Spikevax (previously COVID-19 Vaccine Moderna)
COVID-19 mRNA vaccine
elasomeran
elasomeran / imelasomeran
elasomeran / davesomeran
andusomeran
COVID-19 virus infection
Date of authorisation:
Revision: 45
Last updated:
MedicineHumanAuthorised
EMEA-003224-PIP01-22 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-HepatologyInfectious diseases
PIP number: P/0371/2022
Route(s) of administration: Oral use
Pharmaceutical form(s):
Granules
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-002893-PIP01-20-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseasesVaccines
PIP number: P/0256/2022
Route(s) of administration: Intramuscular use
Pharmaceutical form(s):
Dispersion for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Comirnaty / Spikevax (previously COVID-19 Vaccine Moderna) - direct healthcare professional communication (DHPC)
Active substance: Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2CX-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)
DHPC type:
Safety signal
Last updated:
DHPCHuman