MHRA-101761-PIP01-24

Key Facts

Active Substance
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage)
Invented Name
  • Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
PIP Number MHRA-101761-PIP01-24
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
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage).pdf
Published Date 24/06/2025