EMEA-000139-PIP01-07-M03 - paediatric investigation plan

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

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/0334/2019
• PIP number:
  EMEA-000139-PIP01-07-M03
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Meningococcal meningitis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/09/2019
• Compliance procedure number:
  EMEA-C-000139-PIP01-07-M03
• Compliance opinion date:
  15/11/2019
• Compliance outcome:
  Positive

Decision

P/0334/2019: EMA decision of 11 September 2019 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Neisseria meningitidis group B NHBA fusion protein / recombinant Neisseria meningitidis group B NadA protein...

AdoptedReference Number: EMA/466392/2019