MHRA-100502-PIP01-22-M02 (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
PIP Number MHRA-100502-PIP01-22-M02 (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 disease
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

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 03/10/2024