| Name |
Icalziss 340 mmol/L otopina za infuziju |
| Marketing Authorisation Number |
HR-H-203239038 |
| Active Substance |
kalcijev klorid dihidrat |
| Composition |
1000 ml otopine sadrži 50 g kalcijevog klorida dihidrata odnosno 340 mmola kalcija i 680 mmola klorida |
| Pharmaceutical Form |
Otopina za infuziju |
| Manufacturer |
Bieffe Medital S.A., Sabinanigo (Huesca), Španjolska |
| Marketing Authorisation Holder |
Vantive Belgium SRL, Boulevard d'Angleterre 2, Braine-l'Alleud, Belgija |
| Marketing Authorisation Date |
20.12.2024 |
| MA Period of Validity |
20.12.2029 |
| Classification Number |
UP/I-530-09/23-01/198 |
| Registration Number |
381-12-01/171-24-10 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
B05XA07 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
