MHRA-101269-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
Invented Name
  • Celldemic
  • Audenz
PIP Number MHRA-101269-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of zoonotic 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
22/04/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101269-PIP01-23-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen.pdf
Published Date 24/06/2024