| Name |
Dekristol 50 000 IU tvrde kapsule |
| Marketing Authorisation Number |
HR-H-911576302 |
| Active Substance |
kolekalciferol |
| Composition |
jedna tvrda kapsula sadrži 1,25 mg kolekalciferola (što odgovara 50 000 IU vitamina D3) |
| Pharmaceutical Form |
Kapsula, tvrda |
| Manufacturer |
mibe GmbH Arzneimittel, Brehna, Njemačka |
| Marketing Authorisation Holder |
Mibe Pharmaceuticals d.o.o., Zavrtnica 17, Zagreb, Hrvatska |
| Marketing Authorisation Date |
03.09.2024 |
| MA Period of Validity |
03.09.2029 |
| Classification Number |
UP/I-530-09/21-01/261 |
| Registration Number |
381-12-01/286-24-07 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for non-renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A11CC05 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
