Prevuro 50 mg tvrde kapsule
| Name | Prevuro 50 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-734453642 |
| Active Substance | nitrofurantoin |
| Composition | svaka kapsula sadrži 50 mg nitrofurantoina (u makrokristalnom obliku). |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | IASIS Pharmaceuticals Hellas S.A., Kamatero, Athena, Grčka IASIS Pharmaceuticals Hellas S.A., Koropi Attikis, Grčka |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 26.05.2026 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/25-02/126 |
| Registration Number | 381-12-01/286-26-08 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for non-renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J01XE01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
