MHRA-101392-PIP01-24

Key Facts

Active Substance
  • Influenza Virus Type A, H1N1
  • Influenza Virus Type A, H3N2
  • Influenza Virus Type B, Victoria lineage
Invented Name
Fluenz
PIP Number MHRA-101392-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Nasal spray, suspension
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of influenza infection
Route(s) of administration
Route(s) of administration:
  • NASAL 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
04/04/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101392-PIP01-24-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Influenza Virus Type A, H1N1Influenza Virus Type A, H3N2Influenza Virus Type B, Victoria lineage.pdf
Published Date 24/06/2024