Urotrim 10 mg filmom obložene tablete
Name | Urotrim 10 mg filmom obložene tablete |
---|---|
Former Name | Solifenacin Pliva 10 mg filmom obložene tablete |
Marketing Authorisation Number | HR-H-524538098 |
Active Substance | solifenacinsukcinat |
Composition | svaka filmom obložena tableta sadrži 10 mg solifenacinsukcinata, što odgovara 7,5 mg solifenacina |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 3 tablete u blisteru, u kutiji [HR-H-524538098-01] 5 tableta u blisteru, u kutiji [HR-H-524538098-02] 10 tableta u blisteru, u kutiji [HR-H-524538098-03] 20 tableta u blisteru, u kutiji [HR-H-524538098-04] 30 tableta u blisteru, u kutiji [HR-H-524538098-05] 50 tableta u blisteru, u kutiji [HR-H-524538098-06] 60 tableta u blisteru, u kutiji [HR-H-524538098-07] 90 tableta u blisteru, u kutiji [HR-H-524538098-08] 100 tableta u blisteru, u kutiji [HR-H-524538098-09] 200 tableta u blisteru, u kutiji [HR-H-524538098-10] 30 tableta u bočici, u kutiji [HR-H-524538098-11] 100 tableta u bočici, u kutiji [HR-H-524538098-12] 100 tableta u bočici,2 bočice u kutiji [HR-H-524538098-13] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-524538098-14] |
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 Teva Operations Poland Sp. z o.o., Krakow, Poljska Pliva Hrvatska d.o.o., Zagreb, Hrvatska 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-530-09/18-02/21 |
Registration Number | 381-12-01/70-18-02 |
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 |