Vankomicin Viatris 500 mg prašak za otopinu za infuziju
| Name | Vankomicin Viatris 500 mg prašak za otopinu za infuziju |
|---|---|
| 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 |
