Irinotekan Kabi 20 mg/ml koncentrat za otopinu za infuziju

Name	Irinotekan Kabi 20 mg/ml koncentrat za otopinu za infuziju
Former Name	Irinotecan Kabi 20 mg/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number	HR-H-885268744
Active Substance	irinotekanklorid trihidrat
Composition	1 ml koncentrata za otopinu za infuziju sadrži 20 mg irinotekanklorid trihidrata što odgovara 17,33 mg irinotekana
Pharmaceutical Form	koncentrat za otopinu za infuziju
Manufacturer	Fresenius Kabi Deutschland GmbH, Friedberg, Njemačka
Marketing Authorisation Holder	Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska
Marketing Authorisation Date	29.08.2018
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/17-02/840
Registration Number	381-12-01/70-18-08
Prescription	na recept
Type of prescription	ograničeni recept
Distribution	u ljekarni
Advertising to general public	zabranjeno
ATC Code	L01CE02
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 ml koncentrata, u kutiji	HR-H-885268744-01	-	-
1 bočica s 5 ml koncentrata, u kutiji	HR-H-885268744-02	-	-
1 bočica s 15 ml koncentrata, u kutiji	HR-H-885268744-03	-	-
1 bočica s 25 ml koncentrata, u kutiji	HR-H-885268744-04	-	-

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o neželjenim učincima lijekova koji sadrže irinotekanklorid trihidrat u bolesnika sa smanjenom aktivnošću enzima UGT1A1	14.04.2022	Pliva Hrvatska d.o.o., PharmaS d.o.o., Fresenius Kabi d.o.o.