| Name |
Xapla 25 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-277676854 |
| Active Substance |
eplerenon |
| Composition |
jedna tableta sadrži 25 mg eplerenona |
| Pharmaceutical Form |
filmom obložena tableta |
| Packaging [MA Number for Packaging] |
30 tableta u blisteru, u kutiji [HR-H-277676854-01]
|
| 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-530-09/18-01/103 |
| Registration Number |
381-12-01/38-20-14 |
| 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 |
