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 mikafunginnatrij
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
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 Nestašica
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download
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