EMEA-001207-PIP06-22 - paediatric investigation plan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: P/0502/2022
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate and solvent for concentrate for solution for infusion
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001207-PIP02-19-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0296/2022
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
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
EMEA-001207-PIP01-11-M01 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: P/0196/2021
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-001207-PIP03-20 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/0512/2020
Route(s) of administration: Intravenous use
Pharmaceutical form(s):
Concentrate for solution for infusion
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