Name |
Ondanzetron Kabi 0,16 mg/ml otopina za infuziju |
Marketing Authorisation Number |
HR-H-272776579 |
Active Substance |
ondanzetronklorid dihidrat |
Composition |
1 ml otopine za infuziju sadrži 0,16 mg ondansetrona (u obliku ondanzetronklorid dihidrata)
1 bočica s 50 ml otopine sadrži 8 mg ondanzetrona |
Pharmaceutical Form |
Otopina za infuziju |
Manufacturer |
Fresenius Kabi Polska Sp. z o.o., Kutno, Poljska |
Marketing Authorisation Holder |
Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
Marketing Authorisation Date |
15.03.2023 |
MA Period of Validity |
15.03.2028 |
Classification Number |
UP/I-530-09/22-01/142 |
Registration Number |
381-12-01/38-23-05 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
A04AA01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |