Name |
Xapla 50 mg filmom obložene tablete |
Marketing Authorisation Number |
HR-H-342034866 |
Active Substance |
eplerenon |
Composition |
jedna tableta sadrži 50 mg eplerenona |
Pharmaceutical Form |
filmom obložena tableta |
Packaging [MA Number for Packaging] |
30 tableta u blisteru, u kutiji [HR-H-342034866-01]
|
Manufacturer |
Adamed Pharma S.A., Czosnow, Poljska |
Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
Marketing Authorisation Date |
28.05.2020 |
MA Period of Validity |
28.05.2025 |
Classification Number |
UP/I-530-09/18-01/104 |
Registration Number |
381-12-01/38-20-07 |
Prescription |
na recept |
Type of prescription |
ponovljivi recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
C03DA04 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |