Active substance
Epoprostenol
- US FDA 6
- Health Canada 4
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| VELETRI | EQ 1.5MG BASE/VIAL; EQ 0.5MG BASE/VIAL | injectable · injection | ACTELION | Prescription | 27 Jun 2008 |
| EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL; EQ 1.5MG BASE/VIAL | injectable · injection | SUN PHARM | Prescription | 15 Jan 2021 |
| EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL; EQ 1.5MG BASE/VIAL | injectable · injection | MYLAN | Prescription | 12 Jun 2024 |
| EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL; EQ 1.5MG BASE/VIAL | injectable · injection | GLAND | Prescription | 29 Dec 2025 |
| FLOLAN | EQ 0.5MG BASE/VIAL; EQ 1.5MG BASE/VIAL | injectable · injection | GLAXOSMITHKLINE LLC | Discontinued | 20 Sep 1995 |
| EPOPROSTENOL SODIUM | EQ 0.5MG BASE/VIAL; EQ 1.5MG BASE/VIAL | injectable · injection | MEITHEAL | Discontinued | 23 Apr 2008 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CARIPUL | 02397447 | 0.5 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | JANSSEN INC |
| CARIPUL | 02397455 | 1.5 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | JANSSEN INC |
| FLOLAN | 02230845 | 0.5 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | GLAXOSMITHKLINE INC |
| FLOLAN | 02230848 | 1.5 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | GLAXOSMITHKLINE INC |
Safety signals and safety-related labeling changes
- US FDA 24 Aug 2021 FLOLAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Oct 2020 VELETRI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
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.