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 |