Boostrix, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa i pertusisa (nestanično, komponentno), adsorbirano, smanjenog(ih) sadržaja antigena
| Name | Boostrix, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa i pertusisa (nestanično, komponentno), adsorbirano, smanjenog(ih) sadržaja antigena |
|---|---|
| Marketing Authorisation Number | HR-H-889892563 |
| Active Substance | toksoid difterije toksoid tetanusa toksoid hripavca filamentozni hemaglutinin hripavca pertaktin hripavca |
| Composition | jedna doza (0,5 ml) sadrži: toksoid difterije ne manje od 2 IU (2,5 Lf), toksoid tetanusa ne manje od 20 IU (5Lf), toksoid hripavca 8 mikrograma, filamentozni hemaglutinin 8 mikrograma, pertaktin 2,5 mikrograma, adsorbirani na aluminijev hidroksid, hidratizirani Al (OH)3 0,3 miligrama Al 3+ i aluminijev fosfat (AlPO4) 0,2 miligrama Al 3+ |
| Pharmaceutical Form | suspenzija za injekciju u napunjenoj štrcaljki |
| Manufacturer | GlaxoSmithKline Biologicals S.A., Rixensart, Belgija |
| 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-530-09/20-02/156 |
| Registration Number | 381-12-01/70-21-11 |
| 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 | J07AJ52 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
