Nitrofurantoin Galenika 50 mg tvrde kapsule
| Name | Nitrofurantoin Galenika 50 mg tvrde kapsule |
|---|---|
| Former Name | Nitrofurantoin PharmSol 50 mg tvrde kapsule |
| Marketing Authorisation Number | HR-H-523618855 |
| Active Substance | nitrofurantoin |
| Composition | jedna kapsula sadrži 50 mg nitrofurantoina (u makrokristalnom obliku) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | PharmSol Europe Limited, Paola, Malta Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder | Galenika International Kft., Baross utca 165/3, Budaörs, Mađarska |
| Marketing Authorisation Date | 03.11.2025 |
| MA Period of Validity | 24.06.2029 |
| Classification Number | UP/I-530-09/22-01/11 |
| Registration Number | 381-12-01/70-25-38 |
| 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 | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
