EMEA-001037-PIP02-11-M05 - paediatric investigation plan

Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia coli)

Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; Escherichia coli)

Key facts

• Active substance:
  • Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia coli)
  • Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; Escherichia coli)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0098/2019
• PIP number:
  EMEA-001037-PIP02-11-M05
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of invasive meningococcal disease caused by N. meningitidis serogroup B
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/03/2019
• Compliance check done:
  No

Decision

P/0098/2019: EMA decision of 22 March 2019 on the acceptance of a modification of an agreed paediatric investigation plan for neisseria meningitidis serogroup B recombinant lipoprotein / neisseria meningitidis serogroup B recombinant lipoprotein

Adopted Reference Number: EMA/122320/2019