Country-specific regulatory approval and labelling for pulmonary arterial hypertension (PAH)-specific drug therapy
| Treatment | Country | Labelling | |
| Aetiology | WHO-FC | ||
| Calcium channel blockers | – | – | – |
| Ambrisentan | USA, Canada | PAH | II–III–IV |
| European Union | PAH | II–III | |
| Bosentan# | European Union | PAH | II–III |
| USA, Canada | PAH | II–III–IV | |
| Sitaxentan | European Union | PAH | III |
| Sildenafil | USA, Canada | PAH | II–III–IV |
| European Union | PAH | II–III | |
| Tadalafil¶ | USA | PAH | II–III–IV |
| Beraprost | Japan, Korea | PAH | II–III–IV |
| Epoprostenol (intravenous) | Europe+ | PAH | III–IV |
| USA, Canada | IPAH and PAH–CTD | III–IV | |
| Iloprost (inhaled) | European Union | IPAH | III |
| USA | PAH | III–IV | |
| Iloprost (intravenous) | New Zealand | IPAH, PAH–CTD and CTEPH | III–IV |
| Treprostinil (subcutaneous) | USA | PAH | II–III–IV |
| Canada | PAH | III–IV | |
| European Union§ | IPAH | III | |
| Treprostinil (intravenous) | USAƒ | PAH | II–III–IV |
| Canada | PAH | III–IV | |
| Treprostinil (inhaled)¶ | USA | PAH | III |
WHO-FC: World Health Organization functional class; IPAH: idiopathic PAH; CTD: connective tissue disease; CTEPH: chronic thromboembolic pulmonary hypertension. #: specifically approved also for PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology; ¶: under regulatory review in the European Union; +: epoprostenol in Europe has not been registered through the centralised procedure of the European Medicines Agency (EMEA) but it is approved in different European countries on a national basis; §: treprostinil in Europe has not been registered through the centralised procedure of the EMEA but it is approved in France and in other countries through the mutual recognition process on a national basis; ƒ: in the case of intolerance of the subcutaneous form.