5 authorised products containing Tapentadol maleate hemihydrate, from the HPRA register.
| Medicine | Active substance | Licence holder | Status |
|---|---|---|---|
| Apeneta 100 mg prolonged-release tablets PA1347/105/002 |
Tapentadol maleate hemihydrate | KRKA, d.d., Novo mesto | Marketed |
| Apeneta 150 mg prolonged-release tablets PA1347/105/003 |
Tapentadol maleate hemihydrate | KRKA, d.d., Novo mesto | Marketed |
| Apeneta 200 mg prolonged-release tablets PA1347/105/004 |
Tapentadol maleate hemihydrate | KRKA, d.d., Novo mesto | Marketed |
| Apeneta 250 mg prolonged-release tablets PA1347/105/005 |
Tapentadol maleate hemihydrate | KRKA, d.d., Novo mesto | Marketed |
| Apeneta 50 mg prolonged-release tablets PA1347/105/001 |
Tapentadol maleate hemihydrate | KRKA, d.d., Novo mesto | Marketed |
Priya Life Science (2026). Irish Medicines Database. Available at: https://priyalifescience.com/medicines (Accessed: 6 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.