Gitrabin 2000 mg prašak za otopinu za infuziju
| Name | Gitrabin 2000 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-537432592 |
| Active Substance | gemcitabinklorid |
| Composition | svaka bočica sadrži 2000 mg gemcitabina (u obliku gemcitabinklorida) |
| Pharmaceutical Form | prašak 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 | 07.10.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/15-02/37 |
| Registration Number | 381-12-01/70-20-12 |
| 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 | Da |
| SmPC | download |
| PL | download |
