Name |
Cefepim Accord 1 g prašak za otopinu za injekciju/ infuziju |
Marketing Authorisation Number |
HR-H-204713554 |
Active Substance |
cefepimdiklorid hidrat |
Composition |
jedna bočica sadrži 1 g cefepima u obliku cefepimdiklorid hidrata |
Pharmaceutical Form |
Prašak za otopinu za injekciju / infuziju |
Manufacturer |
Laboratorio Farmaceutico C.T. S.r.l., Sanremo-IM, Italija |
Marketing Authorisation Holder |
Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
Marketing Authorisation Date |
06.04.2020 |
MA Period of Validity |
06.04.2025 |
Classification Number |
UP/I-530-09/19-01/182 |
Registration Number |
381-12-01/70-20-04 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
J01DE01 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |