MHRA-100470-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, 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, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,
Invented Name
Not yet available
PIP Number MHRA-100470-PIP01-22
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
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):Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein,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,Neisseria meningitidis serogroup B fHbp subfamily A,Neisseria meningitidis serogroup B fHbp subfamily B,.pdf
Published Date 02/11/2022