| Name |
Silymarin tvrde kapsule |
| Former Name |
Silymarin kapsule |
| Marketing Authorisation Number |
HR-H-493353886 |
| Active Substance |
sikavičin suhi ekstrakt, rafiniran i normiran |
| Composition |
jedna tvrda kapsula sadrži 168,35 – 205,76 mg ekstrakta (kao suhi ekstrakt, rafiniran i normiran) iz Silybum marianum L. Gaertner, fructus (sikavičin plod) (22–27 : 1) što odgovara 100 mg silimarina izraženo kao silibinin.
Ekstrakcijsko otapalo: aceton 95% V/V |
| Pharmaceutical Form |
kapsula, tvrda |
| Manufacturer |
Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder |
Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date |
28.09.2016 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/14-02/390 |
| Registration Number |
381-12-01/70-16-08 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) and non-pharmacy outlets |
| Advertising to general public |
allowed |
| ATC Code |
A05BA03 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
