US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| ORENITRAM | EQ 0.125MG BASE; EQ 0.25MG BASE; EQ 1MG BASE; EQ 2.5MG BASE; EQ 5MG BASE | tablet, extended release · oral | UNITED THERAP | Prescription | 20 Dec 2013 |
EMA European Union — centrally authorised medicines
Orepaxam Ferrer Internacional S.A. · Application withdrawn · ATC B01AC21
Therapeutic indication (EMA)
Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominantly patients with WHO functional class II-III symptoms and aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1). Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1).
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.