Ezetimib/atorvastatin Alkaloid-INT 10 mg/20 mg filmom obložene tablete
Name | Ezetimib/atorvastatin Alkaloid-INT 10 mg/20 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-895524846 |
Active Substance | ezetimib atorvastatinkalcij trihidrat |
Composition | jedna filmom obložena tableta sadrži 10 mg ezetimiba i 20 mg atorvastatina (u obliku atorvastatinkalcij trihidrata) |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Holder | Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Date | 06.06.2024 |
MA Period of Validity | 06.06.2029 |
Classification Number | UP/I-530-09/22-01/207 |
Registration Number | 381-12-01/70-24-05 |
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 | C10BA05 |
Marketing status | nije stavljeno u promet |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |