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 |
| Packaging [MA Number for Packaging] | 1 bočica s 2 ml koncentrata, u kutiji [HR-H-879693802-01] 1 bočica s 5 ml koncentrata, u kutiji [HR-H-879693802-02] 1 bočica s 15 ml koncentrata, u kutiji [HR-H-879693802-03] 1 bočica s 25 ml koncentrata, u kutiji [HR-H-879693802-04] 1 bočica s 50 ml koncentrata, u kutiji [HR-H-879693802-05] |
| Manufacturer | Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare B.V., Utrecht, Nizozemska |
| 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 | 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 |
| Public Assessment Report | 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. |
