenous, Subcutaneous	1 Vial	SAR 12537.65	Generic · Prescription	AOP Orphan Pharmaceuticals GmbH	Valid
Trisuva	10 mg/ml	Infusion · Intravenous, Subcutaneous	1 Vial	SAR 21732.70	Generic · Prescription	AOP Orphan Pharmaceuticals GmbH	Valid

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION

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

Product	Strength	Form · route	Applicant	Status	First approved
REMODULIN	1MG/ML; 2.5MG/ML; 5MG/ML; 10MG/ML; 0.4MG/ML	injectable · intravenous, subcutaneous	UNITED THERAP	Prescription	21 May 2002
TYVASO	0.6MG/ML	solution · inhalation	UNITED THERAP	Prescription	30 Jul 2009
TREPROSTINIL	1MG/ML; 2.5MG/ML; 5MG/ML; 10MG/ML	injectable · intravenous, subcutaneous	SANDOZ	Prescription	30 Nov 2017
TREPROSTINIL	1MG/ML; 2.5MG/ML; 5MG/ML; 10MG/ML	injectable · intravenous, subcutaneous	TEVA PHARMS USA	Prescription	26 Sep 2019
TREPROSTINIL	1MG/ML; 2.5MG/ML; 5MG/ML; 10MG/ML	injectable · intravenous, subcutaneous	DR REDDYS	Prescription	22 May 2020
TREPROSTINIL	1MG/ML; 2.5MG/ML; 5MG/ML; 10MG/ML	injectable · intravenous, subcutaneous	ALEMBIC GLOBAL	Prescription	11 Feb 2021
TYVASO DPI	0.016MG/INH; 0.032MG/INH; 0.048MG/INH; 0.064MG/INH; 0.08MG/INH	powder · inhalation	UNITED THERAP	Prescription	23 May 2022
YUTREPIA	EQ 0.0265MG BASE/INH; EQ 0.053MG BASE/INH; EQ 0.0795MG BASE/INH; EQ 0.106MG BASE/INH	powder · inhalation	LIQUIDIA TECH	Prescription	23 May 2025
REMODULIN	20MG/ML; 0.1MG/ML; 0.2MG/ML	injectable · intravenous, subcutaneous	UNITED THERAP	Discontinued	21 May 2002
REMODULIN	20MG/20ML (1MG/ML); 50MG/20ML (2.5MG/ML); 100MG/20ML (5MG/ML); 200MG/20ML (10MG/ML)	solution · intravenous, subcutaneous	UNITED THERAP	Discontinued	30 Jul 2018
TREPROSTINIL	1MG/ML; 2.5MG/ML; 5MG/ML; 10MG/ML	injectable · intravenous, subcutaneous	PH HEALTH	Discontinued	24 Sep 2019

EMA European Union — centrally authorised medicines

Trepulmix SciPharm Sàrl · Authorised · authorised 3 Apr 2020 · ATC B01AC21

Therapeutic indication (EMA)

Treatment of adult patients with WHO Functional Class (FC) III or IV and: inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity.

Tyvaso United Therapeutics Europe Ltd · Application withdrawn

Treprostinil SciPharm Sàrl SciPharm Sàrl · Application withdrawn · ATC B01AC21

Therapeutic indication (EMA)

Treatment of chronic thromboembolic pulmonary hypertension

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REMODULIN	02246552	1 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	UNITED THERAPEUTICS CORPORATION
REMODULIN	02246553	2.5 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	UNITED THERAPEUTICS CORPORATION
REMODULIN	02246554	5 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	UNITED THERAPEUTICS CORPORATION
REMODULIN	02246555	10 MG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	UNITED THERAPEUTICS CORPORATION

Safety signals and safety-related labeling changes

US FDA 20 May 2022 TYVASO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Jul 2018 REMODULIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for treprostinil →

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.