MHRA-102032-PIP01-25-M01 (update)

Key Facts

Active Substance
  • Neisseria meningitidis group B fHBP protein subfamily A
  • Neisseria meningitidis group B fHBP protein subfamily B
Invented Name
  • Trumenba
  • Trumenba
  • Trumenba
PIP Number MHRA-102032-PIP01-25-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of invasive meningococcal disease caused by Neisseira meningitidis serogroup B
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
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-102032-PIP01-25-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Neisseria meningitidis group B fHBP protein subfamily ANeisseria meningitidis group B fHBP protein subfamily B.pdf
Published Date 18/12/2025