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
EMEA-001766-PIP01-15-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: P/0528/2021
Route(s) of administration: Oral use
Pharmaceutical form(s):
Age-appropriate oral formulation
Film-coated tablet
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