Medicinal Products

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 micafunginum
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 Da
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download
Educational materials
for healthcare professionals
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