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 |
