MHRA-100030-PIP01-21

Key Facts

Active Substance
Active Substance:
  • 9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa (ExPEC9V)
Invented Name
Not yet available
PIP Number MHRA-100030-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC)
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
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenicEscherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugatedto the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa(ExPEC9V).pdf
Published Date 07/12/2022