MHRA-101268-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1
Invented Name
  • Incellipan
  • Audenz
PIP Number MHRA-101268-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of pandemic influenza
Route(s) of administration
Route(s) of administration:
  • Intramuscular 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
15/05/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101268-PIP01-23-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1.pdf
Published Date 24/06/2024