Irinotekan Accord 20 mg/ml koncentrat za otopinu za infuziju

Name	Irinotekan Accord 20 mg/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number	HR-H-879693802
Active Substance	irinotekanklorid trihidrat
Composition	1 ml koncentrata sadrži 20 mg irinotekanklorid trihidrata, što odgovara 17,33 mg irinotekana
Pharmaceutical Form	koncentrat za otopinu za infuziju
Manufacturer	Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare Single Member S.A., Lamia, Grčka
Marketing Authorisation Holder	Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska
Marketing Authorisation Date	11.06.2021
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/20-02/108
Registration Number	381-12-01/154-21-03
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	L01CE02
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
1 bočica s 2 ml koncentrata, u kutiji	HR-H-879693802-01	Marketed	No shortage
1 bočica s 5 ml koncentrata, u kutiji	HR-H-879693802-02	Marketed	No shortage
1 bočica s 15 ml koncentrata, u kutiji	HR-H-879693802-03	Marketed	No shortage
1 bočica s 25 ml koncentrata, u kutiji	HR-H-879693802-04	Marketed	No shortage
1 bočica s 50 ml koncentrata, u kutiji	HR-H-879693802-05	Marketed	No shortage

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.