Fluarix Tetra suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv influence (fragmentirani virion), inaktivirano
| Name | Fluarix Tetra suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv influence (fragmentirani virion), inaktivirano |
|---|---|
| Marketing Authorisation Number | HR-H-048213854 |
| 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 (0,5 ml) sadrži 15 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 | GlaxoSmithKline Biologicals (Branch of SmithKlineBeecham Pharma GmbH & Co. KG), Dresden, Njemačka |
| Marketing Authorisation Holder | GlaxoSmithKline Biologicals S.A., Rue de l'Institut 89, Rixensart, Belgija |
| Marketing Authorisation Date | 20.08.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/263 |
| Registration Number | 381-12-01/70-21-31 |
| Prescription | na recept |
| Type of prescription | neponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J07BB02 |
| Medicinal product marketed in the Croatia | Ne |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
