EMEA-001930-PIP01-16-M05 - paediatric investigation plan

Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid

N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid

N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid

N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW)

Key facts

• Invented name:
  MenQuadfi
• Active Substance:
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0186/2024
• PIP number:
  EMEA-001930-PIP01-16-M05
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of invasive meningococcal disease
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/05/2024

Decision

P/0186/2024: EMA decision of 29 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid ... (EMEA-001930-PIP01-16-M05)

AdoptedReference Number: EMA/246710/2024