MHRA-100237-PIP01-21-M02 (update)

Key Facts

Active Substance
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
Invented Name
Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (QIV-HD)
PIP Number MHRA-100237-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection in pre-filled syringe
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of influenza infection
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100237-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)Split influenza virus, inactivated containing antigens equivalent to the AH1N1-like strainSplit influenza virus, inactivated containing antigens equivalent to the AH3N2-like strain.pdf
Published Date 04/07/2025