Niksol 8 mg tvrde kapsule
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 |
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 |