| Name |
Kabazitaksel Viatris 20 mg/ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-676395661 |
| Active Substance |
kabazitaksel |
| Composition |
jedan ml koncentrata sadrži 20 mg kabazitaksela
jedna bočica s 3 ml koncentrata sadrži 60 mg kabazitaksela |
| Pharmaceutical Form |
Koncentrat za otopinu za infuziju |
| Manufacturer |
AqVida GmbH, Hamburg, Njemačka |
| Marketing Authorisation Holder |
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date |
21.04.2022 |
| MA Period of Validity |
21.04.2027 |
| Classification Number |
UP/I-530-09/21-01/276 |
| 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 |
L01CD04 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
