Gemcitabin Kabi 1000 mg prašak za otopinu za infuziju
| Name | Gemcitabin Kabi 1000 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-968252215 |
| Active Substance | gemcitabinklorid |
| Composition | jedna bočica sadrži 1000 mg gemcitabina (u obliku gemcitabinklorida) nakon rekonstitucije s 25 ml otapala 1 ml rekonstituirane otopine sadrži 38 mg gemcitabina |
| Pharmaceutical Form | prašak za otopinu za infuziju |
| Manufacturer | Fresenius Kabi Oncology Plc., Bordon Hampshire, Ujedinjeno Kraljevstvo Fresenius Kabi Deutschland GmbH, Friedberg, Njemačka |
| Marketing Authorisation Holder | Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date | 18.01.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/15 |
| Registration Number | 381-12-01/70-19-02 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01BC05 |
| Medicinal product marketed in the Croatia | Nestašica |
| SmPC | download |
| PL | download |
