| 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 |
| Packaging [MA Number for Packaging] |
30 kapsula u blisteru, u kutiji [HR-H-600261190-01]
|
| Manufacturer |
Rontis Hellas Medical and Pharmaceutical Products S.A., Larisa, Grčka |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
18.05.2020 |
| MA Period of Validity |
18.05.2025 |
| Classification Number |
UP/I-530-09/19-01/09 |
| Registration Number |
381-12-01/38-20-10 |
| Prescription |
na recept |
| Type of prescription |
ponovljivi recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
G04CA04 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
