| Name |
Actonel 35 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-350046678 |
| Active Substance |
natrijev risedronat |
| Composition |
jedna filmom obložena tableta sadržava 35 mg natrijevog risedronata (što odgovara količini od 32,5 mg risedronatne kiseline) |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder |
Theramex Ireland Limited, 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin, Irska |
| Marketing Authorisation Date |
05.09.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/14-02/50 |
| Registration Number |
381-12-01/70-25-79 |
| 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 |
M05BA07 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
