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 |