Table 1.
Class of Products | Product | Authorization for Adults | Authorization for Children | ||||
---|---|---|---|---|---|---|---|
EU | United States | Canada | EU | United States | Canada | ||
Prostacyclin analogue | Treprostinil | No | Yes | Yes | No | No | No |
Selexipag | Yes | Yes | Yes | No | No | No | |
Treprostinil diethanolamine | No | Yes | No | No | No | No | |
Iloprost | Yes | Yes | No | No | No | No | |
Epoprostenol | Yes | Yes | Yes | No | No | No | |
Endothelin receptors Antagonist | Bosentan | Yes | Yes | Yes | Pharmacokinetics data | Yes | Pharmacokinetics data |
Ambrisentan | Yes | Yes | Yes | No | No | No | |
Macitentan | Yes | Yes | Yes | No | No | No | |
Phosphodiesterase type 5 inhibitor | Sildenafil | Yes | Yes | Yes | Yes | No | No |
Tadalafil | Yes | Yes | Yes | No | No | No | |
Guanylate cyclase stimulators | Riociguat | Yes | Yes | Yes | No | No | No |
Pediatric indications have not been granted; however, results of pharmacokinetic studies in the different pediatric age groups are summarized in the Summary of Product Characteristics, with a comparison to adults. Uncertainties caused by limited experience are also stated. EU indicates European Union; PAH, pulmonary arterial hypertension.