Name |
Tiotepa Fresenius Kabi 100 mg prašak za koncentrat za otopinu za infuziju |
Marketing Authorisation Number |
HR-H-769572882 |
Active Substance |
tiotepa |
Composition |
jedna bočica praška sadrži 100 mg tiotepe nakon rekonstitucije s 10 ml vode za injekcije, svaki ml otopine sadrži 10 mg tiotepe (10 mg/ml) |
Pharmaceutical Form |
Prašak za koncentrat za otopinu za infuziju |
Manufacturer |
Fresenius Kabi Deutschland GmbH, Friedberg, Njemačka |
Marketing Authorisation Holder |
Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
Marketing Authorisation Date |
24.03.2023 |
MA Period of Validity |
24.03.2028 |
Classification Number |
UP/I-530-09/20-01/310 |
Registration Number |
381-12-01/38-23-08 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
L01AC01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|