Urotrim Duo 6 mg/0,4 mg tablete s prilagođenim oslobađanjem
| Name | Urotrim Duo 6 mg/0,4 mg tablete s prilagođenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-577396975 |
| Active Substance | solifenacinsukcinat tamsulozinklorid |
| Composition | jedna tableta sadrži sloj sa 6 mg solifenacinsukcinata što odgovara 4,5 mg slobodne baze solifenacina i sloj sa 0,4 mg tamsulozinklorida što odgovara 0,37 mg slobodne baze tamsulozina |
| Pharmaceutical Form | tableta s prilagođenim oslobađanjem |
| Manufacturer | Adamed Pharma S.A., Pabianice, Poljska
AdAlvo Limited, San Gwann, Malta |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 18.01.2023 |
| MA Period of Validity | 18.01.2028 |
| Classification Number | UP/I-530-09/21-01/301 |
| Registration Number | 381-12-01/70-23-09 |
| 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 |
