Pleriksafor Onkogen 20 mg/ml otopina za injekciju
| Name | Pleriksafor Onkogen 20 mg/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-288263728 |
| Active Substance | pleriksafor |
| Composition | 1 ml otopine sadrži 20 mg pleriksafora jedna bočica sadrži 24 mg pleriksafora u 1,2 ml otopine |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | Seacross Pharma (Europe) Limited, Dublin, Irska Seacross Pharma (Europe) Limited, Dublin, Irska |
| Marketing Authorisation Holder | Onkogen Kft., Becsi Ut 77-79, Budimpešta, Mađarska |
| Marketing Authorisation Date | 21.02.2023 |
| MA Period of Validity | 21.02.2028 |
| Classification Number | UP/I-530-09/21-01/206 |
| Registration Number | 381-12-01/70-23-11 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L03AX16 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
