Spikevax, cjepivo protiv COVID-19 (mRNA, modificirani nukleozid)
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 | Spikevax, cjepivo protiv COVID-19 (mRNA, modificirani nukleozid) |
|---|---|
| Former Name | COVID-19 Vaccine Moderna |
| Active Substance | jednolančana glasnička RNA (mRNA) s kapom na 5' kraju, koja kodira protein šiljka (S) virusa SARS-CoV-2, dobivena pomoću in vitro transkripcije iz odgovarajućih predložaka DNA, bez korištenja stanica |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | neponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | J07BN01 |
| 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 |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od miokarditisa i perikarditisa za mRNA cjepiva protiv bolesti COVID-19 Comirnaty i Spikevax | 19.07.2021 | BioNTech Manufacturing/Pfizer Croatia d.o.o., Moderna Biotech Spain, S.L. |
| Pismo zdravstvenim radnicima o ažuriranju roka valjanosti ovisno o uvjetima čuvanja za cjepivo protiv bolesti COVID-19 Spikevax (mRNA, modificiranih nukleozida) | 25.08.2022 | Moderna Biotech Spain, S.L. |
