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	ograničeni recept
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	L01CE02
Marketing status	stavljeno u promet
Shortage status	nema nestašice
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	stavljeno u promet	nema nestašice
1 bočica s 5 ml koncentrata, u kutiji	HR-H-879693802-02	stavljeno u promet	nema nestašice
1 bočica s 15 ml koncentrata, u kutiji	HR-H-879693802-03	stavljeno u promet	nema nestašice
1 bočica s 25 ml koncentrata, u kutiji	HR-H-879693802-04	stavljeno u promet	nema nestašice
1 bočica s 50 ml koncentrata, u kutiji	HR-H-879693802-05	stavljeno u promet	nema nestašice

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.