MHRA-101748-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the strains: A/(H1N1)-Like Virus Antigen A/(H3N2)-Like Virus Antigen B/-Like Virus Antigen
Invented Name
  • Cell-based Trivalent Influenza Vaccine Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX
  • FLUCELVAX
  • FLUCELVAX
PIP Number MHRA-101748-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of influenza
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
13/03/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101748-PIP01-24-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the strains:A(H1N1)-Like Virus AntigenA(H3N2)-Like Virus AntigenB-Like Virus Antigen.pdf
Published Date 04/07/2025