EMEA-000139-PIP01-07-M02

Key facts

Invented name
Bexsero
Active substance
  • recombinant Neisseria meningitidis group B NHBA fusion protein
  • recombinant Neisseria meningitidis group B NadA protein
  • recombinant Neisseria meningitidis group B fHbp fusion protein
  • Outer Membrane Vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
Therapeutic area
Vaccines
Decision number
P/0040/2018
PIP number
EMEA-000139-PIP01-07-M02
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Meningococcal meningitis
Route(s) of administration
Intramuscular use
Contact for public enquiries
GSK Vaccines S.r.l.
Tel. +44 2089663220
E-mail: eu.paediatric-plans@gsk.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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