Dronedaron Pliva 400 mg filmom obložene tablete
Name | Dronedaron Pliva 400 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-559001091 |
Active Substance | dronedaronklorid |
Composition | jedna tableta sadrži 400 mg dronedarona (u obliku dronedaronklorida) |
Pharmaceutical Form | filmom obložena tableta |
Manufacturer | Rontis Hellas Medical and Pharmaceutical Products S.A., Larisa, Grčka |
Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
Marketing Authorisation Date | 15.09.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/23-02/54 |
Registration Number | 381-12-01/154-23-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C01BD07 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Educational materials for healthcare professionals |
Vodič za propisivače, verzija 1 |