Yolatin 6 mg/0,4 mg tablete s prilagođenim oslobađanjem
Name | Yolatin 6 mg/0,4 mg tablete s prilagođenim oslobađanjem |
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Marketing Authorisation Number | HR-H-882007648 |
Active Substance | solifenacinsukcinat tamsulozinklorid |
Composition | jedna tableta sadrži 6 mg solifenacinsukcinata, što odgovara 4,5 mg solifenacina i 0,4 mg tamsulozinklorida, što odgovara 0,37 mg tamsulozina |
Pharmaceutical Form | Tableta s prilagođenim oslobađanjem |
Manufacturer | Synthon BV, Nijmegen, Nizozemska
Synthon Hispania S.L., Sant Boi de Llobregat, Španjolska Synthon s.r.o., Blansko, Češka |
Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
Marketing Authorisation Date | 16.05.2023 |
MA Period of Validity | 16.05.2028 |
Classification Number | UP/I-530-09/21-01/105 |
Registration Number | 381-12-01/70-23-08 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | ponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | G04CA53 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |