Mikafungin Sandoz 50 mg prašak za otopinu za infuziju
| Name | Mikafungin Sandoz 50 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-184992739 |
| Active Substance | micafunginum |
| Pharmaceutical Form | prašak za otopinu za infuziju |
| Strength | 50 mg |
| Packaging [MA Number for Packaging] | 1 bočica s praškom, u kutiji [HR-H-184992739-01] |
| Manufacturer | BAG Health Care GmbH, Lich, Njemačka
SAG Manufacturing S.L.U., San Agustin del Guadalix, Madrid, Španjolska Lek Pharmaceuticals d.d., Ljubljana, Slovenija Galenicum Health S.L., Barcelona, Španjolska |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 21.07.2020 |
| MA Period of Validity | 21.07.2025 |
| Classification Number | UP/I-530-09/19-01/132 |
| Registration Number | 381-12-01/30-20-04 |
| Composition | svaka bočica sadrži mikafunginnatrij što odgovara 50 mg mikafungina. |
| 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 | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Kontrolna lista za propisivača, verzija1 |
