Gitrabin 1000 mg prašak za otopinu za infuziju
Name | Gitrabin 1000 mg prašak za otopinu za infuziju |
---|---|
Marketing Authorisation Number | HR-H-808889278 |
Active Substance | gemcitabinklorid |
Composition | svaka bočica sadrži 1000 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-530-09/15-02/36 |
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 |