Name |
Abutrax 5 mg/ml prašak za disperziju za infuziju |
Marketing Authorisation Number |
HR-H-793701682 |
Active Substance |
paklitaksel |
Composition |
jedna bočica sadrži 100 mg paklitaksela u obliku nanočestica vezanih na albumin nakon rekonstitucije, jedan ml disperzije sadrži 5 mg paklitaksela u obliku nanočestica vezanih na albumin |
Pharmaceutical Form |
Prašak za disperziju za infuziju |
Manufacturer |
STADA Arzneimittel AG, Bad Vilbel, Njemačka |
Marketing Authorisation Holder |
Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
Marketing Authorisation Date |
09.05.2024 |
MA Period of Validity |
09.05.2029 |
Classification Number |
UP/I-530-09/21-01/259 |
Registration Number |
381-12-01/70-24-07 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
L01CD01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|