Name |
Mikafungin Teva 100 mg prašak za koncentrat za otopinu za infuziju |
Marketing Authorisation Number |
HR-H-849833803 |
Active Substance |
mikafunginnatrij |
Composition |
svaka bočica sadrži 100 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-849833803-01]
|
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-530-09/18-01/222 |
Registration Number |
381-12-01/70-19-02 |
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 |
Nestašica |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |