Rotarix, cjepivo protiv rotavirusa, živo
The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
| Name | Rotarix, cjepivo protiv rotavirusa, živo |
|---|---|
| Active Substance | humani rotavirus, soj RIX4414 (živi, atenuirani) |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept (prašak i otapalo za oralnu suspenziju, oralna suspenzija) |
| Distribution | Supply through pharmacies (community) |
| ATC Code | J07BH01 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| Summary of product characteristics (SmPC), labelling and package leaflet (PL) | download |
| Link to the European Medicines Agency's (EMA) product information | download |
| Link to the European Commission's (EC) decisions | download |
