Beplasot 6 mg/0,4 mg tablete s prilagođenim oslobađanjem
| Name | Beplasot 6 mg/0,4 mg tablete s prilagođenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-968217007 |
| Active Substance | solifenacinsukcinat tamsulozinklorid |
| Composition | jedna tableta sadrži 6 mg solifenacinsukcinata, što odgovara 4,5 mg solifenacina i 0,4 mg tamsulozinklorida, što odgovara 0,37 mg tamsulozina |
| Pharmaceutical Form | Tableta s prilagođenim oslobađanjem |
| Manufacturer | Synthon s.r.o., Blansko, Češka
Synthon Hispania S.L., Sant Boi de Llobregat, Španjolska Synthon BV, Nijmegen, Nizozemska Genericon Pharma Gesellschaft m.b.H., Graz, Austrija |
| Marketing Authorisation Holder | Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
| Marketing Authorisation Date | 17.05.2023 |
| MA Period of Validity | 17.05.2028 |
| Classification Number | UP/I-530-09/21-01/106 |
| Registration Number | 381-12-01/154-23-07 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G04CA53 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
