EMEA-001930-PIP01-16-M04 - 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:
  Vaccines
• Decision number:
  P/0222/2022
• PIP number:
  EMEA-001930-PIP01-16-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of invasive meningococcal disease
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Sanofi Pasteur

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  24/06/2022

Decision

P/0222/2022 : EMA decision of 24 June 2022 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-M04)

Reference Number: EMA/595648/2022