Mikafungin Teva 50 mg prašak za koncentrat za otopinu za infuziju
| Name | Mikafungin Teva 50 mg prašak za koncentrat za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-387813905 |
| Active Substance | mikafunginnatrij |
| Composition | svaka bočica sadrži 50 mg mikafungina (u obliku mikafunginnatrija) |
| Pharmaceutical Form | Prašak za koncentrat za otopinu za infuziju |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska Merckle GmbH, Ulm, Njemačka |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 18.07.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/205 |
| Registration Number | 381-12-01/70-24-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J02AX05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
