MHRA-100030-PIP01-21

Key Facts

PIPS 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

PIPS Decision Documents
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