Kaspofungin PharmaS 50 mg prašak za koncentrat za otopinu za infuziju
| Name | Kaspofungin PharmaS 50 mg prašak za koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-271238324 |
| Active Substance | kaspofunginacetat |
| Composition | jedna bočica sadrži 50 mg kaspofungina (u obliku acetata) |
| Pharmaceutical Form | prašak za koncentrat za otopinu za infuziju |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta SAG Manufacturing S.L.U., San Agustin del Guadalix, Madrid, Španjolska Hikma Italia S.p.A., Pavia, Italija Galenicum Health S.L.U., Esplugues de Llobregat, Barcelona, Španjolska |
| Marketing Authorisation Holder | PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
| Marketing Authorisation Date | 12.07.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/24 |
| Registration Number | 381-12-01/154-22-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J02AX04 |
| Marketing status | stavljeno u promet |
| Shortage status | u tijeku |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o potrebi izbjegavanja primjene poliakrilonitrilskih membrana tijekom kontinuirane bubrežne nadomjesne terapije u bolesnika na terapiji lijekovima koji sadrže kaspofungin | 09.10.2025 | PharmaS d.o.o., Pliva Hrvatska d.o.o., Zentiva, k.s, Ligula Pharma d.o.o., Rhei Life d.o.o./Marti Farm d.o.o. |