EMEA-000036-PIP01-07-M06 - paediatric investigation plan

13-valent pneumococcal polysaccharide conjugate vaccine: pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F; diphtheria CRM197 conjugate

Key facts

• Invented name:
  • Prevenar 13
  • Prevenar 13
• Active substance:
  13-valent pneumococcal polysaccharide conjugate vaccine: pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F; diphtheria CRM197 conjugate
• Therapeutic area:
  Vaccines
• Decision number:
  P/0161/2012
• PIP number:
  EMEA-000036-PIP01-07-M06
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Disease caused by Streptococcus pneumoniae
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  05/04/2011
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000036-PIP01-07-M06
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0161/2012: EMA decision of 20 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide serotype 1 – diphtheria CRM197 conjugate, pneumococcal polysacchari...

Adopted Reference Number: EMA/474586/2012