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 |