Ondanzetron Kabi 0,08 mg/ml otopina za infuziju
| Name | Ondanzetron Kabi 0,08 mg/ml otopina za infuziju |
|---|---|
| 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 |
