| 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 |
21.08.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/24 |
| Registration Number |
381-12-01/171-24-03 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
ograničeni recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
J07BA01 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
