MHRA-100502-PIP01-22-M01 (update)

Key Facts

Active Substance
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
Invented Name
  • Supemtek
  • Supemtek
PIP Number MHRA-100502-PIP01-22-M01 (update)
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 infection
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 Check Procedure Number
Compliance procedure number
MHRA-100502-PIP01-22-M01-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 (Victoria lineage)Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage).pdf
Published Date 07/12/2022