Solifenacinsukcinat/tamsulozinklorid Viatris 6 mg/0,4 mg tablete s prilagođenim oslobađanjem
| Name | Solifenacinsukcinat/tamsulozinklorid Viatris 6 mg/0,4 mg tablete s prilagođenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-195727064 |
| Active Substance | solifenacinsukcinat tamsulozinklorid |
| Composition | svaka 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 BV, Nijmegen, Nizozemska Synthon Hispania S.L., Sant Boi de Llobregat, Španjolska |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 27.06.2023 |
| MA Period of Validity | 27.06.2028 |
| Classification Number | UP/I-530-09/21-01/108 |
| Registration Number | 381-12-01/286-23-08 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G04CA53 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
