Fluorouracil Sandoz 50 mg/ml otopina za injekciju/infuziju
| Name | Fluorouracil Sandoz 50 mg/ml otopina za injekciju/infuziju |
|---|---|
| Former Name | Fluorouracil Ebewe 50 mg/ml otopina za injekciju/infuziju |
| Marketing Authorisation Number | HR-H-126689750 |
| Active Substance | fluorouracil |
| Composition | 1 ml otopine za injekciju/infuziju sadrži 50 mg fluorouracila (u obliku natrijeve soli nastale „in situ“) |
| Pharmaceutical Form | Otopina za injekciju / infuziju |
| Packaging [MA Number for Packaging] | 1 bočica s 5 ml otopine, u kutiji [HR-H-126689750-01] 1 bočica s 10 ml otopine, u kutiji [HR-H-126689750-02] 1 bočica s 20 ml otopine, u kutiji [HR-H-126689750-03] 1 bočica s 50 ml otopine, u kutiji [HR-H-126689750-04] 1 bočica sa 100 ml otopine, u kutiji [HR-H-126689750-05] |
| Manufacturer | Ebewe Pharma GmbH Nfg. KG, Unterach am Attersee, Austrija Fareva Unterach GmbH, Unterach, Austrija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 10.02.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/583 |
| Registration Number | 381-12-01/38-20-07 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01BC02 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o potrebi testiranja bolesnika prije započinjanja liječenja lijekovima s djelatnim tvarima fluorouracil, kapecitabin ili tegafur radi utvrđivanja mogućeg nedostatka DPD enzima koji bolesnike izlaže povećanom riziku od teške toksičnosti | 04.06.2020 | Roche Registration GmbH, Jadran Galenski laboratorij d.d. (JGL), Alpha-Medical d.o.o., Sandoz d.o.o., Alvogen Pharma Trading Europe EOOD, Pliva Hrvatska d.o.o., Krka-farma d.o.o., Teva B.V., Accord Healthcare S.L.U. |
