Pleriksafor Sandoz 20 mg/ml otopina za injekciju
Name | Pleriksafor Sandoz 20 mg/ml otopina za injekciju |
---|---|
Marketing Authorisation Number | HR-H-380314498 |
Active Substance | pleriksafor |
Composition | 1 ml otopine za injekciju sadrži 20 mg pleriksafora svaka bočica s 1,2 ml otopine za injekciju sadrži 24 mg pleriksafora |
Pharmaceutical Form | otopina za injekciju |
Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 30.11.2023 |
MA Period of Validity | 30.11.2028 |
Classification Number | UP/I-530-09/21-01/245 |
Registration Number | 381-12-01/70-23-06 |
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 |