Irinotesin 20 mg/ml koncentrat za otopinu za infuziju
| Name | Irinotesin 20 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-810518111 |
| Active Substance | irinotekanklorid trihidrat |
| Composition | jedan ml koncentrata sadrži 20 mg irinotekanklorid trihidrata što odgovara 17,33 mg/ml irinotekana |
| Pharmaceutical Form | koncentrat za otopinu za infuziju |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska Actavis Italy S.p.A., Nerviano (Milano), Italija |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 02.12.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/248 |
| Registration Number | 381-12-01/154-20-18 |
| 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
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. |
