Efluelda Tetra, suspenzija za injekciju u napunjenoj štrcaljki, četverovalentno cjepivo protiv influence (fragmentirani virion), inaktivirano, 60 mikrograma HA/soju
| Name | Efluelda Tetra, suspenzija za injekciju u napunjenoj štrcaljki, četverovalentno cjepivo protiv influence (fragmentirani virion), inaktivirano, 60 mikrograma HA/soju |
|---|---|
| Marketing Authorisation Number | HR-H-238554415 |
| Active Substance | Soj virusa influence (inaktivirani, fragmentirani) Tip A (H1N1) Soj virusa influence (inaktivirani, fragmentirani) Tip A (H3N2) Soj virusa influence (inaktivirani, fragmentirani) Tip B |
| Composition | 1 doza (0,7 ml) sadrži 60 mikrograma hemaglutinina po soju virusa influence (inaktivirani, fragmentirani) za sezonu aktualnih sojeva tip A (H1N1), tip A (H3N2) i dva soja tipa B |
| Pharmaceutical Form | suspenzija za injekciju u napunjenoj štrcaljki |
| Manufacturer | Sanofi Pasteur, Val de Reuil, Francuska |
| Marketing Authorisation Holder | Sanofi Winthrop Industrie, 82, avenue Raspail, Gentilly, Francuska |
| Marketing Authorisation Date | 28.01.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/81 |
| Registration Number | 381-12-01/70-25-04 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | neponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J07BB02 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
