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 Pharmaceticals Hellas S.A., Kamatero, Athena, Grčka IASIS Pharmaceticals Hellas S.A., Koropi Attikis, Grčka |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 02.11.2022 |
| MA Period of Validity | 10.06.2026 |
| Classification Number | UP/I-530-09/19-01/195 |
| Registration Number | 381-12-01/154-22-14 |
| Prescription | na recept |
| Type of prescription | neponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J01XE51 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
