Zeliftan 6 mg/0,4 mg tablete s prilagođenim oslobađanjem
| Name | Zeliftan 6 mg/0,4 mg tablete s prilagođenim oslobađanjem |
|---|---|
| Marketing Authorisation Number | HR-H-136479372 |
| Active Substance | solifenacinsukcinat tamsulozinklorid |
| Composition | jedna tableta sadrži sloj sa 6 mg solifenacinsukcinata, što odgovara 4,5 mg slobodne baze solifenacina, i sloj s 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 | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 23.01.2023 |
| MA Period of Validity | 23.01.2028 |
| Classification Number | UP/I-530-09/21-01/111 |
| Registration Number | 381-12-01/171-23-09 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | G04CA53 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
