Spikevax (previously COVID-19 Vaccine Moderna) - direct healthcare professional communication (DHPC)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2)

About

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

Documents

Direct healthcare professional communication (DHPC): Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation

Key facts

• Medicine name:
  Spikevax (previously COVID-19 Vaccine Moderna)
• Active substance:
  CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2)
• Therapeutic area (MeSH):
  COVID-19 virus infection
• Regulatory outcome:
  Variation
• DHPC type:
  Adverse event
• Human ATC codes:
  J07BX03