Medicinal Products

Anidulafungin Pliva 100 mg prašak za koncentrat za otopinu za infuziju

Name Anidulafungin Pliva 100 mg prašak za koncentrat za otopinu za infuziju
Marketing Authorisation Number HR-H-935077907
Active Substance anidulafungin
Composition jedna bočica sadrži 100 mg anidulafungina
Pharmaceutical Form prašak za koncentrat za otopinu za infuziju
Manufacturer Teva Operations Poland Sp. z o.o., Krakow, Poljska
Actavis Italy S.p.A., Nerviano (MI), Italija
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska
Teva Pharma B.V., Haarlem, Nizozemska
Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Marketing Authorisation Holder Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska
Marketing Authorisation Date 27.09.2022
MA Period of Validity unlimited
Classification Number UP/I-530-09/22-02/63
Registration Number 381-12-01/70-22-04
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code J02AX06
Medicinal product marketed in the Croatia Nestašica
SmPC download
PL download
Public Assessment Report download

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