MHRA-100177-PIP01-21-M02 (update)

Key Facts

Active Substance
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
Invented Name
  • FLUCELVAX TETRA
  • Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX TETRA
PIP Number MHRA-100177-PIP01-21-M02 (update)
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
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
16/06/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100177-PIP01-21-M02-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGENINFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGENINFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGENINFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN.pdf
Published Date 24/08/2023