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 |
| Packaging [MA Number for Packaging] | 1 bočica s praškom, u kutiji [HR-H-387813905-01] |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska Actavis Italy S.p.A., Nerviano (MI), Italija |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 11.10.2019 |
| MA Period of Validity | 11.10.2024 |
| Classification Number | UP/I-530-09/18-01/221 |
| Registration Number | 381-12-01/70-19-04 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J02AX05 |
| Medicinal product marketed in the Croatia | Nestašica |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Kontrolna lista za propisivača, verzija1 |
