6 authorised products containing Bosentan monohydrate, from the HPRA register.
| Medicine | Active substance | Licence holder | Status |
|---|---|---|---|
| Bosentan Accord 125 mg film-coated tablets PA2315/286/002 |
Bosentan monohydrate | Accord Healthcare Ireland Ltd. | Not marketed |
| Bosentan Accord 62.5 mg film-coated tablets PA2315/286/001 |
Bosentan monohydrate | Accord Healthcare Ireland Ltd. | Not marketed |
| Bosentan Zentiva 125 mg film-coated tablets PA1701/011/002 |
Bosentan monohydrate | Zentiva k.s. | Not marketed |
| Bosentan Zentiva 62.5 mg film-coated tablets PA1701/011/001 |
Bosentan monohydrate | Zentiva k.s. | Not marketed |
| STAYVEER 125 mg film-coated tablets EU/1/13/832/002 |
Bosentan monohydrate | Janssen Pharmaceutica NV | — |
| STAYVEER 62.5 mg film-coated tablets EU/1/13/832/001 |
Bosentan monohydrate | Janssen Pharmaceutica NV | — |
Priya Life Science (2026). Irish Medicines Database. Available at: https://priyalifescience.com/medicines (Accessed: 5 July 2026).
Data: Health Products Regulatory Authority (HPRA) open dataset (“Authorised or Transfer Pending Products”), licensed CC BY 4.0, refreshed daily. Regulatory information only — not medical advice.