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 |
| Packaging [MA Number for Packaging] | 3 tablete u blisteru, u kutiji [HR-H-460073486-01] 5 tableta u blisteru, u kutiji [HR-H-460073486-02] 10 tableta u blisteru, u kutiji [HR-H-460073486-03] 20 tableta u blisteru, u kutiji [HR-H-460073486-04] 30 tableta u blisteru, u kutiji [HR-H-460073486-05] 50 tableta u blisteru, u kutiji [HR-H-460073486-06] 60 tableta u blisteru, u kutiji [HR-H-460073486-07] 90 tableta u blisteru, u kutiji [HR-H-460073486-08] 100 tableta u blisteru, u kutiji [HR-H-460073486-09] 200 tableta u blisteru, u kutiji [HR-H-460073486-10] 30 tableta u bočici, u kutiji [HR-H-460073486-11] 100 tableta u bočici, u kutiji [HR-H-460073486-12] 100 tableta u bočici, 2 bočice u kutiji [HR-H-460073486-13] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-460073486-14] |
| Manufacturer | Teva Pharmaceutical Works Private Limited Company, Debrecen, Mađarska Teva Czech Industries s.r.o., Opava-Komarov, Češka Merckle GmbH, Blaubeuren, Baden-Wuerttemberg, 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 |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 23.07.2018 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/20 |
| Registration Number | 381-12-01/70-18-03 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G04BD08 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
