MHRA-101492-PIP01-24

Key Facts

Active Substance
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (RIV3)
Invented Name
Flublok
PIP Number MHRA-101492-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection in pre-filled syringe
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of influenza disease
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
05/08/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101492-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)Recombinant Influenza Hemagglutinin-strain B (RIV3).pdf
Published Date 03/10/2024