Anidulafungin Pliva 100 mg prašak za koncentrat za otopinu za infuziju
Name | Anidulafungin Pliva 100 mg prašak za koncentrat za otopinu za infuziju |
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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 |