Dultavax suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa i poliomijelitisa (inaktivirano), adsorbirano, smanjenog(ih) sadržaja antigena
| Name | Dultavax suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa i poliomijelitisa (inaktivirano), adsorbirano, smanjenog(ih) sadržaja antigena |
|---|---|
| Marketing Authorisation Number | HR-H-868511800 |
| Active Substance | toksoid difterije toksoid tetanusa poliovirus tip 1, soj Mahoney (inaktiviran) poliovirus tip 2, soj MEF-1 (inaktiviran) poliovirus tip 3, soj Saukett (inaktiviran) |
| Composition | jedna doza od 0,5 ml sadrži: Toksoid difterije ≥ 2 IU, Toksoid tetanus ≥ 20 IU, Inaktivirani virus poliomijelitisa, tip 1 (Mahoney) 29 D antigen jedinica, tip 2 (MEF-1) 7 D antigen jedinica, tip 3 (Saukett) 26 D antigen jedinica |
| Pharmaceutical Form | suspenzija za injekciju u napunjenoj štrcaljki |
| Manufacturer | Sanofi-Aventis Zrt., Budimpešta, Mađarska Sanofi Winthrop Industrie, Val de Reuil, Francuska Sanofi Winthrop Industrie, Marcy L Etoile , Francuska |
| Marketing Authorisation Holder | Sanofi Winthrop Industrie, 82, avenue Raspail, Gentilly, Francuska |
| Marketing Authorisation Date | 24.12.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/06 |
| Registration Number | 381-12-01/171-24-83 |
| 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 | J07CA01 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
