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 |
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 |
Medicinal product subject to medical prescription |
Type of prescription |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
L01CD04 |
Marketing status |
stavljeno u promet |
Shortage status |
u tijeku |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|