| Active ingredient (INN) | Bosentan |
|---|---|
| Brand names | Tracleer, Bosentan Sun |
| ATC level 5 | C02KX01 |
| ATC level 4 | C02KX |
| Therapeutic category | Auto-created by U.S. Food and Drug Administration — Drug Shortages scraper |
| Controlled substance | No |
| Marketing-authorisation holders | Janssen-Cilag Pty Ltd, Generic Health Pty Ltd, Accord Healthcare Pty Ltd, Sun Pharma ANZ Pty Ltd +1 more |
| Registrations on file | 20 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| BOSLEER Bosentan | 125 mg | — | 🇦🇺 AU | — | Active |
| TRACLEER bosentan | 62.5mg | — | 🇦🇺 AU | Janssen-Cilag Pty Ltd | Active |
| TRACLEER bosentan | 125mg | — | 🇦🇺 AU | Janssen-Cilag Pty Ltd | Active |
| Gh | 62.5 mg | — | 🇦🇺 AU | Generic Health Pty Ltd | Active |
| Genrx | 62.5mg | — | 🇦🇺 AU | — | Active |
| Genrx | 125mg | — | 🇦🇺 AU | — | Active |
| BOSLEER Bosentan | 62.5 mg | — | 🇦🇺 AU | — | Active |
| Astron | 125 mg | tabfc | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Astron | 62.5 mg | tabfc | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Intas | 62.5 mg | tabfc | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Gh | 125 mg | — | 🇦🇺 AU | Generic Health Pty Ltd | Active |
| Intas | 125 mg | tabfc | 🇦🇺 AU | Accord Healthcare Pty Ltd | Active |
| Ran | 62.5 mg | — | 🇦🇺 AU | Sun Pharma ANZ Pty Ltd | Active |
| Apo | 125 mg | — | 🇦🇺 AU | — | Active |
| Ran | 125 mg | — | 🇦🇺 AU | Sun Pharma ANZ Pty Ltd | Active |