Name |
Docetaksel Zentiva 20 mg/ml koncentrat za otopinu za infuziju |
Marketing Authorisation Number |
HR-H-811027832 |
Active Substance |
docetaksel |
Composition |
svaki ml koncentrata sadrži 20 mg docetaksela |
Pharmaceutical Form |
Koncentrat za otopinu za infuziju |
Manufacturer |
AqVida GmbH, Hamburg, Njemačka |
Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
Marketing Authorisation Date |
05.07.2023 |
MA Period of Validity |
05.07.2028 |
Classification Number |
UP/I-530-09/23-01/44 |
Registration Number |
381-12-01/286-23-06 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
L01CD02 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |