| Name |
Niksol 4 mg tvrde kapsule |
| Marketing Authorisation Number |
HR-H-600261190 |
| Active Substance |
silodozin |
| Composition |
jedna tvrda kapsula sadrži 4 mg silodozina |
| Pharmaceutical Form |
kapsula, tvrda |
| Manufacturer |
Rontis Hellas Medical and Pharmaceutical Products S.A., Larissa, Grčka |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
19.05.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/118 |
| Registration Number |
381-12-01/171-25-05 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
G04CA04 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
