| Name |
Eleber 60 mg koncentrat i otapalo za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-561829137 |
| Active Substance |
kabazitaksel |
| Composition |
jedna bočica s 1,5 ml koncentrata sadrži 60 mg kabazitaksela
nakon razrijeđivanja s otapalom jedan ml otopine sadrži 10 mg kabazitaksela |
| Pharmaceutical Form |
koncentrat i otapalo za otopinu za infuziju |
| Packaging [MA Number for Packaging] |
1 bočica s koncentratom i 1 bočica s otapalom, u kutiji [HR-H-561829137-01]
|
| Manufacturer |
Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date |
21.04.2021 |
| MA Period of Validity |
21.04.2026 |
| Classification Number |
UP/I-530-09/20-01/33 |
| Registration Number |
381-12-01/70-21-04 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
L01CD04 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
