Name |
FSME-IMMUN 0,5 ml, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv krpeljnog encefalitisa, inaktivirano |
Marketing Authorisation Number |
HR-H-946437793 |
Active Substance |
virus krpeljnog encefalitisa, soj Neudörfl (inaktiviran) |
Composition |
jedna doza (0,5 ml) sadrži virus krpeljnog encefalitisa (soj Neudörfl) 2,4 mikrograma,
adsorbiran na aluminijev hidroksid, hidratizirani (0,35 miligrama Al3+), umnožen na fibroblastima pilećih embrija
|
Pharmaceutical Form |
suspenzija za injekciju u napunjenoj štrcaljki |
Manufacturer |
Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgija |
Marketing Authorisation Holder |
Pfizer Croatia d.o.o., Slavonska avenija 6, Zagreb, Hrvatska |
Marketing Authorisation Date |
05.02.2020 |
MA Period of Validity |
05.02.2025 |
Classification Number |
UP/I-530-09/19-01/230 |
Registration Number |
381-12-01/30-20-06 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
J07BA01 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |