Fludarabin Pliva 25 mg/ml koncentrat za otopinu za injekciju/infuziju
| Name | Fludarabin Pliva 25 mg/ml koncentrat za otopinu za injekciju/infuziju |
|---|---|
| Former Name | Fludarabine - Teva 25 mg/ml |
| Marketing Authorisation Number | HR-H-680212253 |
| Active Substance | fludarabinfosfat |
| Composition | bočica s 2 ml koncentrata za otopinu za injekciju/infuziju sadrži 50 mg fludarabinfosfata |
| Pharmaceutical Form | Koncentrat za otopinu za injekciju / infuziju |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Pharmachemie B.V., Haarlem, Nizozemska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 05.09.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/18 |
| Registration Number | 381-12-01/38-19-06 |
| 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 | Da |
| SmPC | download |
| PL | download |
