Medicinal Products

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 na recept
Type of prescription neponovljivi recept
Distribution u ljekarni
ATC Code J07BX03
Medicinal product marketed in the Croatia Da
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

Direct Healthcare Professional Communication

Name Date Download
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.
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.
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