Gemcitabin Sandoz 40 mg/ml koncentrat za otopinu za infuziju
| Name | Gemcitabin Sandoz 40 mg/ml koncentrat za otopinu za infuziju |
|---|---|
| Former Name | Gemcitabine Ebewe 200 mg/ 5 ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number | HR-H-343193993 |
| Active Substance | gemcitabinklorid |
| Composition | 1 ml koncentrata za otopinu za infuziju sadrži 40 mg gemcitabina u obliku gemcitabinklorida |
| Pharmaceutical Form | koncentrat za otopinu za infuziju |
| 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 | 19.09.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/376 |
| Registration Number | 381-12-01/70-17-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01BC05 |
| Marketing status | stavljeno u promet |
| Shortage status | u tijeku |
| SmPC | download |
| PL | download |
