MHRA-101495-PIP01-24

Key Facts

Active Substance
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Split influenza virus, inactivated containing antigens equivalent to B-like strain
Invented Name
not available
PIP Number MHRA-101495-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of influenza disease
Route(s) of administration
  • Subcutaneous use
  • intramuscular
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 Check Procedure Number
Compliance procedure number
MHRA-101495-PIP01-24-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strainSplit influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strainSplit influenza virus, inactivated containing antigens equivalent to B-like strain.pdf
Published Date 28/10/2024