| Medicine | Active substance | Licence holder | Status |
| Tradol 50mg/ml Solution for Injection or Infusion PA0711/029/003 |
Tramadol hydrochloride |
Rowex Limited, |
Not marketed |
| Tradol SR 100 mg Prolonged release tablets PA0711/029/005 |
Tramadol hydrochloride |
Rowex Limited, |
Marketed |
| Tradol SR 150 mg Prolonged release tablets PA0711/029/006 |
Tramadol hydrochloride |
Rowex Limited, |
Marketed |
| Tradol SR 200 mg Prolonged release tablets PA0711/029/007 |
Tramadol hydrochloride |
Rowex Limited, |
Marketed |
| Ulipristal Acetate Rowex 30 mg film-coated tablets PA0711/292/001 |
Ulipristal acetate |
Rowex Limited, |
Marketed |
| Valotix 500mg film-coated tablets PA0711/173/001 |
Valaciclovir hydrochloride |
Rowex Limited, |
Marketed |
| Vatan 160 mg Film-coated Tablets PA0711/183/003 |
Valsartan |
Rowex Limited, |
Marketed |
| Vatan 40 mg Film-coated Tablets PA0711/183/001 |
Valsartan |
Rowex Limited, |
Marketed |
| Vatan 80 mg Film-coated Tablets PA0711/183/002 |
Valsartan |
Rowex Limited, |
Marketed |
| Verap 120mg Prolonged Release Tablets PA0711/016/004 |
Verapamil hydrochloride |
Rowex Limited, |
Marketed |
| Verap 240mg prolonged release tablets PA0711/016/005 |
Verapamil hydrochloride |
Rowex Limited, |
Marketed |
| Zofran 4 mg film-coated tablets PA0711/327/003 |
Ondansetron |
Rowex Limited, |
Marketed |
| Zofran 4mg/2ml Solution for Injection or Infusion PA0711/327/001 |
Ondansetron hydrochloride dihydrate |
Rowex Limited, |
Marketed |
| Zofran 8 mg film-coated tablets PA0711/327/004 |
Ondansetron |
Rowex Limited, |
Marketed |
| Zofran Zydis 4 mg oral lyophilisate PA0711/327/005 |
Ondansetron |
Rowex Limited, |
Marketed |
| Zofran Zydis 8 mg oral lyophilisate PA0711/327/006 |
Ondansetron |
Rowex Limited, |
Marketed |
| Zolnod 10 mg film-coated tablets PA0711/039/001 |
Zolpidem tartrate |
Rowex Limited, |
Marketed |
| Zonisamide Rowex 100 mg hard capsules PA0711/336/003 |
Zonisamide |
Rowex Limited, |
Not marketed |
| Zonisamide Rowex 25 mg hard capsules PA0711/336/001 |
Zonisamide |
Rowex Limited, |
Not marketed |
| Zonisamide Rowex 50 mg hard capsules PA0711/336/002 |
Zonisamide |
Rowex Limited, |
Not marketed |
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.