Medicinal Products

Mikafungin Sandoz 100 mg prašak za otopinu za infuziju

Name Mikafungin Sandoz 100 mg prašak za otopinu za infuziju
Marketing Authorisation Number HR-H-521452432
Active Substance micafunginum
Composition svaka bočica sadrži mikafunginnatrij što odgovara 100 mg mikafungina
Pharmaceutical Form prašak za otopinu za infuziju
Packaging [MA Number for Packaging] 1 bočica s praškom, u kutiji  [HR-H-521452432-01]
Manufacturer BAG Health Care GmbH, Lich, Njemačka
SAG Manufacturing S.L.U., San Agustin del Guadalix, Madrid, Španjolska
Galenicum Health S.L., Barcelona, Španjolska
Lek Pharmaceuticals d.d., Ljubljana, Slovenija
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-530-09/19-01/133
Registration Number 381-12-01/30-20-02
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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