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 |
| Packaging [MA Number for Packaging] | 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] |
| 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 |
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. |
