Actonel Combi D 35 mg filmom obložene tablete + 1000 mg / 880 IU šumeće granule
| Name | Actonel Combi D 35 mg filmom obložene tablete + 1000 mg / 880 IU šumeće granule |
|---|---|
| Marketing Authorisation Number | HR-H-648885316 |
| Active Substance | natrijev risedronat kalcijev karbonat kolekalciferol, koncentrat, prašak |
| Composition | jedna filmom obložena tableta sadrži 35 mg natrijevog risedronata (što odgovara količini od 32,5 mg risedronatne kiseline); jedna vrećica šumećih granula sadrži 1000 mg kalcija (u obliku 2500 mg kalcijevog karbonata) i 22 mikrograma (880 IU) kolekalciferola (vitamin D3) |
| Pharmaceutical Form | šumeće granule + filmom obložena tableta |
| Manufacturer | Hermes Pharma Ges.m.b.H., Wolfsberg, Austrija |
| 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-530-09/18-02/100 |
| Registration Number | 381-12-01/70-25-64 |
| 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 | M05BB04 |
| Marketing status | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
