Piperacilin/tazobaktam Qilu 4 g/0,5 g prašak za otopinu za infuziju
Name | Piperacilin/tazobaktam Qilu 4 g/0,5 g prašak za otopinu za infuziju |
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Marketing Authorisation Number | HR-H-878898010 |
Active Substance | piperacilinnatrij tazobaktamnatrij |
Composition | svaka bočica sadrži 4 g piperacilina (u obliku piperacilinnatrija) i 0,5 g tazobaktama (u obliku tazobaktamnatrija) |
Pharmaceutical Form | prašak za otopinu za infuziju |
Manufacturer | Kymos S.L., Cerdanyola del Valles, Barcelona, Španjolska Unifarma SIA, Riga, Latvija Eurofins Analytical Services Hungary Kft., Budimpešta, Mađarska |
Marketing Authorisation Holder | Qilu Pharma Spain S.L., Paseo de la Castellana 40, planta 8, Madrid, Španjolska |
Marketing Authorisation Date | 06.04.2023 |
MA Period of Validity | 06.04.2028 |
Classification Number | UP/I-530-09/21-01/113 |
Registration Number | 381-12-01/171-23-11 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J01CR05 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |