EMEA-000429-PIP01-08-M04 - paediatric investigation plan

Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid

Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid

N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid

Key facts

• Invented name:
  • Nimenrix
  • Nimenrix
• Active Substance:
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid
  • N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
• Therapeutic area:
  Vaccines
• Decision number:
  P/0089/2015
• PIP number:
  EMEA-000429-PIP01-08-M04
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of Meningococcal disease
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals SA

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/05/2015
• Compliance procedure number:
  EMEA-C-000429-PIP01-08-M04
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0089/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for N. meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / N...

Reference Number: EMA/211923/2015