Adacel Polio, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno) i poliomijelitisa (inaktivirano) sa smanjenim sadržajem antigena, adsorbirano
| Name | Adacel Polio, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno) i poliomijelitisa (inaktivirano) sa smanjenim sadržajem antigena, adsorbirano |
|---|---|
| Marketing Authorisation Number | HR-H-773372732 |
| Active Substance | toksoid difterije toksoid tetanusa toksoid hripavca filamentozni hemaglutinin hripavca pertaktin hripavca fimbrijalni aglutinogeni hripavca 2 i 3 poliovirus tip 1, soj Mahoney (inaktiviran) poliovirus tip 2, soj MEF-1 (inaktiviran) poliovirus tip 3, soj Saukett (inaktiviran) |
| Composition | 1 doza (0,5 ml) sadrži: ≥ 2 IU (2 Lf) toksoida difterije, ≥ 20 IU (5 Lf) toksoida tetanusa, 2,5 mikrograma toksoida hripavca, 5 mikrograma filamentoznog hemaglutinina, 3 mikrograma pertaktina, 5 mikrograma fimbrija tipa 2 i 3, viruse polimijelitisa (inaktivirane, proizvedene u Vero stanicama): 29 D antigen jedinica - tip 1 (Mahoney), 7 D antigen jedinica - tip 2 (MEF-1), 26 D antigen jedinica - tip 3 (Saukett); adsorbirane na 1,5 mg aluminijeva fosfata (0,33 mg Al3+) |
| Pharmaceutical Form | suspenzija za injekciju u napunjenoj štrcaljki |
| Manufacturer | Sanofi-Aventis Zrt., Budimpešta, Mađarska
Sanofi Winthrop Industrie, Marcy L Etoile , Francuska Sanofi Winthrop Industrie, Val de Reuil, Francuska |
| Marketing Authorisation Holder | Sanofi Winthrop Industrie, 82, avenue Raspail, Gentilly, Francuska |
| Marketing Authorisation Date | 24.12.2024 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 22.07.2025* |
| Classification Number | UP/I-530-09/24-02/07 |
| Registration Number | 381-12-01/171-24-13 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J07CA02 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act, only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
