Ondanzetron Kabi 0,08 mg/ml otopina za infuziju
Name | Ondanzetron Kabi 0,08 mg/ml otopina za infuziju |
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Marketing Authorisation Number | HR-H-602841677 |
Active Substance | ondanzetronklorid dihidrat |
Composition | 1 ml otopine za infuziju sadrži 0.08 mg ondansetrona (u obliku ondanzetronklorid dihidrata) 1 bočica s 50 ml otopine sadrži 4 mg ondanzetrona 1 bočica sa 100 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-530-09/22-01/141 |
Registration Number | 381-12-01/38-23-07 |
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 |