Sindarabin 50 mg prašak za otopinu za injekciju/infuziju
| Name | Sindarabin 50 mg prašak za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-916786402 |
| Active Substance | fludarabinfosfat |
| Composition | svaka bočica sadrži 50 mg fludarabinfosfata; 1 ml pripremljene otopine sadrži 25 mg fludarabinfosfata |
| Pharmaceutical Form | prašak za otopinu za injekciju/infuziju |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| Marketing Authorisation Holder | Actavis Group PTC ehf., Reykjavikurvegur 76-78, Hafnarfjordur, Island |
| Marketing Authorisation Date | 30.07.2018 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/401 |
| Registration Number | 381-12-01/70-18-07 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01BB05 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
