| 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 |
| Manufacturer |
Adamed Pharma S.A., Czosnow, Poljska |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
29.05.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/121 |
| Registration Number |
381-12-01/171-25-03 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
C03DA04 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
