Name |
Niksol 8 mg tvrde kapsule |
Marketing Authorisation Number |
HR-H-883441862 |
Active Substance |
silodozin |
Composition |
jedna tvrda kapsula sadrži 8 mg silodozina |
Pharmaceutical Form |
kapsula, tvrda |
Packaging [MA Number for Packaging] |
30 kapsula u blisteru, u kutiji [HR-H-883441862-01]
|
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-530-09/19-01/10 |
Registration Number |
381-12-01/38-20-05 |
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 |