Name |
Felkarid 100 mg tablete |
Marketing Authorisation Number |
HR-H-144132696 |
Active Substance |
flekainidacetat |
Composition |
jedna tableta sadrži 100 mg flekainidacetata |
Pharmaceutical Form |
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 |
22.04.2021 |
MA Period of Validity |
22.04.2026 |
Classification Number |
UP/I-530-09/19-01/171 |
Registration Number |
381-12-01/70-21-03 |
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 |
C01BC04 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |