Urotrim 5 mg filmom obložene tablete
| Name | Urotrim 5 mg filmom obložene tablete |
|---|---|
| Former Name | Solifenacin Pliva 5 mg filmom obložene tablete |
| Marketing Authorisation Number | HR-H-460073486 |
| Active Substance | solifenacinsukcinat |
| Composition | svaka filmom obložena tableta sadrži 5 mg solifenacinsukcinata, što odgovara 3,8 mg solifenacina |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Teva Pharmaceutical Works Private Limited Company, Debrecen, Mađarska Teva Czech Industries s.r.o., Opava-Komarov, Češka Merckle GmbH, Blaubeuren, Njemačka Merckle GmbH, Ulm, Njemačka Teva Pharma B.V., Haarlem, Nizozemska Pliva Hrvatska d.o.o., Zagreb, Hrvatska Teva Operations Poland Sp. z o.o., Krakow, Poljska Qualiphar N.V., Bornem, Belgija Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 23.01.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/20 |
| Registration Number | 381-12-01/70-25-29 |
| 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 | G04BD08 |
| Marketing status | Marketed |
| Shortage status | Actual |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
