| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
ponovljivi recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A05AA02 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
