Medicinal Products
Ondanzetron Kabi 2 mg/ml otopina za injekciju/infuziju
| Name |
Ondanzetron Kabi 2 mg/ml otopina za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-556361249 |
| Active Substance |
ondanzetronklorid dihidrat |
| Composition |
1 ml otopine sadrži 2 mg ondanzetrona u obliku ondanzetronklorida dihidrata |
| Pharmaceutical Form |
Otopina za injekciju / infuziju |
| Manufacturer |
Labesfal - Laboratorios Almiro S.A., Campo de Besteiros, Portugal |
| Marketing Authorisation Holder |
Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date |
06.06.2017 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/16-02/44 |
| Registration Number |
381-12-01/70-17-10 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
ograničeni recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A04AA01 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Summary of risk management plan |
download |
Packaging
| Packaging description |
MA Number for Packaging |
Marketing status |
Shortage status |
| 5 ampula s 2 ml otopine, u kutiji |
HR-H-556361249-01 |
stavljeno u promet |
nema nestašice |
| 5 ampula s 4 ml otopine, u kutiji |
HR-H-556361249-02 |
stavljeno u promet |
nema nestašice |
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