EMEA-000032-PIP01-07-M04 - 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
  • 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/93/2011
• PIP number:
  EMEA-000032-PIP01-07-M04
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Meningococcal meningitis
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GSK Vaccines S.r.l.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/04/2011
• Compliance procedure number:
  EMEA-C-000032-PIP01-07-M04
• Compliance opinion date:
  25/05/2011
• Compliance outcome:
  Positive

Decision

Meningococcal group A oligosaccharide Conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM), group C oligosaccharide Conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM), group W-135 oligosacch...

AdoptedReference Number: EMA/241589/2011