Etoposide Sandoz 20 mg/ml koncentrat za otopinu za infuziju

Name	Etoposide Sandoz 20 mg/ml koncentrat za otopinu za infuziju
Former Name	Etoposide Ebewe 20 mg/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number	HR-H-578166910
Active Substance	etopozid
Composition	1 ml koncentrata za otopinu za infuziju sadrži 20 mg etopozida
Pharmaceutical Form	koncentrat za otopinu za infuziju
Manufacturer	Ebewe Pharma GmbH Nfg. KG, Unterach am Attersee, Austrija Fareva Unterach GmbH, Unterach, Austrija
Marketing Authorisation Holder	Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date	28.05.2018
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/17-02/178
Registration Number	381-12-01/38-18-08
Prescription	na recept
Type of prescription	ograničeni recept
Distribution	u ljekarni
Advertising to general public	zabranjeno
ATC Code	L01CB01
Medicinal product marketed in the Croatia	Da
SmPC	download
PL	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s 2,5 ml koncentrata, u kutiji	HR-H-578166910-01	-	-
1 bočica s 5 ml koncentrata, u kutiji	HR-H-578166910-02	-	-
1 bočica s 10 ml koncentrata, u kutiji	HR-H-578166910-03	-	-
1 bočica s 20 ml koncentrata, u kutiji	HR-H-578166910-04	-	-
1 bočica s 50 ml koncentrata, u kutiji	HR-H-578166910-05	-	-

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o riziku od reakcija preosjetljivosti povezanih s infuzijom lijekova koji sadrže etopozid, kada se primjenjuju s ugrađenim filtrima	18.01.2024	Sandoz d.o.o.