Vankomicin Viatris 500 mg prašak za otopinu za infuziju
Name | Vankomicin Viatris 500 mg prašak za otopinu za infuziju |
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Marketing Authorisation Number | HR-H-480546136 |
Active Substance | vankomicinklorid |
Composition | svaka bočica sadrži 500 mg vankomicina (u obliku klorida), što odgovara 500 000 IU |
Pharmaceutical Form | prašak za otopinu za infuziju |
Manufacturer | Viatris Sante , Lyon, Francuska Biologici Italia Laboratories S.r.l., Masate, Italija Vianex S.A., Pallini, Attiki, Grčka |
Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
Marketing Authorisation Date | 20.03.2023 |
MA Period of Validity | 20.03.2028 |
Classification Number | UP/I-530-09/22-01/62 |
Registration Number | 381-12-01/70-23-09 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J01XA01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |