Ursosan 500 mg filmom obložene tablete
| Name | Ursosan 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-394260635 |
| Active Substance | ursodeoksikolatna kiselina |
| Composition | svaka filmom obložena tableta sadrži 500 mg ursodeoksikolatne kiseline |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Pro.Med.Cs. Praha a.s., Prague 4, Češka |
| Marketing Authorisation Holder | Kappler Pharma Consult GmbH, Fonyoder Straße 18, Leipheim, Njemačka |
| Marketing Authorisation Date | 05.01.2022 |
| MA Period of Validity | 05.01.2027 |
| Classification Number | UP/I-530-09/20-01/125 |
| Registration Number | 381-12-01/154-22-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | A05AA02 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
