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	Medicinal product subject to medical prescription
Type of prescription	Medicinal product subject to restricted medical prescription
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	A04AA01
Marketing status	Never marketed
SmPC	download
PL	download
Public Assessment Report	download
Summary of risk management plan	download

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s 50 ml otopine, u kutiji	HR-H-602841677-01	Never marketed	-
10 bočica s 50 ml otopine, u kutiji	HR-H-602841677-02	Never marketed	-
20 bočica s 50 ml otopine, u kutiji	HR-H-602841677-03	Never marketed	-
40 bočica s 50 ml otopine, u kutiji	HR-H-602841677-04	Never marketed	-
1 bočica sa 100 ml otopine, u kutiji	HR-H-602841677-05	Never marketed	-
10 bočica sa 100 ml otopine, u kutiji	HR-H-602841677-06	Never marketed	-
20 bočica sa 100 ml otopine, u kutiji	HR-H-602841677-07	Never marketed	-
40 bočica sa 100 ml otopine, u kutiji	HR-H-602841677-08	Never marketed	-

Medicinal Products