MHRA-100470-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
Invented Name
Not yet available
PIP Number MHRA-100470-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • powder and suspension for suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
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):Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier proteinNeisseria meningitidis serogroup B fHbp subfamily ANeisseria meningitidis serogroup B fHbp subfamily BNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier proteinNeisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier proteinNeisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein.pdf
Published Date 19/12/2023