| Name |
FSME-IMMUN 0,25 ml Junior, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv krpeljnog encefalitisa, inaktivirano |
| Marketing Authorisation Number |
HR-H-436912048 |
| Active Substance |
virus krpeljnog encefalitisa, soj Neudörfl (inaktiviran) |
| Composition |
jedna doza (0,25 ml) sadrži virus krpeljnog encefalitisa (soj Neudörfl) 1,2 mikrograma, adsorbiran na aluminijev hidroksid, hidratizirani (0,17 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-530-09/19-01/229 |
| Registration Number |
381-12-01/30-20-08 |
| 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 |
