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-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
EMEA-000325-PIP01-08-M10 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0258/2020
Route(s) of administration: Oral use
Pharmaceutical form(s):
Prolonged-release tablet
Prolonged-release granules
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000018-PIP01-07-M14 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0355/2017
Route(s) of administration: Oral useIntravenous use
Pharmaceutical form(s):
Film-coated tablet
Oral solution
Solution for injection/infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000018-PIP01-07-M12 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0315/2016
Route(s) of administration: Oral useIntravenous use
Pharmaceutical form(s):
Film-coated tablet
Oral solution
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000495-PIP01-08-M09 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0091/2016
Route(s) of administration: Oral useIntravenous use
Pharmaceutical form(s):
Film-coated tablet
Oral solution
Solution for injection/infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000494-PIP01-08-M09 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0092/2016
Route(s) of administration: Oral useIntravenous use
Pharmaceutical form(s):
Film-coated tablet
Oral solution
Solution for injection/infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000486-PIP01-08-M04 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: P/0044/2016
Route(s) of administration: Oral use
Pharmaceutical form(s):
Prolonged-release tablet
Prolonged-release granules
Decision date:
Last updated:
Compliance check: ✖
PIPHuman