EMEA-000032-PIP02-22 - paediatric investigation plan

Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM)

Key facts

• Invented name:
  Menveo
• Active Substance:
  Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0116/2023
• PIP number:
  EMEA-000032-PIP02-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of meningococcal meningitis
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals Srl

  Email: [e-mail]

  Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/04/2023

Decision

P/0116/2023 : EMA decision of 13 April 2023 on the granting of a product specific waiver for meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) (EMEA-000032-PIP02-22)

AdoptedReference Number: EMA/103738/2023