Medicinal Products

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
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